| CTRI Number |
CTRI/2015/01/005477 [Registered on: 30/01/2015] Trial Registered Retrospectively |
| Last Modified On: |
28/12/2015 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A study to find out the effect of a new product for male pattern of hairloss |
|
Scientific Title of Study
|
A double blind, randomized, comparative, 12 week single centre clinical study to assess the bioavailability & efficacy of AAS with Minoxidil (5%) in Androgenetic Alopecia (AGA) cases |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AAS-AGA-001 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chandrashekar B |
| Designation |
Chief Dermatologist |
| Affiliation |
Principal Investigator |
| Address |
Cutis Academy Of Cutaneous Sciences
5/1, 4th Main Road, MRCR Layout,
Vijayanagar, Bengaluru- 560040 ,India
Bangalore
KARNATAKA
560040
India |
| Phone |
|
| Fax |
|
| Email |
cutisclinic@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chandrashekar B |
| Designation |
Chief Dermatologist |
| Affiliation |
Principal investigator |
| Address |
Cutis Academy Of Cutaneous Sciences
5/1, 4th Main Road, MRCR Layout,
Vijayanagar, Bengaluru- 560040 ,India
Bangalore
KARNATAKA
560040
India |
| Phone |
|
| Fax |
|
| Email |
cutisclinic@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prachi Parihar Saxena J |
| Designation |
Manager |
| Affiliation |
Clinical Trial in Charge |
| Address |
Curatio Healthcare (I) Pvt. Ltd.
25/13,Whites Road,
4th Floor, Mamatha Complex,
Royapettah,Chennai
Chennai
TAMIL NADU
600014
India |
| Phone |
04440152638 |
| Fax |
|
| Email |
prachi@curatiohealthcare.com |
|
|
Source of Monetary or Material Support
|
| Curatio Healthcare I Pvt Ltd |
|
|
Primary Sponsor
|
| Name |
Curatio Healthcare I Pvt Ltd |
| Address |
25/13,Whites Road,
4th Floor, Mamatha Complex,
Royapettah,Chennai - 600 014, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Chandrashekar B |
Cutis Academy Of Cutaneous Sciences |
5/1, 4th Main Road, MRCR Layout, Vijayanagar, Bengaluru- 560040 ,India
Bangalore
KARNATAKA |
9740091155
cutisclinic@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Lifetime Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Male subjects with Androgenetic Alopecia |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
AAS |
A combination of Minoxidil (5%) with green apple extraction,saw palmetto and Azelaic acid.The total duration of therapy for the product is 90 days(3 months) |
| Comparator Agent |
Minoxidil (5%) |
Apply 1-2 ml of Minoxidil 5% on the affected area of the scalp. Gently massage the solution to scalp for 10-20 seconds.Do not wash /rinse hair for at least 3 hours.
Total duration of therapy 90 days
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Male |
| Details |
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.
|
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The primary endpoint of the study would be change in the following from Baseline to week 12 in treatment areas
1.Estimated percentage scalp hair loss
2.Hair growth rate
3.Total hair density (n/cm2)
4.Hair diameter
5.Anagen/Telogen ratio( A/T)
|
Day 30,Day 60,Day 90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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.
2.Systemic safety measures as assessed by measuring vital signs like pulse, BP and temperature.
3.Adverse events
|
Day 30,Day 60,Day 90 |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
28/04/2014 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The main purpose of the study is to prove efficacy of the AAS in comparison with Minoxidil (5%) Subjects diagnosed with Androgenetic Alopecia are randomized to participate in the study. Informed consent will be obtained before undertaking any study related procedures. Diagnosis of Androgenetic Alopecia will be established for all patients by assessing different parameters. The subjects will visit their designated study site on following 5 different occasions: a) Screening -Visit 1 b) Baseline/Randomization-Visit 2 (Day 0), c) Visit 3 (Day 30), d) Visit 4 (Day 60) e) Visit 5 (Day 90) |