A Novel Topical Dutasteride Lotion (FOL100) for Male Pattern Baldness in Israeli Men: A Phase I Study of Safety, Tolerability, Usability, and Exploratory Efficacy

January 2026 in “ Dermatologic Therapy ”

Anna Lyakhovitsky, Avner Shemer, Amir Koren, Helena Martínez, Doron Friedman, Soli Brawer, Inbal Ziv, Yuval Ramot

dutasteride FOL100 male pattern baldness finasteride follicular unit density Propecia

TLDR FOL100 lotion is safe and effective for increasing hair growth in men with male pattern baldness.

The Phase I study evaluated the safety, tolerability, usability, and exploratory efficacy of FOL100, a novel topical dutasteride lotion, in 79 Israeli men with mild-to-moderate male pattern baldness. Participants received either FOL100 (66 men) or oral finasteride (13 men) for 24 weeks. FOL100 showed excellent safety, with mild and transient adverse events in 10.6% of participants and no detectable serum dutasteride levels, indicating minimal systemic absorption. Usability and tolerability were rated favorably, and exploratory efficacy analysis revealed a significant increase in hair count and improvements in follicular unit density. The study concluded that FOL100 has promising clinical benefits, warranting further placebo-controlled studies.

View this study on doi.org →

Discuss this study in the Community →

Research cited in this study

24 / 24 results

research Effectiveness and Safety of Topical Finasteride for Male Androgenetic Alopecia: Real World Data

March 2026 in “International Journal of Dermatology”

Topical finasteride effectively and safely improves hair growth in men with androgenetic alopecia.

Is the Safety of Finasteride Correlated With Its Route of Administration: Topical Versus Oral? A Pharmacovigilance Study With Data From the United States Food and Drug Administration Adverse Event Reporting System

research Is the Safety of Finasteride Correlated With Its Route of Administration: Topical Versus Oral? A Pharmacovigilance Study With Data From the United States Food and Drug Administration Adverse Event Reporting System

July 2025 in “International Journal of Dermatology”

Topical finasteride may be safer than oral finasteride, but more research is needed.

Development of Ethosomes for the Topical Treatment of Androgenic Alopecia: Ethanol Effect on Dutasteride Targeting to the Hair Follicles

research Development of Ethosomes for the Topical Treatment of Androgenic Alopecia: Ethanol Effect on Dutasteride Targeting to the Hair Follicles

June 2025 in “Pharmaceutics”

Ethosomes with 30% ethanol effectively deliver dutasteride to hair follicles for treating hair loss.

research Contact Dermatitis Caused by Topical Minoxidil: Allergy or Just Irritation

April 2025 in “Acta Dermato Venereologica”

Accurate diagnosis is crucial to distinguish between allergy and irritation from topical minoxidil.

research Efficacy And Safety Of Dutasteride In The Treatment Of Alopecia: A Comprehensive Review

January 2025 in “Expert Opinion on Pharmacotherapy”

Dutasteride is more effective than finasteride for hair loss but may affect male fertility and should be used cautiously.

Comparative Study Between Fractional CO2 Laser Alone Versus Fractional CO2 Laser Combined With Topical Dutasteride in Treatment of Male Androgenic Alopecia

research Comparative Study Between Fractional CO2 Laser Alone Versus Fractional CO2 Laser Combined With Topical Dutasteride in Treatment of Male Androgenic Alopecia

January 2025 in “Lasers in Medical Science”

Combining fractional CO2 laser with topical dutasteride is more effective for treating male hair loss than using the laser alone.

research Comparing Adherence, Side Effects, And Satisfaction In Oral And Topical Minoxidil: A Cross-Sectional Study

January 2025 in “Journal of Drugs in Dermatology”

Oral minoxidil is easier to use and more satisfying for hair loss treatment than topical minoxidil.

research Topical Dutasteride for Androgenic Alopecia: Current State and Prospects

December 2024 in “Therapeutic Delivery”

Topical dutasteride shows promise for hair loss but needs more research.

research Evaluation of Dutasteride-Loaded Liposomes and Transfersomes for Follicular Targeting in Androgenic Alopecia Topical Treatment

November 2024 in “Pharmaceutics”

Transfersomes are better than liposomes for targeting hair follicles in alopecia treatment.

Efficacy of Topical Finasteride 0.25% With Minoxidil 5% Versus Topical Minoxidil 5% Alone in the Treatment of Male Pattern Androgenic Alopecia

research Efficacy of Topical Finasteride 0.25% With Minoxidil 5% Versus Topical Minoxidil 5% Alone in the Treatment of Male Pattern Androgenic Alopecia

October 2024 in “Journal of Drugs in Dermatology”

Combining finasteride with minoxidil is more effective for male hair loss than using minoxidil alone.

research Patient Perspectives on Topical Minoxidil for Hair Loss: A Survey-Based Study from the University of Michigan Alopecia Clinic

February 2024 in “Archives of Dermatological Research”

Most patients know about minoxidil for hair loss, but concerns about its use and effectiveness affect their decision to use it.

research Intradermal Delivery of Alopecia Therapeutics: Current State and Future Prospects

June 2023 in “Dermatologic Surgery”

New injection methods for hair loss treatment show promise but need more research.

research What's New in Therapy for Male Androgenetic Alopecia?

2 citations , September 2022 in “American Journal of Clinical Dermatology”

research Microneedling Plus Topical Dutasteride Solution for Androgenetic Alopecia: A Randomized Placebo-Controlled Study

June 2022 in “Journal of The European Academy of Dermatology and Venereology”

Microneedling with topical dutasteride improves hair growth in men with hair loss and is safe to use.

research The Psychological Consequences of Androgenetic Alopecia: A Systematic Review

1 citations , April 2022 in “Journal of Cosmetic Dermatology”

Androgenetic alopecia causes significant psychological distress, especially in women, and requires both medical and psychological support.

research Relative Efficacy of Minoxidil and the 5-Alpha Reductase Inhibitors in Androgenetic Alopecia Treatment of Male Patients

13 citations , February 2022 in “JAMA Dermatology”

Dutasteride is the most effective hair loss treatment after 24 weeks, but finasteride leads to the most hair growth after 48 weeks.

research Nanostructured Drug Delivery Systems for Targeting 5-Alpha-Reductase Inhibitors to the Hair Follicle

3 citations , January 2022 in “Pharmaceutics”

Nanostructured delivery systems could potentially improve hair loss treatment by targeting drugs to hair follicles, reducing side effects and dosage, but the best size, charge, and materials for these systems need further investigation.

research Efficacy and Safety of Topical Finasteride Spray Solution for Male Androgenetic Alopecia: A Phase III, Randomized, Controlled Clinical Trial

11 citations , October 2021 in “Journal of The European Academy of Dermatology and Venereology”

Topical finasteride is an effective and safer treatment for male hair loss.

research In Vitro Performance of Dutasteride-Nanostructured Lipid Carriers Coated with Lauric Acid-Chitosan Oligomer for Dermal Delivery

8 citations , October 2020 in “Pharmaceutics”

Dutasteride-loaded nanoparticles coated with Lauric Acid-Chitosan show promise for treating hair loss due to their controlled release, low toxicity, and potential to stimulate hair growth.

research Novel Iron Oxide Nanocarriers Loading Finasteride or Dutasteride: Enhanced Skin Penetration for Topical Treatment of Alopecia

12 citations , July 2020 in “International Journal of Pharmaceutics”

Iron oxide nanoparticles improve skin penetration and drug release for hair loss treatment.

research Topical Antiandrogen Therapies for Androgenetic Alopecia and Acne Vulgaris

7 citations , December 2019 in “American Journal of Clinical Dermatology”

Topical therapies show promise for hair loss and acne treatment with minimal side effects.

The Efficacy and Safety of Dutasteride Compared with Finasteride in Treating Men with Androgenetic Alopecia: A Systematic Review and Meta-Analysis

research The Efficacy and Safety of Dutasteride Compared with Finasteride in Treating Men with Androgenetic Alopecia: A Systematic Review and Meta-Analysis

38 citations , February 2019 in “Clinical Interventions in Aging”

Dutasteride more effectively treats hair loss than finasteride, but may increase risk of altered libido.

A Randomized, Active- and Placebo-Controlled Study of the Efficacy and Safety of Different Doses of Dutasteride Versus Placebo and Finasteride in the Treatment of Male Subjects with Androgenetic Alopecia

research A Randomized, Active- and Placebo-Controlled Study of the Efficacy and Safety of Different Doses of Dutasteride Versus Placebo and Finasteride in the Treatment of Male Subjects with Androgenetic Alopecia

97 citations , January 2014 in “Journal of The American Academy of Dermatology”

Dutasteride 0.5 mg works better than finasteride and placebo for increasing hair in men with hair loss.

research Treatment of Hair Loss

370 citations , September 1999 in “The New England Journal of Medicine”

Finasteride and minoxidil are effective for hair loss, but continued research is needed for better treatments.