| CTRI Number |
CTRI/2020/05/025390 [Registered on: 27/05/2020] Trial Registered Prospectively |
| Last Modified On: |
23/10/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Topical treatment regimens in male androgenetic alopecia |
|
Scientific Title of Study
|
Efficacy of Topical Minoxidil alone, Topical Finasteride alone and Topical Minoxidil - Finasteride combination in Male Androgenetic Alopecia - A Randomized Open-Label Study
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| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Apoorva V Bharadwaj |
| Designation |
PG First Year M.D Dermatology |
| Affiliation |
Lady Hardinge Medical College |
| Address |
Lady Hardinge Medical College, Dept of Dermatology and STD, Shaheed Bhagat Singh Marg, New Delhi
New Delhi
DELHI
110001
India |
| Phone |
9686257492 |
| Fax |
|
| Email |
avb185@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ram Chander |
| Designation |
Director Professor and Head |
| Affiliation |
Lady Hardinge Medical College |
| Address |
Lady Hardinge Medical College, Dept of Dermatology and STD, Shaheed Bhagat Singh Marg, New Delhi
New Delhi
DELHI
110001
India |
| Phone |
|
| Fax |
|
| Email |
chanderram41@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ram Chander |
| Designation |
Director Professor and Head |
| Affiliation |
Lady Hardinge Medical College |
| Address |
Lady Hardinge Medical College, Dept of Dermatology and STD, Shaheed Bhagat Singh Marg, New Delhi
New Delhi
DELHI
110001
India |
| Phone |
|
| Fax |
|
| Email |
chanderram41@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lady Hardinge Medical College, Dept of Dermatology and STD, Shaheed Bhagat Singh Marg, New Delhi - 110001 |
|
|
Primary Sponsor
|
| Name |
Lady Hardinge Medical College |
| Address |
Lady Hardinge Medical College, Dept of Dermatology and STD, Shaheed Bhagat Singh Marg, New Delhi - 110001 |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Apoorva V Bharadwaj |
Lady Hardinge Medical College |
Lady Hardinge Medical College, Dept of Dermatology and STD, Shaheed Bhagat Singh Marg, New Delhi - 110001
New Delhi
DELHI |
9686257492
avb185@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Lady Hardinge Medical College and Associated Hospitals |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L649||Androgenic alopecia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Topical Finasteride |
Patient is instructed to apply 1 ml of Topical Finasteride 0.25% solution, prepared in alcohol base, over affected area of scalp twice daily, for 6 months. |
| Comparator Agent |
Topical Minoxidil |
Patient is instructed to apply 1 ml of Topical Minoxidil 5% solution, prepared in alcohol base, over affected area of scalp twice daily, for 6 months. |
| Comparator Agent |
Topical Minoxidil-Finasteride combination |
Patient is instructed to apply 1 ml of Topical Minoxidil 5% + Finasteride 0.25% solution, prepared in alcohol base, over affected area of scalp twice daily, for 6 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Male |
| Details |
1. All new male patients with clinically diagnosed androgenetic alopecia of grade III or higher (Modified Norwood Hamilton classification) |
|
| ExclusionCriteria |
| Details |
1. Patients who have used any topical or systemic drugs in the past 6 months to promote hair growth
2. Patients with other scalp diseases that affect hair growth including seborrheic capitis
3. Patients with elevated levels of serum prostate specific antigen (PSA)
4. Patients with thyroid abnormality or vitamin D deficiency
5. Patients with history of continuing intake of following drugs – antihypertensives, antiepileptics, cytotoxic drugs, systemic corticosteroids, bronchodilators and vasodilators
|
|
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Method of Generating Random Sequence
|
Permuted block randomization, variable |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
Improvement in one or more of the following parameters in the three groups:
1. Mean Physician Assessment score (PAS)
2. Mean change in hair density from baseline
3. Mean change in number of terminal and vellus hair from baseline |
12 and 24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean Patient Satisfaction Scores (PSS) |
12 and 24 weeks |
| Proportion of patients experiencing side effects in the three groups |
12 and 24 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
29/05/2020 |
| 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="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
Modification(s)
|
Androgenetic alopecia (AGA) is the most common cause of hair loss in males and females and is characterized by a patterned hair loss. It can be psychosocially and emotionally very distressing to the patient leading him/her to feel unattractive and less confident. It has been therapeutically challenging to treat this condition. There are very limited atudies which have documented the efficacy of various treatment options. Therefore, this study aims to observe the efficacy of three topical treatment regimens that are routinely offered to patients with AGA presenting to our hospital, so as to identify the most effective treatment regimen available for these patients.
This is an open label randomized controlled trial where patients will be randomized by computer generated variable block size randomization. Patients will be allocated into three groups by sealed opaque envelope technique. Follow up period is 6 months and patients will be assessed at 12 and 24 weeks and the following observations will be made: 1. Mean physician assessment score (PAS) 2. Mean change in hair density 3. Mean change in number of terminal and vellus hair 4. Mean patient satisfaction score (PSS) 5. Proportion of patients experiencing side effects
Data will be collected and compiled in an excel sheet and will be analyzed statistically.
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