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

NCT03004469 | Completed Phase 3 Results

• 1 other identifier: PM1541
• Study Type: interventional
• Target: 458
• Locations: 5 countries
• Sites: 46

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

Outcome Measures

Primary Outcomes (1)

• Adjusted Mean Change From Baseline in Hair Growth Assessed by Target Area Hair Count (TAHC) in the Vertex at Week 24

  The change from baseline in the TAHC within a 1 cm\^2 (square centimeter) of baldness area at Week 24, were assessed by macro photographic techniques analysis. The Investigator selected a target area in the anterior leading edge of the vertex thinning area. A small dot tattoo was placed in the center of the circle of the clipped hairs. Using the tattoo as a reference point, the circular area was photographed and a 1 cm\^2 circular area within the target area was analysed. Change is the adjusted mean of Week 24 minus baseline.The analysis uses a covariance pattern model adjusted for treatment group, center, visit and treatment-by-visit interaction as fixed effects and baseline hair count as a covariate with an unstructured covariance structure.

  Baseline and Week 24

Secondary Outcomes (8)

• Adjusted Mean Change From Baseline in Hair Growth Assessed by TAHC in the Vertex at Week 12

  Baseline and Week 12

• Adjusted Mean Change From Baseline in Target Area Hair Width (TAHW) in the Vertex at Weeks 12 and 24

  Baseline, Week 12 and Week 24

• Adjusted Mean Overall Male Hair Growth Questionnaire (MHGQ) Score as Assessed by the Participant at Weeks 12 and 24

  Week 12 and Week 24

• Adjusted Mean Change From Baseline in Participants Hair Growth/Loss Assessed for the Vertex by Investigator at Weeks 12 and 24

  Baseline, Week 12 and Week 24

• Adjusted Mean Change From Baseline in Participants Hair Growth/Loss at Weeks 12 and 24, Assessed for the Vertex by Blind Assessor

  Baseline, Week 12 and Week 24

Study Arms (3)

P-3074 + Finasteride Placebo

EXPERIMENTAL

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.

Drug: P-3074; Drug: Finasteride Placebo

P-3074 Vehicle + Finasteride Placebo

PLACEBO COMPARATOR

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.

Drug: P-3074 Vehicle; Drug: Finasteride Placebo

Oral Finasteride + P-3074 Vehicle

ACTIVE COMPARATOR

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.

Drug: Finasteride; Drug: P-3074 Vehicle

Interventions

P-3074 DRUG

Also known as: finasteride topical solution

P-3074 + Finasteride Placebo

Finasteride DRUG

Also known as: Propecia

Oral Finasteride + P-3074 Vehicle

P-3074 Vehicle DRUG

Also known as: Vehicle of P-3074

Oral Finasteride + P-3074 Vehicle; P-3074 Vehicle + Finasteride Placebo

Finasteride Placebo DRUG

Also known as: Placebo of Finasteride

P-3074 + Finasteride Placebo; P-3074 Vehicle + Finasteride Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Polichem S.A.: lead

Study Sites (46)

Site #102

Brussels, Belgium

Location

Site #103

Brussels, Belgium

Location

Site #104

Brussels, Belgium

Location

Site #101

Ghent, Belgium

Location

Site #211

Augsburg, Germany

Location

Site #202

Berlin, Germany

Location

Site #212

Berlin, Germany

Location

Site #216

Bochum, Germany

Location

Site #210

Dresden, Germany

Location

Site #217

Dresden, Germany

Location

Site #221

Dresden, Germany

Location

Site #203

Düsseldorf, Germany

Location

Site #204

Freiburg im Breisgau, Germany

Location

Site #206

Hamburg, Germany

Location

Site #214

Hamburg, Germany

Location

Site #218

Hamburg, Germany

Location

Site #213

Hanover, Germany

Location

Site #215

Karlsruhe, Germany

Location

Site #220

Lübeck, Germany

Location

Site #208

Münster, Germany

Location

Site #219

Potsdam, Germany

Location

Site #209

Schwerin, Germany

Location

Site #201

Wuppertal, Germany

Location

Site #303

Budapest, Hungary

Location

Site #309

Budapest, Hungary

Location

Site #302

Debrecen, Hungary

Location

Site #308

Sátoraljaújhely, Hungary

Location

Site #301

Szolnok, Hungary

Location

Site #307

Szombathely, Hungary

Location

Site #401

Chelyabinsk, Russia

Location

Site #402

Moscow, Russia

Location

Site #407

Moscow, Russia

Location

Site #411

Moscow, Russia

Location

Site #409

Rostov, Russia

Location

Site #403

Ryazan, Russia

Location

Site #406

Saint Petersburg, Russia

Location

Site #408

Saint Petersburg, Russia

Location

Site #410

Yaroslavl, Russia

Location

Site #503

Alicante, Spain

Location

Site #505

Barakaldo, Spain

Location

Site #502

Barcelona, Spain

Location

Site #507

Córdoba, Spain

Location

Site #501

Madrid, Spain

Location

Site #504

Madrid, Spain

Location

Site #508

Madrid, Spain

Location

Site #506

Pamplona, Spain

Location

MeSH Terms

Conditions

Alopecia

Interventions

Finasteride

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Azasteroids; Steroids, Heterocyclic

Results Point of Contact

• Title: Francesco Scarci
• Organization: Polichem S.A.

francesco.scarci@almirall.com

+41 091 9864 005

Study Officials

• Eric Massana, MD

  Almirall, S.A.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2016
• First Posted: December 28, 2016
• Study Start: August 2, 2016
• Primary Completion: March 5, 2018
• Study Completion: March 5, 2018
• Last Updated: June 20, 2019
• Results First Posted: April 19, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

HU (6); BE (4); DE (19); ES (8); RU (9)