MedPath

A study to find out the effect of a new product for male pattern of hairloss

Phase 2
Completed
Registration Number
CTRI/2015/01/005477
Lead Sponsor
Curatio Healthcare I Pvt Ltd
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
42
Inclusion Criteria

a)Male patients of age between 18 to 50.

b)Presence of Androgenetic alopecia based on the Norwood Hamilton Scale grade 3, 4,5and 5A with vertex involvement.

c)Accepting not to use products with the same end benefit during the entire study duration.

d)For whom the Investigator considers that the compliance will be correct.

e)Cooperating, informed of the need and duration of the examinations, and ready to comply with protocol procedures.

f)Having signed a Consent Form and will be once informed orally and in writing of all information concerning the study procedures and study objectives.

Exclusion Criteria

a)Subjects having conditions like Alopecia areata, alopecia totalis, alopecia universalis and alopecia diffusa.

b)Scarring of the scalp or any other condition or disease of the scalp or hair, including diseases of the hair shaft and inability to discontinue use of hair weaving.

c)Volunteers with any cardiac abnormalities or ailments or abnormal blood pressure.

d)Use of the following during the 6 months prior to screening: Minoxidil (oral or topical)

e)Drugs with anti-androgenic properties (e.g., cyproterone acetate, spironolactone, ketoconazole, flutamide, bicalutamide).

f)Cimetidine cannot be used during the study but is not an excluded drug when used during the previous 6 months.

g)Drugs potentially causing hypertrichosis (e.g., cyclosporine, diazoxide, phenytoin psoralens) Anabolic steroids ,Lithium and phenothiazines.

h)Use of systemic steroids for more than 14 days within the past 2 months prior to enrolment in the study.

i)Use of isotretinoin, radiation to the scalp, or chemotherapy within the past year.

j)Known sensitivity to the investigational product.

k)Hypersensitivity to any cosmetic product, raw material.

l)Any clinically significant systemic or cutaneous disease, which may interfere with study treatments or procedures.

m)Subjects on any medical treatment either systemic or topical which may interfere with the performance of the study treatment (presently or in the past 1 month).

n)Subject in an exclusion period or participating in another similar cosmetic or therapeutic trial

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
© Copyright 2025. All Rights Reserved by MedPath