Phase 3
N=458
Study to Evaluate the Efficacy and Safety of P-3074 Topical Solution in the Treatment of Androgenetic Alopecia
Alopecia, Androgenetic
Bottom Line
View on ClinicalTrials.gov: NCT03004469 ↗Enrolled (actual)
458
Serious AEs
2.2%
Results posted
Apr 2019
Primary outcome: Primary: Adjusted Mean Change From Baseline in Hair Growth Assessed by Target Area Hair Count (TAHC) in the Vertex at Week 24 — 20.2; 6.7; 21.1 Hairs — p=<.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- P-3074 (Drug); Finasteride (Drug); P-3074 Vehicle (Drug); Finasteride Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Polichem S.A.
- Primary completion
- Mar 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adjusted Mean Change From Baseline in Hair Growth Assessed by Target Area Hair Count (TAHC) in the Vertex at Week 24 |
20.2; 6.7; 21.1 | <.001 sig |
| SECONDARY Adjusted Mean Change From Baseline in Hair Growth Assessed by TAHC in the Vertex at Week 12 |
20.4; 7.6; 22.5 | <.001 sig |
| SECONDARY Adjusted Mean Change From Baseline in Target Area Hair Width (TAHW) in the Vertex at Weeks 12 and 24 |
-1.1231; -0.7207; -0.6938; -0.8052; -1.5289; 0.7163 | 0.322 |
| SECONDARY Adjusted Mean Overall Male Hair Growth Questionnaire (MHGQ) Score as Assessed by the Participant at Weeks 12 and 24 |
2.9; 3.0; 2.8; 2.8; 3.0; 2.9 | 0.569 |
| SECONDARY Adjusted Mean Change From Baseline in Participants Hair Growth/Loss Assessed for the Vertex by Investigator at Weeks 12 and 24 |
0.5; 0.4; 0.5; 0.8; 0.3; 0.7 | 0.708 |
| SECONDARY Adjusted Mean Change From Baseline in Participants Hair Growth/Loss at Weeks 12 and 24, Assessed for the Vertex by Blind Assessor |
0.0; 0.2; 0.2; 0.2; 0.1; 0.3 | 0.179 |
| SECONDARY Adjusted Mean International Index of Erectile Function (IIEF-2) Scores at Weeks 4, 8, 12 and 24 |
24.5; 26.2; 23.5; 24.3; 24.9; 24.4 | 0.103 |
| SECONDARY Local Tolerability as Assessed by Incidence Rate of Skin Irritation Event Via Severity Score for Skin Irritation Scale |
0.340; 0.245; 0.661; 0.368; 0.463; 0.755 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs |
75; 76; 41; 4; 5; 1 | — |
Summary
The purpose of this study is to confirm the clinical efficacy and the safety of P-3074 in participants with androgenetic alopecia.
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).
Data sourced from ClinicalTrials.gov (NCT03004469). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.