| CTRI Number |
CTRI/2009/091/001054 [Registered on: 01/04/2010] |
| Last Modified On: |
22/02/2013 |
| Post Graduate Thesis |
|
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
Modification(s)
|
A clinical trial to evaluate the efficacy of micronutrients in reducing hair loss, to increase hair growth and to improve scalp conditions in the androgenic alopecia. |
Scientific Title of Study
Modification(s)
|
A prospective, randomized, double blind, placebo controlled, two arm, parallel assignment study to evaluate clinical efficacy and safety of Hair growth Lotion + Tablet in the management of Androgenic alopecia (AGA). |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| MOPL-TRLT-1313 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Rachita Dhurat |
| Designation |
Professor and Head |
| Affiliation |
|
| Address |
Professor and Head,
Department of Dermatology TN Medical College BYL Nair Hospital Mumbai Central
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9870390057 |
| Fax |
02223012023 |
| Email |
rachitadhurat@yahoo.co.in |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Himanshu Tayade |
| Designation |
|
| Affiliation |
|
| Address |
Plot No A 303 Road No 32
Medical department Meyer Organics Wagle Industrial Estate Thane West
Thane
MAHARASHTRA
400604
India |
| Phone |
02581-7000 |
| Fax |
02225817102 |
| Email |
orathod@meyer.co.in |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Himanshu Tayade |
| Designation |
|
| Affiliation |
|
| Address |
Plot A303 Road No 32 Medical department,Meyer Organics, Wagle Industrial Estate Thane West
Thane
MAHARASHTRA
400604
India |
| Phone |
02581-7000 |
| Fax |
25817002 |
| Email |
orathod@meyer.co.in |
|
Source of Monetary or Material Support
Modification(s)
|
| Meyer Organics Pvt Ltd R and D Plot No A 303,Road No 32 Wagle Industrial Estate,Thane west,Maharashtra 400604 |
|
Primary Sponsor
Modification(s)
|
| Name |
Meyer Organics Pvt Ltd Thane |
| Address |
A 303 Road No 32 Wagle Industrial Estate Thane West |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rachita Dhurat |
Department of Dermatology, T.N.Medical College,B.Y.L. Nair Hospital, |
T.N.Medical College,B.Y.L.
Nair Hospital, Mumbai Central
Mumbai
MAHARASHTRA |
9870390057
0222223012023
rachitadhurat@yahoo.co.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, B.Y.L. Nair CH Hospital and T.N.Medical College,Mumbai Central,Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Reducing hair loss, to increase hair growth and to improve scalp conditions in the androgenic alopecia., |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Micronutrients Lotion and Tablet |
Gently massage the lotion (around 4ml- 5ml with the help of a dropper) on entire scalp every night,
Take two tablets by mouth each day with main meal.
Both preparations are for 4 to 6 months.
|
| Comparator Agent |
Placebo Lotion and Tablet |
Gently massage the lotion (around 4ml- 5ml with the help of a dropper) on entire scalp every night, Take two tablets by mouth each day with main meal. Both preparations are for 4 to 6 months. |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Day(s) |
| Age To |
50.00 Day(s) |
| Gender |
Male |
| Details |
Men aged 18 to 49 years with mild to moderate signs of AGA, which is classified in Modified Norwood-Hamilton Scale as stage 3V, 4 and 5.
Not be on a course of treatment, which affects the outcome of the study.
Individuals who are willing to give informed consent and willing to follow up.
No topical treatment for AGA for at least 6 weeks and no systemic treatment for at least 3 months prior to study initiation.
Willing to refrain from other AGA treatments during the course of the study.
Not have had hair chemically treated (including colored hair, permed hair, etc) within the month prior to the study.
|
|
| ExclusionCriteria |
| Details |
Coexistent androgenetic alopecia other than 3V, 4 and 5 stages of Norwood-Hamilton scale
Unwilling to maintain a consistent hair style and to avoid shaving of scalp hair throughout the course of the study.
Unable to comply with the protocol.
Patients who are on chronic oral steroids are not eligible for the study
Allergies to Investigational product.
Presence of irritated or visibly inflamed scalp.
Use of ultraviolet radiation, including tanning beds and PUVA therapy for treatment of acne, psoriasis, or any other skin condition within 2 months prior to study initiation.
Evidence of immunocompromise.
Advanced or poorly controlled diabetes.
Unstable cardiovascular disease.
Clinically significant medical or psychiatric disease as determined by the investigator.
Local infection (e.g. cellulitis, abscess) or systemic infection (e.g. pneumonia, septicemia) within 3 months prior to the first dose of investigational drug.
Those who have donated blood within a month of date of screening evaluation.
Drug or alcohol abuse.
|
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
Pre-numbered or coded identical Containers |
Blinding/Masking
Modification(s)
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
Primary Outcome Measures
Hair count by PTG (Phototrichograms) |
At baseline, 2,4 and 6 months |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
Secondary Outcome Measures
1.Self assessment by Patients
2.Physical examination of scalp
3.Hair density rating scale
4.Global assessment by investigator
5.Compliance and adverse effects
|
1.after 2 and 4 months
2.at baseline, after 1, 2, 3 and 4 months
3.after 2 and 4 months
4.After treatment completion
5.Compliance and adverse effects
|
|
Target Sample Size
Modification(s)
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
25/11/2009 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
25/11/2009 |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Study Design: A prospective, randomized, double blind, Placebo controlled, two arm, parallel assignment study. Sample size: 60 subjects (30 in each arm) Genders Eligible for Study: Male Study duration: 4 months (As per investigator, if desirable findings are not observed after 4 months, study can be extended to 6 months) Treatment: Subjects will be assigned to the study medications as per the randomization schedule. Outcome Measures: Primary Outcome Measures (at baseline and after 4 months) i. Hair count by PTG (Phototrichograms) Secondary Outcome Measures xi. Self assessment by Patients (questionnaire) (after 2 and 4 months) xii. Physical examination of scalp (at baseline, after 1, 2, 3 and 4 months) xiii. Hair density rating scale (after 2 and 4 months) xiv. Global assessment by investigator (After treatment completion) xv. Compliance and adverse effects Subject?s Eligibility Assessments: Inclusion criteria: ? Men aged 18 to 49 years with mild to moderate signs of AGA, which is classified in Modified Norwood-Hamilton Scale as stage 3V, 4 and 5. ? Not be on a course of treatment, which affects the outcome of the study. ? Individuals who are willing to give informed consent and willing to follow up. ? No topical treatment for AGA for at least 6 weeks and no systemic treatment for at least 3 months prior to study initiation. ? Willing to refrain from other AGA treatments during the course of the study. ? Not have had hair chemically treated (including colored hair, permed hair, etc) within the month prior to the study. Exclusion criteria: ? Coexistent androgenetic alopecia other than 3V, 4 and 5 stages of Norwood-Hamilton scale ? Unwilling to maintain a consistent hair style and to avoid shaving of scalp hair throughout the course of the study. ? Unable to comply with the protocol. ? Patients who are on chronic oral steroids are not eligible for the study ? Allergies to Investigational product. ? Presence of irritated or visibly inflamed scalp. ? Use of ultraviolet radiation, including tanning beds and PUVA therapy for treatment of acne, psoriasis, or any other skin condition within 2 months prior to study initiation. ? Evidence of immunocompromise. ? Advanced or poorly controlled diabetes. ? Unstable cardiovascular disease. ? Clinically significant medical or psychiatric disease as determined by the investigator. ? Local infection (e.g. cellulitis, abscess) or systemic infection (e.g. pneumonia, septicemia) within 3 months prior to the first dose of investigational drug. ? Those who have donated blood within a month of date of screening evaluation. ? Drug or alcohol abuse. Withdrawal criteria: ? Subject will be deemed as withdrawn from the study on request of participating individual. ? Repeated protocol criteria violation/deviation ? Serious adverse events/reaction where continuation of the study possess serious risk to the participants. Protocol deviation: Following criteria will be applicable to determine protocol deviation: ? Individual does not come within 7 days of his scheduled visit. ? Individual skips the medication twice daily. ? Individual takes other medication without consulting investigator. ? Individual does not bring study medication bottle at the time of visit. . Dropout: ? Individual is without study medication for more than 4 days consecutively in two week period. ? Individual does not report for the follow up within 8 days of his scheduled visit day, then he will be considered as a dropout |