Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2025-12-24 @ 11:10 PM
NCT ID:
NCT03004469
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).
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT03004469
Study Brief:
Protocol Section:
NCT03004469