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Clinical dose ranging studies with finasteride, a type 2 5alpha-reductase inhibitor, in men with male pattern hair loss.
J Am Acad Dermatol. 1999 Oct; 41(4):555-63.JA

Abstract

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.

Authors+Show Affiliations

Northwest Cutaneous Research Specialists, Portland, Oregan, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

10495375

Citation

Roberts, J L., et al. "Clinical Dose Ranging Studies With Finasteride, a Type 2 5alpha-reductase Inhibitor, in Men With Male Pattern Hair Loss." Journal of the American Academy of Dermatology, vol. 41, no. 4, 1999, pp. 555-63.
Roberts JL, Fiedler V, Imperato-McGinley J, et al. Clinical dose ranging studies with finasteride, a type 2 5alpha-reductase inhibitor, in men with male pattern hair loss. J Am Acad Dermatol. 1999;41(4):555-63.
Roberts, J. L., Fiedler, V., Imperato-McGinley, J., Whiting, D., Olsen, E., Shupack, J., Stough, D., DeVillez, R., Rietschel, R., Savin, R., Bergfeld, W., Swinehart, J., Funicella, T., Hordinsky, M., Lowe, N., Katz, I., Lucky, A., Drake, L., Price, V. H., ... Gencheff, C. (1999). Clinical dose ranging studies with finasteride, a type 2 5alpha-reductase inhibitor, in men with male pattern hair loss. Journal of the American Academy of Dermatology, 41(4), 555-63.
Roberts JL, et al. Clinical Dose Ranging Studies With Finasteride, a Type 2 5alpha-reductase Inhibitor, in Men With Male Pattern Hair Loss. J Am Acad Dermatol. 1999;41(4):555-63. PubMed PMID: 10495375.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Clinical dose ranging studies with finasteride, a type 2 5alpha-reductase inhibitor, in men with male pattern hair loss. A1 - Roberts,J L, AU - Fiedler,V, AU - Imperato-McGinley,J, AU - Whiting,D, AU - Olsen,E, AU - Shupack,J, AU - Stough,D, AU - DeVillez,R, AU - Rietschel,R, AU - Savin,R, AU - Bergfeld,W, AU - Swinehart,J, AU - Funicella,T, AU - Hordinsky,M, AU - Lowe,N, AU - Katz,I, AU - Lucky,A, AU - Drake,L, AU - Price,V H, AU - Weiss,D, AU - Whitmore,E, AU - Millikan,L, AU - Muller,S, AU - Gencheff,C, PY - 1999/9/25/pubmed PY - 1999/9/25/medline PY - 1999/9/25/entrez SP - 555 EP - 63 JF - Journal of the American Academy of Dermatology JO - J Am Acad Dermatol VL - 41 IS - 4 N2 - 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. SN - 0190-9622 UR - https://www.unboundmedicine.com/medline/citation/10495375/Clinical_dose_ranging_studies_with_finasteride_a_type_2_5alpha_reductase_inhibitor_in_men_with_male_pattern_hair_loss_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0190-9622(99)80052-8 DB - PRIME DP - Unbound Medicine ER -