Health-related quality of life among patients with facial acne -- assessment of a new acne-specific questionnaire.

The psychosocial effects of facial acne are well accepted but until recently few validated instruments existed which were suitable for use in clinical trials. The aim of this study was to assess measurement characteristics (reproducibility, correlation with acne severity, and sensitivity to detect change after acne therapy) of a new acne-specific quality of life instrument, the Acne-QoL. We found that the Acne-QoL is reliable, valid and able to distinguish differences across severity groups and improvement over 16 weeks of standard therapy. The use of the Acne-QoL should aid physicians in understanding the impact of facial acne on young adults, and may be useful in assessing therapeutic effects in acne clinical trials.

A randomized trial of the efficacy of a new micronized formulation versus a standard formulation of isotretinoin in patients with severe recalcitrant nodular acne.

BACKGROUND: Isotretinoin is very frequently the drug of choice for the management of severe recalcitrant nodular acne. Recently, a new micronized and more bioavailable formulation of isotretinoin has been developed that permits once-daily administration in lower doses than usually used with standard isotretinoin (Accutane), regardless of whether it is taken with or without food. OBJECTIVE: Our purpose was to determine whether micronized isotretinoin and standard isotretinoin are clinically equivalent. METHODS: In this multicenter, double-blind, double-dummy study, 600 patients with severe recalcitrant nodular acne were treated with either 0.4 mg/kg of micronized isotretinoin once daily without food (n = 300) or 1.0 mg/kg per day of standard isotretinoin in two divided doses with food (n = 300). Lesion counts were monitored over 20 weeks. RESULTS: Both treatment groups in this well-controlled clinical trial experienced an equivalent reduction in the number of total nodules (facial plus truncal). In addition, an equivalent proportion of patients achieved 90% clearance of the total number of nodules. Both formulations had similar results for other efficacy variables. CONCLUSION: Once-daily use of the micronized and more bioavailable formulation of isotretinoin under fasted conditions is clinically equivalent to the standard twice-daily formulation under fed conditions in the treatment of severe recalcitrant nodular acne.

Safety of a new micronized formulation of isotretinoin in patients with severe recalcitrant nodular acne: A randomized trial comparing micronized isotretinoin with standard isotretinoin.

BACKGROUND: Isotretinoin is a very effective drug for treating severe recalcitrant nodular acne. A new micronized formulation of isotretinoin has been shown to be clinically equivalent to standard isotretinoin with improved bioavailability and minimal food effect. The safety profile of the micronized formulation has not been described previously. OBJECTIVE: The objective of this article is to report the incidence and intensity of adverse events found in a comparative, double-blind efficacy study that showed clinical equivalence of the new micronized formulation of isotretinoin and the standard isotretinoin formulation (Accutane). METHODS: Six hundred patients with severe recalcitrant nodular acne were treated with micronized isotretinoin (n = 300) under fasted conditions or standard isotretinoin (n = 300) under fed conditions. One cohort received single daily doses of 0.4 mg/kg of micronized isotretinoin without food and the other cohort received 1.0 mg/kg per day of standard isotretinoin in two divided doses with food. Adverse events were monitored during 20 weeks of drug therapy. RESULTS: The proportion of adverse events in most body systems was generally lower in patients receiving micronized isotretinoin than in those receiving standard isotretinoin. CONCLUSION: Micronized isotretinoin appears to have a safety profile similar to that of standard isotretinoin and to carry a lower risk of mucocutaneous events and hypertriglyceridemia.

Treatment of acne with a combination clindamycin/benzoyl peroxide gel compared with clindamycin gel, benzoyl peroxide gel and vehicle gel: combined results of two double-blind investigations.

BACKGROUND: It has previously been shown that a combination of erythromycin and benzoyl peroxide is superior to either ingredient when used alone in the treatment of acne. A clindamycin/benzoyl peroxide combination gel might have an advantage over erythromycin/benzoyl peroxide gel because the former does not require refrigeration after it is dispensed. OBJECTIVE: Our purpose was to determine the efficacy and safety of a combination clindamycin/benzoyl peroxide gel when compared with benzoyl peroxide, clindamycin, or vehicle gels. METHODS: In two double-blind, randomized, parallel, vehicle-controlled trials, patients were treated for 11 weeks with once-nightly application of one of the above preparations. Evaluations were performed at 2, 5, 8, and 11 weeks and included lesion counts and assessment of global responses and irritant effects. RESULTS: A total of 334 patients completed the study. All three active preparations were significantly superior to the vehicle in global improvement and in reducing inflammatory lesions and noninflammatory lesions. The combination gel was significantly superior to the two individual agents in global improvement and reduction of inflammatory lesions and also to the clindamycin gel in reducing noninflammatory lesions. There was no significant difference in tolerance to the active gels versus the vehicle gel. CONCLUSION: In the treatment of acne, topical clindamycin/benzoyl peroxide combination gel is well tolerated and superior to either individual ingredient.

Actinic damage and skin cancer in albinos in northern Tanzania: findings in 164 patients enrolled in an outreach skin care program.

Persons with albinism are particularly vulnerable to the deleterious effects of UV light on their skin. We obtained histories and performed skin examinations on 164 albino patients living in equatorial Africa to determine their sun exposure, sun protection, and sun damage. Many patients did not wear hats and most wore short-sleeved shirts. Except for four infants, all patients had sunburned skin. Actinic cheilitis, actinic keratoses, and skin cancers were detected in many patients. Sun protection methods will be important for prevention of skin damage in albino patients.

Cutaneous metastases in patients with metastatic carcinoma: a retrospective study of 4020 patients.

BACKGROUND: Most previous studies have found that cutaneous metastases occur infrequently and are rarely present at the time the cancer is initially diagnosed. OBJECTIVE: We studied patients with metastatic cancer to determine the overall frequency of skin metastases, the frequency that these were the first sign of extranodal disease, and the clinical and histologic features of the cutaneous lesions. METHODS: A 10-year period of tumor registry files was searched for patients with metastatic carcinoma and melanoma. For patients with skin metastases, medical records and pathology reports were also examined. RESULTS: Of 4020 patients with metastatic disease, 420 (10%) had cutaneous metastases; in 306 of them the skin metastases were the first sign of extranodal metastatic Breast cancer and melanoma were the most common. Nodules were the most frequent clinical presentation, although inflammatory, cicatricial, and bullous lesions were also noted. Incisional metastases were common. Histologic findings most frequently revealed adenocarcinoma that was sometimes suggestive of the site of origin. After recognition of skin metastases, mean patient survival ranged from 1 to 34 months depending on tumor type. CONCLUSION: Cutaneous metastases are not uncommon and frequently are the first sign of extranodal metastatic disease, particularly in patients with melanoma, breast cancer, or mucosal cancers of the head and neck.

A clinical and pathologic study of histiocytosis X in adults.

BACKGROUND: Histiocytosis X is a neoplastic disorder of Langerhans cells that usually occurs in children. Because histiocytosis X rarely occurs in adults, the diagnosis can frequently be missed by both clinicians and pathologists. OBJECTIVE: The purpose of this investigation was to characterize the clinical and pathologic findings of histiocytosis X in adults. METHODS: A retrospective study of four adults with histiocytosis X was undertaken. Paraffin-embedded biopsy specimens were stained with a panel of antibodies including S-100, vimentin, Ham-56, leukocyte common antigen, proliferating cell nuclear antigen (PCNA), UCHL-1, CD43, and Ki-1. RESULTS: The predominant lesions were papules and pustules that usually involved the groin, axilla, and scalp. Histologically the infiltrate exhibited a periappendageal distribution. Strong positive staining for PCNA appeared to correlate with the clinical course. CONCLUSION: Histiocytosis X in adults has a predilection for skin sites rich in appendages and histologically shows a periappendageal infiltrate. PCNA staining of the histiocytes may indicate progressive disease and serve as a useful prognostic marker.

Verruciform xanthoma in an immunocompromised patient: a case report and immunohistochemical study.

The etiology of verruciform xanthoma, a rare lesion that usually occurs in the oral mucosa, is unknown. A viral etiology has been speculated since extraoral lesions usually occur in the genitalia. We present, to the best of our knowledge, the first reported case of verruciform xanthoma in an immunocompromised patient with chronic graft versus host disease. Immunohistochemical studies showed a few Ham 56 (a macrophage marker) positive foam cells, both in the dermis and within the epidermis, supporting a role for an epidermal process in production of the foam cells. Staining for human papillomavirus protein (HPV) showed reactivity of some of the nuclei in the dermal histiocytes, but in situ hybridization for HPV types 6/11, 16/18, and 31, 33 was negative. These results support an epidermal process as the stimulus for the foam cell formation but fail to demonstrate HPV as the cause.

Inocoterone and acne. The effect of a topical antiandrogen: results of a multicenter clinical trial.

BACKGROUND AND METHODS: Because acne is androgen dependent, antiandrogen therapy might improve the condition. Inocoterone acetate (RU 882) is a nonsteroidal antiandrogen that binds to the androgen receptor and has antiandrogenic activity in animal models. To test its topical effect on acne, 126 male subjects with facial acne completed a 16-week, multi-center, double-blind study in which the twice-daily application of a 10% solution of inocoterone was compared with vehicle solution. Baseline and monthly examinations included acne lesion counts and general and endocrine laboratory tests. RESULTS: Inflammatory papules and pustules showed greater reduction in the inocoterone-treated subjects than in the subjects treated with vehicle. This difference achieved statistical significance by week 12 (24% reduction vs 10%) and week 16 (26% reduction vs 13%) and, with longitudinal analysis, throughout the course of the study. Global assessments and changes in comedo counts and sebum excretion rates were not significantly different between the groups. No serious adverse reactions were encountered. CONCLUSIONS: In this double-blind study of 126 male subjects with acne, a topical solution of the antiandrogen inocoterone, compared with vehicle, produced a modest but statistically significant reduction in the number of inflammatory acne lesions.

Clinical and biochemical parameters of androgen action in normal healthy Caucasian versus Chinese subjects.

Stimulation of androgen-sensitive hair follicles is mediated by dihydrotestosterone (DHT), which is formed in these tissues by 5 alpha-reduction of testosterone. A possible mechanism for increased body hair in some human populations might, therefore, be an increase in 5 alpha-reductase activity, resulting in elevated tissue levels of DHT. If present, this finding could have other important clinical implications, since the 5 alpha-reductase enzyme is pivotal in the pathophysiology of prostatic disease. To explore differences in clinical and biochemical parameters of androgen action, we conducted a study of 184 caucasian and Chinese subjects in whom we evaluated chest hair density and serum levels of androgen precursors and 5 alpha-reduced androgen metabolites. Differences in chest hair density were most notable in the men, in whom comparative mean chest hair scores (using a scale of 0-4) were 3.0 vs. 0.8 (P less than 0.0001), caucasian vs. Chinese. Levels of 5 alpha-reduced androgen products were also strikingly higher in the caucasian vs. Chinese subjects. Serum 3 alpha-androstanediol glucuronide levels (nanomoles per L) were 34.7 +/- 2.4 vs. 19.7 +/- 0.9 (P less than 0.001) for the men and 21.5 +/- 3.2 vs. 9.4 +/- 0.6 (P less than 0.001) for the women, and serum levels of androsterone glucuronide (nanomoles per L) were 179 +/- 26 vs. 107 +/- 7 (P less than 0.01) for the caucasian vs. Chinese men and 173 +/- 23 vs. 81 +/- 9 (P less than 0.001) for the women. Serum levels of total and bioavailable testosterone did not differ between the racial groups, but serum levels of the precursor androgens, dehydroepiandrosterone sulfate and androstenedione, were significantly higher in the caucasian vs. Chinese men, but not in the women. We conclude that increased serum levels of 5 alpha-reduced androgen metabolites in caucasians vs. Chinese subjects provide circumstantial evidence for a racial difference in 5 alpha-reductase activity and suggest a mechanism for the increased body hair observed in the caucasian men. Increased levels of precursor androgens may also play a role.