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Study to Evaluate the Efficacy and Safety of P-3074 Topical Solution in the Treatment of Androgenetic Alopecia

P

Polichem S.A.

Status and phase

Completed
Phase 3

Conditions

Alopecia, Androgenetic

Treatments

Drug: Finasteride Placebo
Drug: P-3074 Vehicle
Drug: P-3074
Drug: Finasteride

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

The purpose of this study is to confirm the clinical efficacy and the safety of P-3074 in participants with androgenetic alopecia.

Enrollment

458 patients

Sex

Male

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Written informed consent before starting any study related procedures;
  • Men 18 to 40 years of age;
  • Men with mild to moderate vertex male pattern hair loss according to a modified Norwood/Hamilton classification scale (III vertex, IV or V);
  • Participants willing to have a tattoo in the target area;
  • Outpatients;
  • Ability to comprehend the full nature and purpose of the study, including possible risks and side effects;
  • Ability to co-operate with the Investigator and to comply with the requirements of the entire study.

Exclusion criteria

  • Clinically relevant abnormal skin scalp findings which could interfere with the aim of the study; in particular, abrasion, actinic keratosis, inflammatory disorders or any other abnormality;
  • Participants who had had hair transplant surgery or hair weaving;
  • Clinically relevant abnormal laboratory values indicative of physical illness;
  • Ascertained or presumptive hypersensitivity to the active principle and/or formulations' ingredients; history of anaphylaxis to drugs or allergic reactions in general, which the Investigator considers may affect the outcome of the study;
  • History of local infections of skin and subcutaneous tissues of the head in the 3-months period before the trial inclusion;
  • Relevant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases, that may interfere with the aim of the study;
  • Suspicion of malignancy, including prostate cancer;
  • History of infertility or difficulty fathering children;
  • Participants who wish to conceive children during the study or whose sexual partner(s) is pregnant;
  • Participants with active seborrheic dermatitis;
  • History of varicocele;
  • Concurrent use of systemic corticosteroids, topical corticosteroids in the balding area studied, anabolic steroids, or over-the-counter "hair restorers";
  • Use of the following drugs with antiandrogenic properties within 6 months of study entry: flutamide, cyproterone acetate, estrogen, progesterone, cimetidine, spironolactone or ketoconazole;
  • Participants who had been treated with any of the following drugs within the past year: minoxidil (topical or oral), zidovudine, cyclosporine, diazoxide, phenytoin, systemic interferon, psoralens, streptomycin, penicillamine, benoxaprofen, tamoxifen, phenothiazines or cytotoxic agents;
  • Use of finasteride or dutasteride within previous 12 months;
  • Light or laser treatment of scalp within previous 3 months;
  • Participation in the evaluation of any drug for 3 months before this study, calculated from the first day of the month following the last visit of the previous study;
  • History of drug, alcohol [>2 drinks/day defined according to USDA Dietary Guidelines 2010], caffeine (>5 cups coffee/tea/day) or tobacco abuse (10 cigarettes/day).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

458 participants in 3 patient groups, including a placebo group

P-3074 + Finasteride Placebo
Experimental group
Description:
Participants received topical application of P-3074 contained finasteride 0.25% in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1 milligram (mg) tablet orally once daily for 24 weeks.
Treatment:
Drug: P-3074
Drug: Finasteride Placebo
P-3074 Vehicle + Finasteride Placebo
Placebo Comparator group
Description:
Participants received topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) and followed by placebo of finasteride 1 mg tablet orally once daily for 24 weeks.
Treatment:
Drug: P-3074 Vehicle
Drug: Finasteride Placebo
Oral Finasteride + P-3074 Vehicle
Active Comparator group
Description:
Participants received finasteride 1 mg tablet orally once daily followed by topical application of P-3074 vehicle in morning onto dry scalp only (up to 4 puffs) for the 24 weeks.
Treatment:
Drug: Finasteride
Drug: P-3074 Vehicle

Trial documents
4

Trial contacts and locations

46

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Data sourced from clinicaltrials.gov

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