The Pharmacokinetics of Topical Finasteride 0.25% Spray in Chinese Adult Male Volunteers with Androgenic Alopecia: A Phase I Study

February 2025 in “ Advances in Therapy ”

Zongguang Tai, Zhen Cui, Xinwei Shi, Haiyan Li, Rongrong Chai, Yanping Huang, Yuanyuan Fang, Dongmei Jia, Quangang Zhu, Zhongjian Chen

finasteride topical finasteride androgenetic alopecia pharmacokinetics Propecia

TLDR The topical finasteride spray was safe and well-tolerated with stable effects.

This Phase I study assessed the pharmacokinetics, safety, and tolerability of a 0.25% topical finasteride spray in 12 Chinese male volunteers with androgenetic alopecia. Participants applied the spray once daily for 7 days. Results indicated a stable half-life, minimal changes in clearance rate, and approximately twofold accumulation in exposure compared to a single dose. The maximum concentration after 7 days was 29.7 ± 12.9 pg/mL. The treatment was well tolerated, with no significant adverse events reported. The study was ethically approved, funded by Cutia Therapeutics, and supported by the Shanghai Skin Disease Hospital.

View this study on link.springer.com →

Discuss this study in the Community →

Research cited in this study

25 / 25 results

research Cell Therapy for Androgenetic Alopecia: Elixir or Trick?

June 2023 in “Stem cell reviews and reports”

Stem cell therapies could be a promising alternative for hair loss treatment, but more research is needed to understand their full potential and safety.

research Human Stem Cell Use in Androgenetic Alopecia: A Systematic Review

March 2023 in “Cells”

Stem cell treatments show promise for hair loss but need more research.

Protac Degraders of Androgen Receptor-Integrated Dissolving Microneedles for Androgenetic Alopecia and Recrudescence Treatment via Single Topical Administration

research Protac Degraders of Androgen Receptor-Integrated Dissolving Microneedles for Androgenetic Alopecia and Recrudescence Treatment via Single Topical Administration

December 2022 in “Small methods”

A new hair loss treatment using dissolving microneedles was found to speed up hair growth and was more effective than daily use of common hair growth drugs.

research Hair Follicle-Targeting Drug Delivery Strategies for the Management of Hair Follicle-Associated Disorders

14 citations , May 2022 in “Asian Journal of Pharmaceutical Sciences”

New hair follicle-targeting treatments show promise for hair disorders but need more research on safety and effectiveness.

research Efficacy Assessment for Low-Level Laser Therapy in the Treatment of Androgenetic Alopecia: A Real-World Study on 1383 Patients

1 citations , February 2022 in “Lasers in Medical Science”

Low-level laser therapy is about 80% effective in treating hair loss, with best results in males, those who use it for over a year, and those with scalp conditions like dandruff and rash.

Androgen Receptor-Mediated Paracrine Signaling Induces Regression of Blood Vessels in the Dermal Papilla in Androgenetic Alopecia

research Androgen Receptor-Mediated Paracrine Signaling Induces Regression of Blood Vessels in the Dermal Papilla in Androgenetic Alopecia

6 citations , January 2022 in “Journal of Investigative Dermatology”

Male pattern baldness is linked to higher levels of a certain receptor in the scalp, which leads to the shrinking of blood vessels and hair loss. Early treatment targeting this receptor could be more effective.

research Platelet-Rich Plasma in Melasma: A Systematic Review

5 citations , October 2021 in “Dermatologic Surgery”

Platelet-rich plasma (PRP) can significantly improve melasma, a skin pigmentation disorder, but may not add benefits when used with certain other treatments.

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 Hair Transplantation: Basic Overview

30 citations , April 2021 in “Journal of The American Academy of Dermatology”

Hair transplantation can effectively restore hair in balding areas.

research Evaluation of Adding Platelet-Rich Plasma to Combined Medical Therapy in Androgenetic Alopecia

5 citations , January 2021 in “Journal of Cosmetic Dermatology”

Adding platelet-rich plasma improves hair density and thickness in androgenetic alopecia.

Systematic Review of Platelet-Rich Plasma Use in Androgenetic Alopecia Compared with Minoxidil, Finasteride, and Adult Stem Cell-Based Therapy

research Systematic Review of Platelet-Rich Plasma Use in Androgenetic Alopecia Compared with Minoxidil, Finasteride, and Adult Stem Cell-Based Therapy

65 citations , April 2020 in “International Journal of Molecular Sciences”

PRP injections may be a safe, effective alternative for hair loss treatment compared to minoxidil and finasteride.

research Post-Finasteride Syndrome: Risks and Side Effects of Finasteride for Androgenetic Alopecia

15 citations , March 2020 in “Anais Brasileiros De Dermatologia”

Finasteride may cause lasting sexual, mental, and physical symptoms; use with caution.

research Post-Finasteride Syndrome: A Surmountable Challenge for Clinicians

30 citations , January 2020 in “Fertility and Sterility”

Finasteride can cause serious side effects in some men, needing more research for treatment.

research Minoxidil 1 mg Oral Versus Minoxidil 5% Topical Solution for the Treatment of Female-Pattern Hair Loss: A Randomized Clinical Trial

53 citations , August 2019 in “Journal of The American Academy of Dermatology”

Oral minoxidil and topical minoxidil 5% both effectively improve female-pattern hair loss with safe side effects.

research Minoxidil And Its Use In Hair Disorders: A Review

117 citations , August 2019 in “Drug Design Development and Therapy”

Minoxidil effectively treats hair loss, but use cautiously and monitor side effects.

research Low-Level Laser Therapy for the Treatment of Androgenic Alopecia: A Review

41 citations , December 2017 in “Lasers in Medical Science”

Low-Level Laser Therapy (LLLT) is a safe and effective treatment for common hair loss, but more research is needed to find the best power and wavelength for treatment.

research Evidence-Based Guideline for the Treatment of Androgenetic Alopecia in Women and Men – Short Version

145 citations , November 2017 in “Journal of The European Academy of Dermatology and Venereology”

Use minoxidil for hair loss treatment; assess results after 6 months.

research The Effectiveness of Treatments for Androgenetic Alopecia: A Systematic Review and Meta-Analysis

178 citations , April 2017 in “Journal of The American Academy of Dermatology”

Minoxidil, finasteride, and low-level laser light therapy effectively treat hair loss.

research Androgenetic Alopecia: A Review

153 citations , March 2017 in “Endocrine”

Male pattern baldness involves genetics, hormones, and needs better treatments.

Differential Expression Between Human Dermal Papilla Cells from Balding and Non-Balding Scalps Reveals New Candidate Genes for Androgenetic Alopecia

research Differential Expression Between Human Dermal Papilla Cells from Balding and Non-Balding Scalps Reveals New Candidate Genes for Androgenetic Alopecia

46 citations , April 2016 in “Journal of Investigative Dermatology”

New genes found linked to balding, may help develop future treatments.

Effects of a Novel Finasteride 0.25% Topical Solution on Scalp and Serum Dihydrotestosterone in Healthy Men with Androgenetic Alopecia

research Effects of a Novel Finasteride 0.25% Topical Solution on Scalp and Serum Dihydrotestosterone in Healthy Men with Androgenetic Alopecia

42 citations , December 2015 in “International Journal of Clinical Pharmacology and Therapeutics”

The 0.25% finasteride solution, when applied once a day, effectively reduces scalp DHT, potentially minimizing sexual side-effects linked to a systemic DHT reduction.

A Novel Finasteride 0.25% Topical Solution for Androgenetic Alopecia: Pharmacokinetics and Effects on Plasma Androgen Levels in Healthy Male Volunteers

research A Novel Finasteride 0.25% Topical Solution for Androgenetic Alopecia: Pharmacokinetics and Effects on Plasma Androgen Levels in Healthy Male Volunteers

50 citations , October 2014 in “International Journal of Clinical Pharmacology and Therapeutics”

New finasteride solution effectively reduces baldness-causing hormone, potentially with fewer side effects.

research The Biology of Hair Diversity

47 citations , January 2013 in “International Journal of Cosmetic Science”

Hair diversity is influenced by complex genetics and environmental factors, requiring more research for practical solutions.

research Prevalence of Androgenetic Alopecia in China: A Community-Based Study in Six Cities

126 citations , January 2010 in “British Journal of Dermatology”

Baldness is more common in Chinese men than women, increasing with age, and is influenced by genetics.

research Prevalence and Types of Androgenetic Alopecia in Shanghai, China: A Community-Based Study

66 citations , February 2009 in “British Journal of Dermatology”

Chinese men have lower AGA rates than Caucasians, with type III vertex most common; family history is important.

Similar Research

6 / 1000+ results

research Topical Finasteride for the Treatment of Male Androgenetic Alopecia and Female Pattern Hair Loss: A Review of the Current Literature

13 citations , June 2020 in “Journal of Dermatological Treatment”

Topical finasteride helps regrow hair and reduce hair loss in men and women.

research Finasteride

January 2022 in “Springer eBooks”

research A Novel Finasteride 0.25% Topical Solution for Androgenetic Alopecia: Pharmacokinetics and Effects on Plasma Androgen Levels in Healthy Male Volunteers

50 citations , October 2014 in “International Journal of Clinical Pharmacology and Therapeutics”

New finasteride solution effectively reduces baldness-causing hormone, potentially with fewer side effects.

A Randomized, Double-Blind Controlled Study of the Efficacy and Safety of Topical Solution of 0.25% Finasteride Admixed with 3% Minoxidil vs. 3% Minoxidil Solution in the Treatment of Male Androgenetic Alopecia

research A Randomized, Double-Blind Controlled Study of the Efficacy and Safety of Topical Solution of 0.25% Finasteride Admixed with 3% Minoxidil vs. 3% Minoxidil Solution in the Treatment of Male Androgenetic Alopecia

43 citations , July 2018 in “Journal of The European Academy of Dermatology and Venereology”

Finasteride and minoxidil mix works better for hair growth than minoxidil alone, with similar safety.

Randomized Controlled Trial on the Efficacy and Safety of the Combination Therapy of Topical 0.1% Finasteride and 5% Minoxidil in Male Androgenetic Alopecia

research Randomized Controlled Trial on the Efficacy and Safety of the Combination Therapy of Topical 0.1% Finasteride and 5% Minoxidil in Male Androgenetic Alopecia

April 2025 in “Archives of Dermatological Research”

The combination of finasteride and minoxidil is as safe and effective as minoxidil alone for improving hair growth in men.

research Androgenetic Alopecia: An Update Of Treatment Options

110 citations , August 2016 in “Drugs”

Minoxidil is the only FDA-approved topical drug for treating male or female pattern hair loss, and other medications like finasteride and dutasteride can also increase hair growth.