Clinical trial NCT03004469: Study to Evaluate the Efficacy and Safety of P-3074 Topical Solution in the Treatment of Androgenetic Alopecia
Official title: A Multicentre, Randomized, Double-blind, Parallel-group, Controlled Study, to Assess the Efficacy and Safety of P-3074 Cutaneous Spray, Solution, in the Treatment of Male Pattern Baldness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Alopecia, Androgenetic
Lead sponsor: Polichem S.A.
Sponsor class: INDUSTRY
First posted: 2016-12-28
Enrollment: 458
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Primary outcomes:
measure: Adjusted Mean Change From Baseline in Hair Growth Assessed by Target Area Hair Count (TAHC) in the Vertex at Week 24
timeFrame: Baseline and Week 24
Secondary outcomes:
measure: Adjusted Mean Change From Baseline in Hair Growth Assessed by TAHC in the Vertex at Week 12
timeFrame: Baseline and Week 12
measure: Adjusted Mean Change From Baseline in Target Area Hair Width (TAHW) in the Vertex at Weeks 12 and 24
timeFrame: Baseline, Week 12 and Week 24
measure: Adjusted Mean Overall Male Hair Growth Questionnaire (MHGQ) Score as Assessed by the Participant at Weeks 12 and 24
timeFrame: Week 12 and Week 24
measure: Adjusted Mean Change From Baseline in Participants Hair Growth/Loss Assessed for the Vertex by Investigator at Weeks 12 and 24
timeFrame: Baseline, Week 12 and Week 24
measure: Adjusted Mean Change From Baseline in Participants Hair Growth/Loss at Weeks 12 and 24, Assessed for the Vertex by Blind Assessor
timeFrame: Baseline, Week 12 and Week 24
measure: Adjusted Mean International Index of Erectile Function (IIEF-2) Scores at Weeks 4, 8, 12 and 24
timeFrame: Weeks 4, 8, 12 and 24
measure: Local Tolerability as Assessed by Incidence Rate of Skin Irritation Event Via Severity Score for Skin Irritation Scale
timeFrame: Baseline to Week 24
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs
timeFrame: From the start of IMP up to 28 weeks
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Site #103
city: Brussels
country: Belgium
facility: Site #104
city: Brussel
country: Belgium
facility: Site #102
city: Gent
country: Belgium
facility: Site #101
city: Augsburg
country: Germany
facility: Site #211
city: Berlin
country: Germany
facility: Site #202
city: Berlin
country: Germany
facility: Site #212
city: Bochum
country: Germany
facility: Site #216
city: Dresden
country: Germany
facility: Site #210
city: Dresden
country: Germany
facility: Site #217
city: Dresden
country: Germany
facility: Site #221
city: Dusseldorf
country: Germany
facility: Site #203
city: Freiburg
country: Germany
facility: Site #204
city: Hamburg
country: Germany
facility: Site #206
city: Hamburg
country: Germany
facility: Site #214
city: Hamburg
country: Germany
facility: Site #218
city: Hannover
country: Germany
facility: Site #213
city: Karlsruhe
country: Germany
facility: Site #215
city: Lübeck
country: Germany
facility: Site #220
city: Münster
country: Germany
facility: Site #208
city: Potsdam
country: Germany
facility: Site #219
city: Schwerin
country: Germany
facility: Site #209
city: Wuppertal
country: Germany
facility: Site #201
city: Budapest
country: Hungary
facility: Site #303
city: Budapest
country: Hungary
facility: Site #309
city: Debrecen
country: Hungary
facility: Site #302
city: Satoraljaujhely
country: Hungary
facility: Site #308
city: Szolnok
country: Hungary
facility: Site #301
city: Szombathely
country: Hungary
facility: Site #307
city: Chelyabinsk
country: Russian Federation
facility: Site #401
city: Moscow
country: Russian Federation
facility: Site #402
city: Moscow
country: Russian Federation
facility: Site #407
city: Moscow
country: Russian Federation
facility: Site #411
city: Rostov
country: Russian Federation
facility: Site #409
city: Ryazan
country: Russian Federation
facility: Site #403
city: Saint-Petersburg
country: Russian Federation
facility: Site #406
city: Saint-Petersburg
country: Russian Federation
facility: Site #408
city: Yaroslavl
country: Russian Federation
facility: Site #410
city: Alicante
country: Spain
facility: Site #503
city: Barakaldo
country: Spain
facility: Site #505
city: Barcelona
country: Spain
facility: Site #502
city: Cordoba
country: Spain
facility: Site #507
city: Madrid
country: Spain
facility: Site #501
city: Madrid
country: Spain
facility: Site #504
city: Madrid
country: Spain
facility: Site #508
city: Pamplona
country: Spain
facility: Site #506
Study officials:
affiliation: Almirall, S.A.
name: Eric Massana, MD
role: STUDY_DIRECTOR
References: