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

Recruitment & Eligibility

Status: Completed

Sex: Male

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.
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

Name	Time	Method
2.Hair growth rate	Day 30,Day 60,Day 90
3.Total hair density (n/cm2)	Day 30,Day 60,Day 90
1.Estimated percentage scalp hair loss	Day 30,Day 60,Day 90
4.Hair diameter	Day 30,Day 60,Day 90
5.Anagen/Telogen ratio( A/T)	Day 30,Day 60,Day 90
The primary endpoint of the study would be change in the following from Baseline to week 12 in treatment areas	Day 30,Day 60,Day 90

Secondary Outcome Measures

Name	Time	Method
The Secondary end-points of this study would be:	1.Local tolerability of the formulations as assessed by clinical examination of treatment areas, assessment parameters being Erythema, Scaling and Itching.

Trial Locations

Locations (1): Cutis Academy Of Cutaneous Sciences
🇮🇳
Bangalore, KARNATAKA, India
Cutis Academy Of Cutaneous Sciences
🇮🇳Bangalore, KARNATAKA, India
Dr Chandrashekar B
Principal investigator
9740091155
cutisclinic@gmail.com