| CTRI Number |
CTRI/2020/12/030007 [Registered on: 23/12/2020] Trial Registered Prospectively |
| Last Modified On: |
17/12/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Other (Specify) [Low level light therapy] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Low Level Light
therapy and topical 5% Minoxidil in the management of male patterned baldness |
|
Scientific Title of Study
|
Randomised controlled trial to study the efficacy and safety of low level light therapy and topical 5% minoxidil in the management of androgenetic alopecia in males |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shekhar Neema |
| Designation |
Assoc Prof, Dermatology |
| Affiliation |
Armed Forces Medical College, Pune |
| Address |
Room no. 3
Department of Dermatology
Armed Forces Medical College
Pune
MAHARASHTRA
411040
India |
| Phone |
|
| Fax |
|
| Email |
shekharadvait@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shekhar Neema |
| Designation |
Assoc prof, Dermatology |
| Affiliation |
Armed Forces Medical College |
| Address |
Department of Dermatology
Armed Forces Medical College
Pune
MAHARASHTRA
411040
India |
| Phone |
|
| Fax |
|
| Email |
shekharadvait@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
S Radhakrishnan |
| Designation |
Prof and HOD |
| Affiliation |
Armed Forces Medical College |
| Address |
Department of Dermatology
Armed Forces Medical College
Pune
MAHARASHTRA
411040
India |
| Phone |
9449275068 |
| Fax |
|
| Email |
drsrkskin@gmail.com |
|
|
Source of Monetary or Material Support
|
| Armed Forces Medical Research Committee (AFMRC) - DRDO |
|
|
Primary Sponsor
|
| Name |
AFMRC |
| Address |
IHQ of MoD |
| Type of Sponsor |
Government funding agency |
|
|
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 |
| Sunmeet Sandhu |
AFMC, Pune |
Wanowarie, Sholapur road, Pune
Pune
MAHARASHTRA |
9830032821
sunmeet.sandhu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Armed Forces medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L649||Androgenic alopecia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
5% Minoxidil |
1 ml twice a day for 6 months |
| Intervention |
Low level light therapy |
Three sessions per week - 20 mins each for 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Male |
| Details |
Grade 2-5 Norwood - Hamilton classification |
|
| ExclusionCriteria |
| Details |
1. use of finasteride or dutasteride within last 6 months
2. Topical hair growth agents within last 3 months
3, History of hair transplantation
4. Systemic disease affecting scalp |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 50% improvement based on likert scale |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| patient satisfaction score 2 or 3 (moderate satisfaction to satisfaction) |
6 months |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/01/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not published yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Androgenetic alopecia is the most common form of alopecia in males. The treatment modalities for treatment of androgenetic alopecia are minoxidil and finasteride. Low level light therapy is new FDA approved treatment for management of androgenetic alopecia. We want to compare efficacy of LLLT with 5% minoxidil for its treatment. |