Therapeutic Potential of Topical Latanoprost Acid in Hair Loss - Pilot, Proof-of-concept Study

NCT07412587 | Completed

• 1 other identifier: KB/148/2015
• Study Type: interventional
• Target: 29
• Locations: 0 countries
• Sites: N/A

Brief Summary

This pilot study evaluates the efficacy, safety, and tolerability of topical latanoprost acid in adult women with female pattern hair loss, with a minority of participants diagnosed with chronic telogen effluvium. In this randomized, double-blind, single-center, dose-ranging trial, participants receive latanoprost acid 0.01%, 0.05%, or 0.1% applied once daily for 6 months; a small vehicle group is included to support masking and assess tolerability. The primary outcome is the within-participant change in target-area hair count (hairs/cm²) from baseline to Month 6. Secondary and exploratory outcomes include follicular-unit distribution (percent of 1-, 2-, and 3-hair units), number of yellow dots, and patient-reported outcomes.

Conditions

Androgenetic Alopecia (AGA); Telogen Effluvium; Female Pattern Hair Loss, Androgenic Alopecia

Keywords

Female pattern hair loss (FPHL); latanoprost acid; Trichoscopy; Follicular unit remodeling

Outcome Measures

Primary Outcomes (1)

• Change from baseline in target-area hair count (TAHC)

  Within-participant absolute change in target-area hair count (TAHC, hairs/cm\^2) from baseline to Month 6, measured within a standardized 1 cm\^2 assessment field within the treated scalp region using standardized photography and trichoscopy.

  Baseline to Month 6

Secondary Outcomes (5)

• Change from baseline in hair-shaft thickness grade (0-3)

  Baseline to Month 6

• Change from baseline in follicular-unit (FU) arrangement (%FU1, %FU2, %FU3)

  Baseline to Month 6

• Change from baseline in number of yellow dots

  Baseline, Month 3, and Month 6

• Patient-reported outcomes (shedding, thickness, overall growth)

  Month 3 and Month 6

• Safety and tolerability: adverse events

  Up to 6 months (baseline through Month 6)

Other Outcomes (1)

• Percent change from baseline in target-area hair count (TAHC)

  Baseline to Month 6

Study Arms (4)

Vehicle cosmetic topical solution (placebo comparator)

PLACEBO COMPARATOR

Participants applied the vehicle topical solution (without latanoprost acid) once daily for 6 months to the androgen-dependent scalp area affected by thinning hair. The solution was administered using a dropper to distribute approximately 2-3 mL evenly, avoiding runoff, and participants were instructed not to wash the treated area for at least 8 hours after application. Concomitant hair-loss therapies were prohibited and usual hair-care routines were kept constant.

Other: Vehicle cosmetic topical solution (placebo comparator)

Latanoprost acid-containing cosmetic topical solution (0.01%)

EXPERIMENTAL

Participants applied latanoprost acid 0.01% in vehicle once daily for 6 months to the androgen-dependent scalp area affected by thinning hair. The solution was administered using a dropper to distribute approximately 2-3 mL evenly, avoiding runoff, and participants were instructed not to wash the treated area for at least 8 hours after application. Concomitant hair-loss therapies were prohibited and usual hair-care routines were kept constant.

Other: Latanoprost acid-containing cosmetic topical solution

Latanoprost acid-containing cosmetic topical solution (0.05%)

EXPERIMENTAL

Participants applied latanoprost acid 0.05% in vehicle once daily for 6 months to the androgen-dependent scalp area affected by thinning hair. The solution was administered using a dropper to distribute approximately 2-3 mL evenly, avoiding runoff, and participants were instructed not to wash the treated area for at least 8 hours after application. Concomitant hair-loss therapies were prohibited and usual hair-care routines were kept constant.

Other: Latanoprost acid-containing cosmetic topical solution

Latanoprost acid-containing cosmetic topical solution (0.1%)

EXPERIMENTAL

Participants applied latanoprost acid 0.1% in vehicle once daily for 6 months to the androgen-dependent scalp area affected by thinning hair. The solution was administered using a dropper to distribute approximately 2-3 mL evenly, avoiding runoff, and participants were instructed not to wash the treated area for at least 8 hours after application. Concomitant hair-loss therapies were prohibited and usual hair-care routines were kept constant.

Other: Latanoprost acid-containing cosmetic topical solution

Interventions

Latanoprost acid-containing cosmetic topical solution OTHER

Topical cosmetic solution containing latanoprost acid, evaluated at concentrations of 0.01%, 0.05%, and 0.1% in a vehicle formulation, with a matching vehicle-only cosmetic solution used as placebo comparator. The cosmetic solution was dispensed in identical, coded dropper bottles to maintain blinding. Participants applied the assigned cosmetic solution once daily for 6 months to the androgen-dependent scalp area affected by thinning hair, distributing approximately 2-3 mL evenly, avoiding runoff, and refraining from washing the treated area for at least 8 hours post-application. Use of concomitant hair-loss treatments was prohibited and usual hair-care routines were kept constant during the study.

Latanoprost acid-containing cosmetic topical solution (0.01%); Latanoprost acid-containing cosmetic topical solution (0.05%); Latanoprost acid-containing cosmetic topical solution (0.1%)

Vehicle cosmetic topical solution (placebo comparator) OTHER

Matching vehicle-only cosmetic topical solution without latanoprost acid. The product was dispensed in identical, coded dropper bottles to maintain blinding. Participants applied the vehicle cosmetic solution once daily for 6 months to the androgen-dependent scalp area affected by thinning hair, distributing approximately 2-3 mL evenly, avoiding runoff, and refraining from washing the treated area for at least 8 hours post-application. Concomitant hair-loss treatments were prohibited and usual hair-care routines were kept constant during the study.

Vehicle cosmetic topical solution (placebo comparator)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: Eligible participants were self-identified women aged 18-60 years.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female participants aged 18-60 years
• Diffuse scalp hair loss consistent with female pattern hair loss (FPHL), Ludwig grade I-III, or chronic telogen effluvium
• Willingness to comply with all study procedures

You may not qualify if:

• Recent use of other hair-growth treatments
• Active dermatologic conditions affecting the scalp (active scalp dermatoses)
• Significant uncontrolled medical conditions

Sponsors & Collaborators

• Medical University of Warsaw: lead

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Katarzyna A Koziak, Professor

  Medical University of Warsaw

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind masking was maintained by dispensing study product in identical-appearance dropper bottles. Each bottle carried a coded sticker label on the packaging, and treatment allocation was concealed by the code. Participants and investigators remained blinded through Month 6. The vehicle contained the same formulation without latanoprost acid to support masking.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel-group, randomized, double-blind, vehicle-controlled, dose-ranging pilot study at a single center. Eligible women were assigned to 1 of 4 arms (vehicle, or latanoprost acid 0.01%, 0.05%, or 0.1%) and treated for 6 months. Study medication was dispensed in identical, coded dropper bottles to maintain allocation concealment and blinding of participants and investigators through Month 6. The assigned solution was applied once daily to the androgen-dependent scalp area; efficacy evaluations were performed at standardized assessment points within the treated region using standardized clinical photography and trichoscopy, including a standardized 1 cm2 assessment field for repeatable target-area hair count and follicular-unit assessments.

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: February 17, 2026
• Study Start: July 8, 2015
• Primary Completion: July 8, 2016
• Study Completion: July 8, 2016
• Last Updated: February 17, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share