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

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ClinicalTrials.gov Identifier: NCT03004469
Recruitment Status : Completed
First Posted : December 28, 2016
Last Update Posted : March 7, 2018
Sponsor:
Information provided by (Responsible Party):
Polichem S.A.

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

Condition or disease Intervention/treatment Phase
Alopecia, Androgenetic Drug: P-3074 Drug: Finasteride Drug: Vehicle Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 459 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : August 2, 2016
Actual Primary Completion Date : January 31, 2018
Actual Study Completion Date : March 5, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Finasteride

Arm Intervention/treatment
Experimental: P-3074
finasteride 0.25% topical solution
Drug: P-3074
Other Name: finasteride topical solution

Placebo Comparator: vehicle of P-3074
vehicle topical solution
Drug: Vehicle
Other Name: Vehicle of P-3074

Active Comparator: finasteride 1 mg
oral finasteride
Drug: Finasteride
Other Name: Propecia




Primary Outcome Measures :
  1. Hair growth assessed by Target Area Hair Count (TAHC) in the vertex [ Time Frame: Baseline - 24 weeks ]


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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);
  • Patients 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;
  • Patients 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;
  • Patients who wish to conceive children during the study or whose sexual partner(s) is pregnant;
  • Patients 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;
  • Patients 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03004469


  Show 46 Study Locations
Sponsors and Collaborators
Polichem S.A.
Investigators
Study Director: Maurizio Caserini, MD Polichem SA

Responsible Party: Polichem S.A.
ClinicalTrials.gov Identifier: NCT03004469     History of Changes
Other Study ID Numbers: PM1541
First Posted: December 28, 2016    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Pharmaceutical Solutions
Finasteride
5-alpha Reductase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Urological Agents