Actively Recruiting

Phase 3
Age: 18Years +
FEMALE
ID05888922

International Phase III, Multi Center, Randomized, Double Blind, Placebo and Active Controlled Clinical Trial to Evaluate the Efficacy and Safety of Oral Minoxidil 1 mg in Female Patients With Androgenetic Alopecia

Led by Industrial Farmacéutica Cantabria, S.A. · Updated on 2026-05-12

520

Participants Needed

13

Research Sites

4 weeks

Total Duration

On this page

Sponsors

I

Industrial Farmacéutica Cantabria, S.A.

Lead Sponsor

B

Bioskin GmbH

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating oral minoxidil 1 mg for women with androgenetic alopecia, a type of hormone-related hair loss. This phase III clinical trial aims to compare the effectiveness of oral minoxidil 1 mg to a 2% topical minoxidil solution and placebo, while also monitoring safety. Approximately 520 adult female patients with this condition will participate across multiple centers in Europe. Participants will be randomly assigned to one of three groups: oral minoxidil 1 mg once daily plus a topical vehicle solution twice daily; an oral placebo once daily plus topical 2% minoxidil solution twice daily; or oral placebo once daily plus a topical vehicle solution twice daily. The treatment period lasts six months, with doses taken mainly at home, and includes a screening period and a four-week follow-up. During the 36-week study, patients will visit the clinic five times for examinations and receive two safety phone calls. Assessments include hair photos to measure density, scalp hair growth evaluations, vital signs, blood and urine tests, ECGs, and checks for excessive hair growth. Participants will track daily side effects, medication changes, and pregnancy tests if applicable. The main outcome is the change in hair count in the target scalp area from baseline to week 24.

CONDITIONS

Brief Title

Evaluation of Efficacy and Safety of Oral Minoxidil 1 mg in Female Androgenetic Alopecia

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female patients aged 18 years or older in generally good health with no history of cardiovascular or significant diseases
  • Diagnosed with female androgenetic alopecia showing decreased hair density (Sinclair Scale 2-4) in the centroparietal scalp area
  • Hair color provides sufficient contrast with scalp confirmed by TrichoLab Virtual Tattoo technology
  • Signed informed consent indicating full understanding of the trial
  • Negative pregnancy tests at screening and baseline for women of childbearing potential
  • Women of childbearing potential must be permanently sterile or use highly effective birth control during the trial and for 2 weeks after
  • Willing to keep the same hairstyle and hair care routine throughout the trial
  • Willing to maintain consistent facial and body hair removal habits before each visit
  • Able and willing to comply with visits, treatment, lab tests, and daily electronic diary recordings using own device and internet
Not Eligible

You will not qualify if you...

  • Known allergy or hypersensitivity to minoxidil or any product components
  • Pregnancy, desire for pregnancy, or breastfeeding during the trial
  • Diagnosed treated or untreated hypertension (blood pressure >150/95 mmHg) or history of cardiovascular diseases
  • Scalp dermatological disorders in the target area that may interfere with treatment or assessments
  • History of hair transplant surgery or hair extensions within 6 months before baseline
  • Abnormal lab or ECG findings indicating illness at screening
  • History of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, hematological, endocrine, or neurological diseases interfering with trial aims
  • Recent use of topical scalp treatments, hormone therapies, or hair growth products within specified timeframes before baseline
  • Recent use of systemic medications affecting hair growth or cardiovascular system within specified timeframes
  • Participation in other investigational drug studies within 30 days or 5 half-lives prior to baseline
  • History of drug or alcohol dependency
  • Likely non-compliance or inability to give informed consent
  • Close affiliation with investigator or sponsor employees
  • Institutionalized due to legal or regulatory order

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - Up to approximately 8 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 6 months

Participants receive oral tablets and topical solution daily for 6 months to treat androgenetic alopecia.

5 clinical trial center visits and 2 safety phone calls during treatment

Follow-up

Duration - 4 weeks

Participants are monitored for safety and efficacy for 4 weeks after treatment ends.

1 clinical trial center visit (in-person)

Trial Site Locations

Total: 13 locations

1

Fachklinik Bad Bentheim Klinisches Studienzentrum

Bad Bentheim, Germany

Actively Recruiting

2

CRC - Charité Universitätsmedizin Berlin Clinical Research Center for Hair and Skin Science

Berlin, Germany

Actively Recruiting

3

emovis by Futuremeds GmbH

Berlin, Germany

Actively Recruiting

4

Rosenpark Reasearch GmbH

Darmstadt, Germany

Not Yet Recruiting

5

Privatpraxis Dr. Hilton & Partner

Düsseldorf, Germany

Terminated

6

Klinik für Dermatologie, Venerologie und Allergologie - Universitätsmedizin Frankfurt

Frankfurt, Germany

Actively Recruiting

7

Dermaticum -Dr. med. Mario Bittar und Kollegen

Freiburg im Breisgau, Germany

Actively Recruiting

8

Eurofins bioskin - Research Center Dermatology

Hamburg, Germany

Actively Recruiting

9

Klinische Forschung Karlsruhe GmbH

Karlsruhe, Germany

Actively Recruiting

10

Siteworks - Prüfzentrum Lohne

Löhne, Germany

Active, Not Recruiting

11

Zentrale Studienkoordination für innovative Dermatologie (ZiD) Klinik für Hautkrankheiten Universitätsklinikum Münster (UKM)

Münster, Germany

Withdrawn

12

Haut-und Lasercentrum - Dr. Tanja Fischer und Kollegen

Potsdam, Germany

Actively Recruiting

13

TRIDERM Study Site Dermatological practice Dr. Leitz and colleagues

Stuttgart, Germany

Actively Recruiting

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Research Team

A

Ana López-Ballesteros

J

Juan José Andrés Lencina

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Published Research Related To This Trial

Female Pattern Hair Loss and Androgen Excess: A Report From the Multidisciplinary Androgen Excess and PCOS Committee.

Enrico Carmina, Ricardo Azziz, Wilma Bergfeld...

https://pubmed.ncbi.nlm.nih.gov/30785992

HrQoL in hair loss-affected patients with alopecia areata, androgenetic alopecia and telogen effluvium: the role of personality traits and psychosocial anxiety.

P M Russo, E Fino, C Mancini...

https://pubmed.ncbi.nlm.nih.gov/30394586

Human hair follicles contain two forms of ATP-sensitive potassium channels, only one of which is sensitive to minoxidil.

Katie Shorter, Nilofer P Farjo, Steven M Picksley...

https://pubmed.ncbi.nlm.nih.gov/18258787