Background: A keloid is an overgrowth of dense fibrous tissue that usually develops after healing of a skin injury. The tissue extends beyond the borders of the original wound, does not usually regress spontaneously, and tends to recur after excision.
The first description of keloids (recorded on papyrus) concerned surgical techniques used in Egypt in 1700 BCE. Subsequently, in 1806, Alibert used the term cheloide, derived from the Greek chele, or crab's claw, to describe the lateral growth of tissue into unaffected skin.
Pathophysiology: Hypertrophic scars and keloids can be described as variations of typical wound healing. In a typical wound, anabolic and catabolic processes achieve equilibrium approximately 6-8 weeks after the original injury. At this stage, the strength of the wound is approximately 30-40% that of healthy skin. As the scar matures, the tensile strength of the scar improves as a result of progressive cross-linking of collagen fibers. At this point, the scar is usually hyperemic and it may be thickened, but it tends to subside gradually over months until a flat, white, pliable, possibly stretched, mature scar has developed. When an imbalance occurs between the anabolic and catabolic phases of the healing process, more collagen is produced than is degraded, and the scar grows in all directions. The scar is elevated above the skin and remains hyperemic. Excessive scar tissue is classified either as a keloid or a hypertrophic scar.
Kischer and Brody declared the collagen nodule to be the identifying structural unit of hypertrophic scars and keloids. The nodule, which is absent from mature scars, contains a high density of fibroblasts and unidirectional collagen fibrils in a highly organized and distinct orientation. In addition, keloids and hypertrophic scars differ from healthy skin by a rich vasculature, high mesenchymal cell density, and thickened epidermal cell layer. Attempts to differentiate keloids from hypertrophic scars have proved to be difficult in the early phases of formation. Clinical differences become more apparent as lesions mature. The most consistent histologic difference is the presence of broad, dull, pink bundles of collagen in keloids, which are not present in hypertrophic scars.
Mortality/Morbidity: Keloids and hypertrophic scars located at most sites are primarily of cosmetic concern; however, some keloids or hypertrophic scars can cause contractures, which may result in loss of function if overlying a joint or in significant disfigurement if located on the face. Keloids and hypertrophic scars can be both painful and pruritic.
Keloids and hypertrophic scars are associated genetically with HLA-B14, HLA-B21, HLA-Bw16, HLA-Bw35, HLA-DR5, HLA-DQw3, and blood group A. Transmission is reported as both autosomal dominant and autosomal recessive.
Race: Keloids form more frequently in Polynesian and Chinese persons than in Indian and Malaysian persons. As many as 16% of people in a random sampling of black Africans reported having keloids. White and albino persons are least commonly affected.
Sex: The prevalence has been reported to be higher in young females than in young males, probably reflecting the greater frequency of earlobe piercing among females. Keloids and hypertrophic scars affect both sexes equally in other age groups.
Age: Onset occurs most commonly in individuals aged 10-30 years. Keloids occur less frequently at the extremes of age, although an increasing number of presternal keloids have resulted from coronary artery bypass operations and other similar procedures now undertaken in persons in older age groups.
CLINICAL Section 3 of 11
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History: Keloids and hypertrophic scars do not usually cause symptoms, but they may be tender, painful, or pruritic or they may cause a burning sensation. In addition to symptomatic relief, cosmetic concern is the primary reason patients seek medical intervention.
Physical:
Origins of lesions
Keloids manifest as exaggerated growths of scar tissue, usually in areas of previous trauma. Keloids extend past the areas of trauma, projecting above the level of the surrounding skin, but they rarely extend into underlying subcutaneous tissue.
Hypertrophic scars remain limited to the traumatized area and regress spontaneously within 12-18 months, although regression may not necessarily be complete.
Clinical findings in lesions
Keloids range in consistency from soft and doughy to rubbery and hard. Recent studies have demonstrated how to differentiate and classify keloids according to how they feel.
Early lesions are often erythematous.
Lesions become brownish red and then pale as they age.
Lesions are usually devoid of hair follicles and other functioning adnexal glands.
Once lesions occur, the clinical course varies. Most lesions continue to grow for weeks to months and others grow for years. Growth is usually slow, but keloids occasionally enlarge rapidly, tripling in size within months. Once they stop growing, keloids do not usually cause symptoms and remain stable or involute slightly.
Keloids on the ears, neck, and abdomen tend to be pedunculated.
Keloids on the central chest and extremities are usually raised with a flat surface, and the base is often wider than the top.
Most keloids are round, oval, or oblong with regular margins; however, some have clawlike configurations with irregular borders.
Most patients present with 1 or 2 keloids; however, a few patients, especially patients with spontaneous keloids, have multiple lesions, as do patients who develop keloids as a consequence of acne or chickenpox.
Keloids overlying a joint can contract and restrict movement.
Frequency of lesion sites
In white persons, keloids tend to be present, in decreasing order of frequency, on the face (with cheek and earlobes predominating), upper extremities, chest, presternal area, neck, back, lower extremities, breast, and abdomen.
In black persons, the descending order of frequency tends to be earlobes, face, neck, lower extremities, breast, chest, back, and abdomen.
In Asian persons, the descending order of frequency is earlobes, upper extremities, neck, breast, and chest.
Causes: No specific gene or set of genes has been identified as allowing keloids to develop; however, the increased prevalence of keloids paralleling increased cutaneous pigmentation suggests a genetic basis or, at least, a genetic linkage. Trauma to the skin, both physical (eg, earlobe piercing, surgery) and pathological (eg, acne, chickenpox), is the primary cause identified for developing keloids. DIFFERENTIALS Section 4 of 11
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WORKUP Section 5 of 11
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Lab Studies:
Diagnosis is usually based on clinical findings. Biopsy helps confirm the diagnosis in case of uncertainty.
Histologic Findings: Formation of collagen in keloids and hypertrophic scars in the inflammatory stage takes much longer than usual in healing wounds. Collagen fibers in granulation tissue are arranged in a whorled pattern. The nodules grow and eventually show thick, compacted, hyalinized bands of collagen lying in a concentric arrangement. In keloids, the condensation of collagen persists indefinitely, while in hypertrophic scars, the thick hyalinized collagen bundles gradually thin and straighten out so that the orientation of the collagen bundles appears parallel to the free surface of the skin.
TREATMENT Section 6 of 11
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Medical Care: No single therapeutic modality is best for all keloids. The location, size, and depth of the lesion; the age of the patient; and the past response to treatment determine the type of therapy used. Prevention is key, but therapeutic treatment of hypertrophic scars and keloids includes occlusive dressings, compression therapy, intralesional corticosteroid injections, cryosurgery, excision, radiation therapy, laser therapy, interferon therapy, imiquimod 5% cream, and other promising but lesser-known therapies directed at collagen synthesis.
Prevention: This is the first rule in keloid therapy.
Avoid performing nonessential cosmetic surgery in patients known to form keloids; however, do not consider patients who have only earlobe lesions to be among those who form keloids.
Close all surgical wounds with minimal tension.
Incisions should not cross joint spaces.
Avoid making midchest incisions, and ensure that incisions follow skin creases whenever possible.
Standard treatments: These include occlusive dressings, compression therapy, and intralesional corticosteroid injections.
Occlusive dressings include silicone gel sheets and dressings, nonsilicone occlusive sheets, Cordran tape, and Scarguard. These measures have been used with varied success. Antikeloidal effects appear to result from a combination of occlusion and hydration, rather than from an effect of the silicone.
Previous studies have shown that in patients treated with silicone occlusive sheeting with pressure worn 24 h/d for up to 12 months, 34% showed excellent improvement, 37.5% showed moderate improvement, and 28% demonstrated no or slight improvement.
Of patients treated with semipermeable, semiocclusive, nonsilicone-based dressings for 8 weeks, 60% experienced flattening of keloids, 71% had reduced pain, 78% had reduced tenderness, 80% had reduced pruritus, 87.5% had reduced erythema, and 90% were satisfied with the treatment.
Cordran tape is a clear surgical tape that contains flurandrenolide, a steroid that is uniformly distributed on each square centimeter of the tape, and it has been shown to soften and flatten keloids over time.
Scarguard is a topical medication containing silicone, hydrocortisone, and vitamin E. In an in vitro study, Scarguard stimulated the release of inactive collagenase precursors that may inhibit new scars from forming and may reduce existing scars. In a pilot study of 12 patients, Scarguard was applied twice daily after the removal of a mole and nothing was applied after the removal of a second mole. After 2 months, 9 of 12 patients reported that the treated scar was less red and less noticeable compared with the untreated scar.
Compression therapy involves pressure, which has long been known to have thinning effects on skin. Reduction in the cohesiveness of collagen fibers in pressure-treated hypertrophic scars has been demonstrated by electron microscopy.
Compression treatments include button compression, pressure earrings, ACE bandages, elastic adhesive bandages, compression wraps, Lycra bandages, and support bandages. In one study, button compression (2 buttons sandwiching the earlobe applied after keloid excision) prevented recurrence during 8 months to 4 years of follow-up observation.
Other pressure devices include pressure earrings and pressure-gradient garments made of lightweight porous Dacron, spandex (also known as elastane), or bobbinet fabric (usually worn 12-24 h/d) and zinc oxide adhesive plaster. Overall, 60% of patients treated with these devices showed 75-100% improvement.
Corticosteroids, specifically intralesional corticosteroid injections, have been the mainstay of treatment. Corticosteroids reduce excessive scarring by reducing collagen synthesis, altering glucosaminoglycan synthesis, and reducing production of inflammatory mediators and fibroblast proliferation during wound healing. The most commonly used corticosteroid is triamcinolone acetonide (TAC) in concentrations of 10-40 mg/mL administered intralesionally with a 25- to 27-gauge needle at 4- to 6-week intervals.
Intralesional steroid therapy as a single modality and as an adjunct to excision has been shown to be efficacious in various studies. Response rates varied from 50-100%, with recurrence rates of 9-50% in completely resolved scars.
When combined with excision, postoperative intralesional TAC injections yielded a recurrence rate of 0-100%, with most studies citing a rate of less than 50%.
Complications of repeated corticosteroid injections include atrophy, telangiectasia formation, and pigmentary alteration.
Recent innovations: New treatments for keloids and hypertrophic scars include intralesional interferon, verapamil, bleomycin, 5-fluorouracil (5-FU), retinoic acid, imiquimod, tacrolimus, and botulinum toxin.
Interferon therapy, including interferon alfa, interferon beta, and interferon gamma, has been demonstrated in in vitro studies to reduce keloidal fibroblast production of collagen I, III, and VI mRNA.
Interferon alfa and interferon beta also reduce fibroblast production of glycosaminoglycans (GAGs), which form the scaffolding for deposition of dermal collagen. Interferon gamma enhances GAG production.
Interferon alfa, interferon beta, and interferon gamma have been shown to increase collagenase activity. Studies have shown that interferon gamma modulates a p53 apoptotic pathway by inducing apoptosis-related genes. p53 is a protein synthesized following DNA damage. Once damage is repaired, p53 is degraded. Mutations of this protein are believed to predispose cells to hyperproliferation, possibly resulting in keloid formation. In addition, p53 is a potent suppressor of interleukin (IL)–6, a cytokine implicated in hyperproliferative and fibrotic conditions.
Interferon injected into the suture line of keloid excision sites may be prophylactic for reducing recurrences. Berman and Flores reported statistically significant fewer keloid recurrences in a study of 124 keloid lesions after postoperative interferon alfa-2b injection treatment (5 million U, 1 million U injected per cm of scar) into keloid excision sites (18%) versus excision alone (51.1%) and TAC treatment (58.4%).
Verapamil is a calcium channel blocker that blocks the synthesis/secretion of extracellular matrix molecules (eg, collagen, GAGs, fibronectin) and increases fibrinase. In a study of 22 patients with keloids, patients were treated with surgical excision and 5 treatments of verapamil at 2.5 mg/mL (doses varied from 0.5-5 mL, depending on the size of the keloid) over a 2-month period and were evaluated at 2-year follow-up. Two patients had keloids that decreased in size from the original lesion, 2 patients had hypertrophic scars, 4 patients had pruritus, and 1 patient had a keloid on the donor site.
Bleomycin injections cause necrosis of keratinocytes with a mixed inflammatory infiltrate. In 2 studies, bleomycin was used to treat keloids and hypertrophic scars. In one study, bleomycin was given at a concentration of 1.5 IU/mL to 13 patients using the multiple-puncture method. Bleomycin was dripped onto the lesion, and then multiple punctures were made on the lesions by means of a syringe. Seven patients had complete flattening, 5 patients had highly significant flattening, and 1 patient had significant flattening. In another study of 31 keloids, patients were treated with 3-5 infiltrates of bleomycin within a 1-month period. Total regression occurred in 84% of the keloids, and both keloid volume and functional impairment were reduced.
5-FU, a pyrimidine analog, inhibits fibroblastic proliferation in tissue culture and is believed to reduce postoperative scarring by decreasing fibroblast proliferation. 5-FU has also been shown to be safe and effective in the treatment and prevention of hypertrophic scars and to be somewhat responsive in small keloids. Two studies have shown the effectiveness of 5-FU.
In one prospective, randomized, uncontrolled trial, 28 patients were treated with weekly injections of 0.5-2 mL at a 50-mg/mL concentration of 5-FU for 12 weeks. At the 24-week follow-up, 70% of the patients had more than 50% improvement in keloid size.
In the other retrospective study of 1000 patients with hypertrophic scars and keloids over a 9-year period, the most effective regimen was found to be 0.1 mL of TAC (10 mg/mL) and 0.9 mL of 5-FU (50 mg/mL) up to 3 times a week.
Retinoic acid decreases normal tonofilament and keratohyalin synthesis, increases production of mucoid substances and epidermal cell growth rate, and inhibits DNA synthesis in vitro. In a clinical trial involving 21 patients with 28 keloids and hypertrophic scars, topical retinoic acid was applied for at least 3 months twice daily and showed favorable results in 77-79% of the lesions. This includes a decrease in the size and symptoms of the scar.
Imiquimod induces tumor necrosis factor-alpha (TNF-alpha), interferon-alpha and interferon-gamma, IL-1, IL-6, IL-8, and IL-12 and alters the expression of markers for apoptosis. In one study, 13 keloids were treated with excision in combination with nightly applications of imiquimod for 8 weeks. Ten patients with 11 keloids completed the 6-month study, and no keloids recurred after 6 months. Mild irritation was experienced with the application of imiquimod, and some patients needed a vacation period from the medication. Hyperpigmentation was experienced by more than half of the patients in the study.
Tacrolimus is an immunomodulator that inhibits TNF-alpha. gli-1, an oncogene, has been found to be overexpressed in fibroblasts of keloids. Rapamycin, a close analogue of tacrolimus, was used in an in vitro study and was found to inhibit the gli-1 oncogene, thus giving a rationale to initiate clinical trials of topical tacrolimus and rapamycin. In an open-label pilot study, 11 patients used tacrolimus 0.1% ointment twice daily for 12 weeks on their keloids. Although the results were not statistically significant, the study showed a decrease in induration, tenderness, erythema, and pruritus for most patients.
Radiation therapy
Using radiotherapy to treat keloids remains controversial. Although many studies have demonstrated efficacy and decreased recurrence rates, the safety of radiotherapy has been questioned.
In one retrospective study of superficial x-ray therapy of 24 excised keloids, the author reported a recurrence rate of 53%. Use of iridium Ir 192 interstitial irradiation after excisional surgery resulted in a 21% recurrence rate after 1 year. Excisional surgery and preoperative hyaluronidase solution (150 U/mL NaCl) followed by external radiation (7.2-10.8 Gy) had a 0% recurrence rate. Adjunctive high dose rate brachytherapy (192Ir) used after excision and closure resulted in a 12% reoccurrence rate after 26 months.
When excisional surgery is followed by postoperative radiation therapy, the total fractionated dose should be a minimum of 12 Gy, according to a comparative study showing a higher recurrence rate for patients treated with total doses less than 12 Gy.
Surgical Care:
Cryotherapy
Cryosurgical media (eg, liquid nitrogen) affects the microvasculature and causes cell damage via intracellular crystals, leading to tissue anoxia.
Generally, 1, 2, or 3 freeze-thaw cycles lasting 10-30 seconds each are used for the desired effect. Treatment may need to be repeated every 20-30 days. Take care to administer liquid nitrogen in short application periods because of the possibility of reversible hypopigmentation. Cryotherapy can cause pain and depigmentation in selected patients.
As a single modality, cryosurgery led to total resolution with no recurrences in 51-74% of patients after 30 months of follow-up observation.
Excision
Apply basic soft tissue handling techniques at primary wound repair sites.
Carefully plan closure with minimal tension, paralleling the relaxed skin tension lines.
Use buried sutures when necessary for layered closure and to reduce tension.
Whenever feasible, apply pressure dressings and garments during the immediate postoperative period to wounds of patients in whom hypertrophic scars and keloid formation occur.
Decreased recurrence rates have been reported with excision in combination with other postoperative modalities, such as radiotherapy, injected interferon, or corticosteroids.
Excisional surgery alone has been shown to yield a 45-100% recurrence rate and should very rarely be used as a solitary modality, although excision in combination adjunct measures can be curative. Most studies in which excisional surgery was combined with injected steroids indicated less than 50% recurrence.
The authors recently reported the effects of topically applied imiquimod 5% cream (Aldara), which induces local production of interferons at the site of application, on the postexcision recurrence rates of 13 keloids excised surgically from 12 patients.
Starting the night of surgery, imiquimod 5% cream was applied for 8 weeks. Patients were examined at weeks 4, 8, 16, and 24 for local erythema, edema, erosions, pigment alteration, and/or recurrence of keloid.
Of the 11 keloids evaluated at 24 weeks, none (0%) recurred. The rate of hyperpigmentation was 63.6%. Two cases of mild irritation and superficial erosion cleared with temporary discontinuation of imiquimod. Both patients completed the 8 weeks of topical therapy and the final 24-week assessment.
At 24 weeks, the recurrence rate of excised keloids treated with postoperative imiquimod 5% cream was lower than recurrence rates previously reported in the literature.
Laser therapy
Ablation of keloids and hypertrophic scars using a carbon dioxide laser (10,600 nm) can cut and cauterize the lesion, creating a dry surgical environment with minimal tissue trauma. When used as a single modality, the carbon dioxide laser was associated with recurrence rates of 39-92%, and when combined with postoperative injected steroids, it was associated with recurrence rates of 25-74%.
The argon laser (488 nm), similar to the carbon dioxide laser, can induce collagen shrinkage via generation of excessive localized heat. The argon laser has demonstrated recurrence rates of 45-93%.
The pulsed dye laser (585 nm) provides photothermolysis, resulting in microvascular thrombosis. Beginning in the 1980s, authors noted that scars became less erythematous, more pliable, and less hypertrophic after treatment with the 585-nm pulsed dye laser. The findings were later confirmed using objective measurements of erythema by reflectance spectrometry readings, scar height, and pliability measurements. The pulsed dye laser remains the laser treatment of choice for hypertrophic scars, because of its efficacy, safety, and relatively low cost.
The Nd:YAG laser (1064 nm) has demonstrated recurrence rates of 53-100%.
Other potential therapies
Additional potential therapeutic options for treating hypertrophic and keloidal scarring that have been shown in vitro to affect collagen synthesis include the use of proline-cis-hydroxyproline and azetidine carboxylic acid, tranilast (antiallergic drug shown to decrease collagen and GAG synthesis), and pentoxifylline (inhibits DNA replication).
In addition, wounds treated with anti–transforming growth factor healed with minimal scar tissue formation and without affecting wound tensile strength. A possible candidate for affecting wounds via the neutralizing effect of transforming growth factor is the proteoglycan termed decorin.
MEDICATION Section 7 of 11
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Drug Category: Corticosteroids -- Most commonly used corticosteroid is TAC.Drug Name
Triamcinolone (Amcort, Aristocort) -- Decreases inflammation by suppressing migration of polymorphonuclear leukocytes and reversing capillary permeability. Approved by US Food and Drug Administration (FDA) for use in keloids.
Adult Dose 10-40 mg (10-mg/mL or 40-mg/mL formulations) administered intralesionally with a 25- to 27-gauge needle q4-6wk
Pediatric Dose Safety for use in children with keloids not established
Contraindications Documented hypersensitivity; fungal, viral, and bacterial skin infections
Interactions Coadministration with barbiturates, phenytoin, or rifampin decreases effects
Pregnancy C - Safety for use during pregnancy has not been established.
Precautions Multiple complications (eg, severe infections, hyperglycemia, edema, osteonecrosis, myopathy, peptic ulcer disease, hypokalemia, osteoporosis, euphoria, psychosis, myasthenia gravis, growth suppression) may occur; abrupt discontinuation may cause adrenal crisis
Drug Category: Interferons -- Family of glycoproteins produced mainly by eukaryotic cells when induced by viral and nonviral triggers. Antiviral properties include induction of 2'-5' A synthetase, ribonuclease L, and protein kinase P1. Antiproliferative properties include induction of 2'-5' A synthetase, inhibition of growth factors, enhancement of p53, and down-regulation of c-myc, c-fos, and certain c-ras. Immunoregulatory properties include induction of class I and II MHC antigens, increase of natural killer cells, and inhibition of the production of TH-2 cytokines.Drug Name
Interferon (Roferon-A, Intron-A, Rebetron, Alferon-N, Peg-Intron, Avonex) -- Protein product manufactured by recombinant DNA technology. Not approved by FDA for use in hypertrophic scars and keloids.
Adult Dose Variable; can be administered intralesionally
Pediatric Dose Safety for use in children with keloids not established
Contraindications Documented hypersensitivity or hypersensitivity to products derived from Escherichia coli
Interactions Coadministration with aminophylline, zidovudine, and IL-2
Pregnancy C - Safety for use during pregnancy has not been established.
Precautions Multiple complications (eg, influenzalike symptoms, rhabdomyolysis, hypotension, dysrhythmia, tachycardia, spastic diplegia, depression, suicide behavior, nausea, diarrhea) can occur
Drug Category: Calcium channel blockers Drug Name
Verapamil (Isoptin, Calan, Covera-HS, Verelan PM) -- Blocks synthesis/secretion of extracellular matrix molecules. Not approved by FDA for use in hypertrophic scars and keloids.
Adult Dose 2.5mg/mL (vary from 0.5-5 mL depending on size of keloid) intralesionally
Pediatric Dose Safety for use in children with keloids not established
Contraindications Severe LV dysfunction, hypotension, sick sinus syndrome, second- or third-degree AV block without pacemaker, atrial flutter/fibrillation, or accessory bypass tracts; also contraindicated with grapefruit juice
Interactions Drugs metabolized by CYP3A4, CYP1A2, and CYP2C (eg, erythromycin, calcium channel blockers, ketoconazole, cimetidine)
Pregnancy C - Safety for use during pregnancy has not been established.
Precautions Adverse effects include constipation, dizziness, nausea, hypotension, headaches, edema, CHF, bradycardia, AV block, dyspnea, rash, and flushing
Drug Category: Antineoplastics Drug Name
Bleomycin (Blenoxane) -- Injections cause necrosis of keratinocytes. Not approved by FDA for use in hypertrophic scars and keloids.
Adult Dose 1.5 IU/mL using multiple-puncture method (ie, puncturing skin and dripping medication into openings)
Pediatric Dose Safety for use in children with keloids not established
Contraindications Documented hypersensitivity
Interactions Decreases digoxin and phenytoin levels
Pregnancy D - Unsafe in pregnancy
Precautions Local adverse effects include pain, swelling, and Raynaud phenomenon; systemic toxicity includes myelosuppression, hyperpigmentation, hyperkeratosis, ulceration, pulmonary fibrosis, headache, nausea, vomiting, hyperthermia, and hypotension
Drug Name
Fluorouracil (5FU, Carac, Efudex, Fluoroplex) -- Pyrimidine analog that inhibits fibroblastic proliferation in tissue culture and is believed to reduce postoperative scarring by decreasing fibroblast proliferation. Not approved by FDA for use in hypertrophic scars and keloids.
Adult Dose 0.5-2 mL (depending on size of keloid) at 50-mg/mL concentration given intralesionally weekly for 12 wk
Pediatric Dose Safety for use in children with keloids not established
Contraindications Documented hypersensitivity; dihydropyrimidine dehydrogenase enzyme deficiency
Interactions None reported
Pregnancy X - Contraindicated in pregnancy
Precautions May cause irritation and photosensitivity
Drug Category: Retinoid acid derivatives -- Decrease normal tonofilament and keratohyalin synthesis, increase production of mucoid substances and epidermal cell growth rate, and inhibit DNA synthesis in vitro.Drug Name
Tretinoin (Retin-A, Retin-A Micro, Renova, Retisol-A, Stievaa) -- Not approved by FDA for use in hypertrophic scars and keloids.
Adult Dose Apply small amount to keloid topically
Pediatric Dose Safety for use in children with keloids not established
Contraindications Documented hypersensitivity
Interactions Drugs that inhibit or enhance P450
Pregnancy C - Safety for use during pregnancy has not been established.
Precautions Topical adverse effects include skin irritation, including erythema, peeling, dryness, and pruritus
Drug Category: Immunosuppressants Drug Name
Tacrolimus (Protopic) -- Immunomodulator that inhibits TNF-alpha. Not approved by FDA for use in hypertrophic scars and keloids.
Adult Dose Apply small amount to keloid topically
Pediatric Dose Safety for use in children with keloids not established
Contraindications Documented hypersensitivity
Interactions Drugs that inhibit CYP3A4 (eg, erythromycin, calcium channel blockers, ketoconazole, cimetidine)
Pregnancy C - Safety for use during pregnancy has not been established.
Precautions Common adverse effects include skin burning, pruritus, flulike symptoms, erythema, headache, infections, and folliculitis
Drug Category: Topical skin products Drug Name
Imiquimod (Aldara) -- Immune response modifier currently approved for treatment of genital and perianal warts. Capable of inducing interferon-alpha, TNF-alpha, IL-1, IL-6, and IL-8.
Studies using 5% cream in mice showed significant induction of interferon-alpha at application side occurring as early as 2 h after treatment. At 4 h after application, increases in interferon-alpha mRNA levels were found, indicating increase in transcription.
Not approved by FDA for use in hypertrophic scars and keloids.
Adult Dose Apply hs to excision suture line for 2 mo
Pediatric Dose Safety for use in children with keloids not established
Contraindications Documented hypersensitivity
Interactions None reported
Pregnancy B - Usually safe but benefits must outweigh the risks.
Precautions In keloid excision sites, 7 (63.6%) of 11 evaluated at 24 wk exhibited mild hyperpigmentation
FOLLOW-UP Section 8 of 11
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Further Outpatient Care:
Because of the high rate of recurrence, a follow-up period of at least 1 year is necessary to fully evaluate the effectiveness of therapy.
Close follow-up monitoring is vital during immediate and aggressive treatment of subsequent keloid formation. Noncompliant patients who are lost to follow-up care for months often return for further evaluation long after further adjunct treatment would have been most beneficial.
Preoperative evaluation is critical to assess a patient's motivation for treatment and to assess the patient's ability to participate in long-term care and follow-up visits.
Deterrence/Prevention:
Advise patients to avoid sharp trauma to the skin.
Minimize inflammation resulting from acne or surgery.
Complications:
Trauma to the keloid may predispose the lesion to erosion and localized bacterial infection.
Prognosis:
Keloids rarely resolve spontaneously; however, with treatment, they may become softer, less tender, less painful, and less pruritic.
Following excision treatment alone, keloids frequently recur (>50%).
2006-09-11 08:29:18
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