Janet L. Roberts

Alopecia areata investigational assessment guidelines

From Duke University Medical Center, Durhama; University of Minnesota, Minneapolisb; Pontefract General Infirmaryc; University of California at San Franciscod; Northwest Cutaneous Research Specialists, Portlande; The University of British Columbia, Vancouverf; and Johnson & Johnson, Skin Biology Research Center, Skillman.g Reprint requests: Elise A. Olsen, MD, Professor of Medicine, Duke University Medical Center, Box 3294, Durham, NC 27710. J Am Acad Dermatol 1999;40:242-6. *Developed from the Alopecia Areata Consensus meeting sponsored by the National Alopecia Areata Foundation at the First Tricontinental Meeting of the Hair Research Societies, Brussels, Belgium, Oct 8, 1995. Participants are listed at the end of the guidelines. Copyright

Finasteride increases anagen hair in men with androgenetic alopecia

Background The growth of scalp hair is a cyclical process of successive phases of growth (anagen) and rest (telogen). In previous clinical trials in men with androgenetic alopecia, treatment with finasteride increased scalp hair counts in a defined area (i.e. increased hair density). Objectives The current study used a phototrichogram methodology to assess the effect of finasteride on the phases of the hair growth cycle. Patients/Methods Two hundred and twelve men, age 18–40 years, with androgenetic alopecia were randomized to receive finasteride 1 mg daily or placebo for 48 weeks. At baseline and at 24 and 48 weeks, macrophotographs were taken to measure total and anagen hair count in a 1‐cm2 target area of the scalp. Results At baseline, mean total and anagen hair counts in the finasteride group were 200 and 124 hairs, respectively (% anagen = 62%) and the anagen to telogen ratio was 1·74 (geometric mean). In the placebo group, the respective values were 196 and 119 hairs (% anagen = 60%) and 1·57. At week 48, the finasteride group had a net improvement (mean ± SE) compared with placebo in total and anagen hair counts of 17·3 ± 2·5 hairs (8·3% ± 1·4%) and 27·0 ± 2·9 hairs (26% ± 3·1%), respectively (P < 0·001). Furthermore, treatment with finasteride resulted in a net improvement in the anagen to telogen ratio of 47% (P < 0·001). In this study, treatment with finasteride 1 mg day−1 for 48 weeks increased both total and anagen hair counts, and improved the anagen to telogen ratio. Conclusions These data provide direct evidence that finasteride 1 mg daily promotes the conversion of hairs into the anagen phase. These data support that finasteride treatment results in favourable effects on hair quality that contribute to the visible improvements in hair growth observed in treated patients.

Clinical dose ranging studies with finasteride, a type 2 5α-reductase inhibitor, in men with male pattern hair loss

BACKGROUND Androgenetic alopecia is a common condition of adult men. Finasteride, a type 2 5alpha-reductase inhibitor, decreases the formation of dihydrotestosterone from testosterone. OBJECTIVE Two separate clinical studies were conducted to establish the optimal dose of finasteride in men with this condition. METHODS Men from 18 to 36 years of age with moderate vertex male pattern hair loss received finasteride 5, 1, 0.2, or 0.01 mg/day or placebo based on random assignment. Efficacy was determined by scalp hair counts, patient self-assessment, investigator assessment, and assessment of clinical photographs. Safety was assessed by clinical and laboratory measurements and by analysis of adverse experiences. RESULTS Efficacy was demonstrated for all end points for finasteride at doses of 0.2 mg/day or higher, with 1 and 5 mg demonstrating similar efficacy that was superior to lower doses. Efficacy of the 0.01 mg dose was similar to placebo. No significant safety issues were identified in the trials. CONCLUSION Finasteride 1 mg/day is the optimal dose for the treatment of men with male pattern hair loss and was subsequently identified for further clinical development.

CD4+ T-cell-directed antibody responses are maintained in patients with psoriasis receiving alefacept: results of a randomized study.

BACKGROUND Alefacept, human LFA-3/IgG(1) fusion protein, selectively reduces memory-effector (CD45RO(+)) T cells, a source of the pathogenic mediators of psoriasis. OBJECTIVE To evaluate the effect of alefacept on immune function, T-cell-dependent humoral responses to a neoantigen (PhiX174) and recall antigen (tetanus toxoid) were assessed. METHODS Patients with psoriasis were randomized to the control group or to receive alefacept (7.5 mg intravenously weekly for 12 weeks). The alefacept group received PhiX174 immunizations at weeks 6, 12, 20, and 26 and tetanus toxoid at week 21; control subjects received PhiX174 at weeks 6 and 12 and tetanus at week 10. RESULTS Mean anti-PhiX174 titers were comparable in both groups. There was no difference in the percentage of responders (anti-PhiX174 IgG >/=30% of the total anti-PhiX174) between the alefacept group and the control group (86% and 82%, respectively; P =.73). The percentage of patients with anti-tetanus toxoid titer increases >/=2 times baseline also was similar (alefacept, 89%; control 91%). CONCLUSION A single 12-week course of alefacept did not impair primary or secondary antibody responses to a neoantigen or memory responses to a recall antigen. The selective immunomodulatory effect of alefacept against a potentially pathogenic T-cell subset is associated with maintenance of a significant aspect of immune function (antibody response) to fight infection and respond to vaccinations.

Subcutaneous efalizumab is not effective in the treatment of alopecia areata

BACKGROUND Alopecia areata (AA) is a T-cell-mediated autoimmune disease. Efalizumab is a T-cell-targeted therapy approved for the treatment of psoriasis. OBJECTIVE To assess the efficacy and safety of efalizumab in the treatment of moderate-to-severe AA. METHODS Sixty-two patients were enrolled into this phase II, placebo-controlled trial. The trial consisted of three 12-week periods-a double-blind treatment period, an open-label efalizumab treatment period, and a safety follow-up. RESULTS There were no statistical differences between treatment groups in percent hair regrowth, quality-of-life measures, or changes in biologic markers of disease severity after 12 or 24 weeks. In both groups, there was an approximately 8% response rate for hair regrowth (at 12 weeks). Efalizumab was well tolerated. LIMITATIONS Numbers were too small for certain analyses. CONCLUSION A 3- to 6-month trial of efalizumab was not effective in promoting hair regrowth in this small cohort of patients with moderate-to-severe AA.

Androgenetic alopecia: Treatment results with topical minoxidil

A double-blind 12-month trial was conducted to evaluate the safety and efficacy of topical minoxidil in patients with androgenetic alopecia. During the first 4 months of the study, patients applied a topical solution containing either 2% minoxidil, 3% minoxidil, or placebo to their scalps twice daily. At the end of the fourth month, patients taking placebo were crossed over to treatment with 3% minoxidil solution. Of 60 patients enrolled in the study, 43 were evaluable at month 12. Hairs were counted in a 1-inch target area and classified as vellus, indeterminate, and terminal; the latter two classifications were combined as nonvellus hairs for further statistical analysis. All three groups had significant increases in total, nonvellus, and terminal hair counts between baseline and month 4 and between month 4 and month 12. At month 4 the average total hair counts increased from a baseline mean of 158.2 to 270.2 in the 2% minoxidil group, from 156.6 to 287.0 in the 3% minoxidil group, and from 162.6 to 246.9 in the placebo group. At month 12 the means were 415.6, 448.5, and 471.1 in the 2% minoxidil, 3% minoxidil, and placebo-3% minoxidil crossover subjects, respectively. The increases from month 4 to month 12 were highly significant for each group (p = 0.0001). Average increases in nonvellus hair counts between months 4 and 12 were 216, 181, and 264 in the 2% minoxidil, 3% minoxidil, and placebo-to-3% minoxidil crossover groups, respectively, all highly significant differences from zero (p = 0.0001).(ABSTRACT TRUNCATED AT 250 WORDS)

Central scalp alopecia photographic scale in African American women.

ABSTRACT:  Central centrifugal cicatricial alopecia (CCCA) is a common but poorly understood cause of hair loss in African American women. A photographic scale was developed that captures the pattern and severity of the central hair loss seen with CCCA in order to help identify this problem in the general community and to potentially correlate clinical data with hair loss. The utility and reproducibility of this photographic scale was determined in a group of 150 African American women gathered for a health and beauty day who were evaluated by both four investigators experienced in the diagnosis of hair disorders and by the subjects themselves.

Melanocytes: A possible autoimmune target in alopecia areata

fold decrease; Fig 1, B). Thus, IPL treatment appears to be able to modify UVB-induced activation of AP-1 transcription. We next investigated whether IPL treatment may also alter the expression of MMP-1 in vitro. As shown in Fig 1, C, MMP-1 expression by fibroblasts was increased after UVB treatment (1.56-fold, compared with control), a finding that is in accordance with previous reports, while IPL treatment decreased the MMP-1 expression level by 11.47-fold (vs control), which is conistent with the report by Luo et al. In summary, we have provided limited evidence for the possible molecular mechanisms that govern the photorejuvenation effect of IPL treatment by demonstrating that IPL may downregulate the AP-1 expression enhanced by UVB. More investigation will be necessary to solidify the relevance of IPL’s influence on AP-1 expression to downstream signaling events and its photorejuvenation effects.

Clinical utility and validity of minoxidil response testing in androgenetic alopecia

Clinical response to 5% topical minoxidil for the treatment of androgenetic alopecia (AGA) is typically observed after 3–6 months. Approximately 40% of patients will regrow hair. Given the prolonged treatment time required to elicit a response, a diagnostic test for ruling out nonresponders would have significant clinical utility. Two studies have previously reported that sulfotransferase enzyme activity in plucked hair follicles predicts a patients response to topical minoxidil therapy. The aim of this study was to assess the clinical utility and validity of minoxidil response testing. In this communication, the present authors conducted an analysis of completed and ongoing studies of minoxidil response testing. The analysis confirmed the clinical utility of a sulfotransferase enzyme test in successfully ruling out 95.9% of nonresponders to topical minoxidil for the treatment of AGA.

Hair Loss and Hirsutism in the Elderly

This article contains a brief review of hair follicle biology, followed by a presentation of the workup of elderly patients who present with hair loss or hirsutism. Common hair disorders, such as graying, telogen effluvium, androgenic alopecia, senescent alopecia, alopecia arcuata, hirsutism, and hypertrichosis, are discussed.