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Androgenetic Alopecia (AGA)NCT07412587

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

A study testing Latanoprost acid-containing cosmetic topical solution in people with Androgenetic Alopecia (AGA) and Telogen Effluvium, run by Medical University of Warsaw.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years, women only
What is being tested?
Latanoprost acid-containing cosmetic topical solution
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
29 participants
Where
No sites listed yet
Study dates
8 Jul 2015to 8 Jul 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

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

About this study

Official title: Investigation of the Effect of Cosmetic Products Containing Latanoprost Acid on Hair Condition in Women Aged 18-60 Years

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.

Read the detailed description

Detailed Description This single-center, randomized, double-blind, vehicle-controlled, dose-ranging pilot trial evaluated topical latanoprost acid in adult women with diffuse scalp hair loss consistent with female pattern hair loss (FPHL) or chronic telogen effluvium. Eligible participants were women aged 18-60 years with FPHL classified as Ludwig I-III or with chronic telogen effluvium. Key exclusion criteria included recent use of hair-growth treatments, active scalp dermatoses, or significant uncontrolled medical conditions. Forty participants were screened and 29 were enrolled.

Randomization and masking Participants were randomly assigned to one of four groups: vehicle (placebo) or latanoprost acid 0.01%, 0.05%, or 0.1%. Randomization was computer-generated. Allocation concealment was maintained using identical-appearance dropper bottles labeled with code numbers. Both participants and investigators were blinded to treatment assignment through Month 6, including during all outcome assessments. The placebo formulation consisted of the same vehicle without active latanoprost acid to ensure a comparable application experience across groups.

Intervention and study conduct Participants applied the assigned topical solution once daily for 6 months to the androgen-dependent scalp area affected by thinning. Participants were instructed to distribute the solution evenly using the dropper (2-3 mL per application as per instructions), avoid runoff, and refrain from washing the treated area for at least 8 hours after application. Usual hair-care routines (eg, shampoo and styling products) were kept constant during the study. Concomitant hair-loss therapies were prohibited throughout the treatment period.

Efficacy assessments and procedures Standardized clinical photography and trichoscopy were obtained at study visits, including baseline and follow-up assessments at Months 3 and 6. Outcome measurements were performed at standardized points within the treated region. A standardized 1 cm2 assessment field within the treated area was used to support consistent, repeatable measurements across visits. All visible hairs within the assessment field were counted to determine target-area hair count (TAHC, hairs/cm2). Trichoscopic outcomes included follicular-unit (FU) arrangement reported as the percentage of follicular units with a single hair (%FU1) and with 2 and 3 hairs (%FU2 and %FU3), as well as the number of yellow dots. Hair-shaft thickness was assessed on a 0-3 grading scale. Patient self-assessments were collected at Months 3 and 6 using a structured questionnaire addressing shedding, hair thickness/volume, and overall growth/satisfaction.

Endpoints: The prespecified primary endpoint was the within-subject absolute change in target-area hair count (ΔTAHC, hairs/cm^2) from baseline to Month 6 within the standardized assessment field. Secondary endpoints included change from baseline to Month 6 in hair-shaft thickness grade, follicular-unit (FU) arrangement (%FU1, %FU2, %FU3), and patient-reported outcomes collected using a structured questionnaire. Exploratory endpoints included dermoscopic markers, in particular change from baseline in the number of yellow dots assessed at Months 3 and 6.

Safety and tolerability Safety and tolerability were assessed at each visit through systematic adverse event collection, targeted scalp examination (including evaluation for erythema and irritation), and measurement of vital signs. Safety monitoring covered local scalp findings and any systemic effects during the 6-month treatment period.

Being tested
Latanoprost acid-containing cosmetic topical solution, Vehicle cosmetic topical solution (placebo comparator)
Keywords
Female pattern hair loss (FPHL), latanoprost acid, Trichoscopy, Follicular unit remodeling
Medical subject headings
Alopecia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Latanoprost acid-containing cosmetic topical solutionOther

    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.

  • 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.

Study groups in NCT07412587
Study groupRoleWhat they receive
Vehicle cosmetic topical solution (placebo comparator)Placebo comparatorParticipants 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.
Receives: Other: Vehicle cosmetic topical solution (placebo comparator)
Latanoprost acid-containing cosmetic topical solution (0.01%)ExperimentalParticipants 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.
Receives: Other: Latanoprost acid-containing cosmetic topical solution
Latanoprost acid-containing cosmetic topical solution (0.05%)ExperimentalParticipants 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.
Receives: Other: Latanoprost acid-containing cosmetic topical solution
Latanoprost acid-containing cosmetic topical solution (0.1%)ExperimentalParticipants 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.
Receives: Other: Latanoprost acid-containing cosmetic topical solution

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline to Month 6

Secondary outcomes (5)
  1. Change from baseline in hair-shaft thickness grade (0-3)

    Change from baseline to Month 6 in hair-shaft thickness grade assessed on standardized trichoscopic images obtained from standardized assessment points within the treated region. Scale title: Hair-shaft thickness grade scale. Scale range: 0 (minimum) to 3 (maximum). Higher scores indicate greater hair-shaft thickness.

    Measured: Baseline to Month 6

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

    Change from baseline to Month 6 in follicular-unit arrangement assessed by trichoscopy as the percentage of follicular units with single hair (%FU1) and with 2 hairs (%FU2) and 3 hairs (%FU3) within standardized assessment points in the treated region.

    Measured: Baseline to Month 6

  3. Change from baseline in number of yellow dots

    Change from baseline in the number of yellow dots assessed by trichoscopy within standardized assessment points in the treated region; evaluated at Month 3 and Month 6.

    Measured: Baseline, Month 3, and Month 6

  4. Patient-reported outcomes (shedding, thickness, overall growth)

    Patient self-assessment of shedding, perceived hair thickness, and overall hair growth collected using a structured questionnaire.

    Measured: Month 3 and Month 6

  5. Safety and tolerability: adverse events

    Incidence and severity of adverse events (AEs) collected at study visits through systematic adverse event monitoring during the 6-month treatment period.

    Measured: Up to 6 months (baseline through Month 6)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2026
  2. Study start8 Jul 2015
  3. Primary completion8 Jul 2016
  4. Study completion8 Jul 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07412587
Sponsor's protocol ID
KB/148/2015
Status last verified
Jan 2026
First submitted
2 Feb 2026
Last updated
17 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data (IPD) will not be shared with other researchers. IPD will not be made available to protect participant privacy and confidentiality and due to the small sample size, which may increase the risk of re-identification. Only aggregate, de-identified results will be reported.

Publications

  • Rakowska A, Dutkiewicz M, Zegrocka-Stendel O, Dymkowska D, Huszcza G, Wierzbicki M, Walczak J, Rudnicka L, Koziak K. Topical latanoprost acid for female androgenetic alopecia: a pilot proof-of-concept trial with mechanistic evidence of prostaglandin F2alpha receptor activation. Pharmacol Rep. 2026 Aug;78(4):1236-1249. doi: 10.1007/s43440-026-00876-0. Epub 2026 Jul 10.

    PubMed 42430069

Questions about this trial

What is this clinical trial studying?

A study testing Latanoprost acid-containing cosmetic topical solution in people with Androgenetic Alopecia (AGA) and Telogen Effluvium, run by Medical University of Warsaw.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in target-area hair count (TAHC) (time frame: Baseline to Month 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07412587, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.

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