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

NCT ID: NCT03004469

Last Updated: 2019-06-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 458 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-02
• Study Completion Date: 2018-03-05

Brief Summary

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

Conditions

Alopecia, Androgenetic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

P-3074 + Finasteride Placebo

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.

Group Type: EXPERIMENTAL

P-3074

Intervention Type: DRUG

Finasteride Placebo

Intervention Type: DRUG

P-3074 Vehicle + Finasteride Placebo

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.

Group Type: PLACEBO_COMPARATOR

P-3074 Vehicle

Intervention Type: DRUG

Finasteride Placebo

Intervention Type: DRUG

Oral Finasteride + P-3074 Vehicle

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.

Group Type: ACTIVE_COMPARATOR

Finasteride

Intervention Type: DRUG

P-3074 Vehicle

Intervention Type: DRUG

Interventions

P-3074

Intervention Type: DRUG

Finasteride

Intervention Type: DRUG

P-3074 Vehicle

Intervention Type: DRUG

Finasteride Placebo

Intervention Type: DRUG

Other Intervention Names

finasteride topical solution; Propecia; Vehicle of P-3074; Placebo of Finasteride

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Polichem S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eric Massana, MD

Role: STUDY_DIRECTOR

Almirall, S.A.

Locations

Site #102

Brussels, , Belgium

Site #103

Brussels, , Belgium

Site #104

Brussels, , Belgium

Site #101

Ghent, , Belgium

Site #211

Augsburg, , Germany

Site #202

Berlin, , Germany

Site #212

Berlin, , Germany

Site #216

Bochum, , Germany

Site #210

Dresden, , Germany

Site #217

Dresden, , Germany

Site #221

Dresden, , Germany

Site #203

Düsseldorf, , Germany

Site #204

Freiburg im Breisgau, , Germany

Site #206

Hamburg, , Germany

Site #214

Hamburg, , Germany

Site #218

Hamburg, , Germany

Site #213

Hanover, , Germany

Site #215

Karlsruhe, , Germany

Site #220

Lübeck, , Germany

Site #208

Münster, , Germany

Site #219

Potsdam, , Germany

Site #209

Schwerin, , Germany

Site #201

Wuppertal, , Germany

Site #303

Budapest, , Hungary

Site #309

Budapest, , Hungary

Site #302

Debrecen, , Hungary

Site #308

Sátoraljaújhely, , Hungary

Site #301

Szolnok, , Hungary

Site #307

Szombathely, , Hungary

Site #401

Chelyabinsk, , Russia

Site #402

Moscow, , Russia

Site #407

Moscow, , Russia

Site #411

Moscow, , Russia

Site #409

Rostov, , Russia

Site #403

Ryazan, , Russia

Site #406

Saint Petersburg, , Russia

Site #408

Saint Petersburg, , Russia

Site #410

Yaroslavl, , Russia

Site #503

Alicante, , Spain

Site #505

Barakaldo, , Spain

Site #502

Barcelona, , Spain

Site #507

Córdoba, , Spain

Site #501

Madrid, , Spain

Site #504

Madrid, , Spain

Site #508

Madrid, , Spain

Site #506

Pamplona, , Spain

Countries

Belgium; Germany; Hungary; Russia; Spain

Provided Documents

Document Type: Study Protocol: Protocol Version 4 dated 8 Mar 2017

View Document

Document Type: Study Protocol: Non-substantial amendment 1 dated 8 Mar 17

View Document

Document Type: Statistical Analysis Plan: Statistical Analysis Plan dated 22 Jan 2018

View Document

Document Type: Statistical Analysis Plan: Statistical Analysis Plan Amendment 1 dated 23 Mar 2018

View Document

Other Identifiers

PM1541

Identifier Type: -

Identifier Source: org_study_id