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

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

NCT03004469

PM1541

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

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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