| CTRI Number |
CTRI/2022/12/048063 [Registered on: 13/12/2022] Trial Registered Prospectively |
| Last Modified On: |
12/12/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Topical Methotrexate in the Treatment of patches of Hair Fall |
|
Scientific Title of Study
|
Comparitive Evaluation of Efficacy, Safety,and Cost Effectiveness of Topical Betamethasone with Tretinoin VS Methotrexate with Tretinoin in Patients of Alopecia Areata: A Prospective Randomised Double Blind Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vaibhav Vivek Kalgaonkar |
| Designation |
MD Pharmacology 1st year Resident |
| Affiliation |
Gajra Raja Medical College Gwalior Madhya Pradesh |
| Address |
3rd Floor 123 Pnachvati Vastra Nagar Roshni Ghar Lashkar Gwalior Madhya Pradesh
Gwalior
MADHYA PRADESH
474008
India |
| Phone |
9999742583 |
| Fax |
|
| Email |
vaibhav.kalgaonkar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Saroj Kothari |
| Designation |
Professor and Head Pharmacology |
| Affiliation |
Gajra Raja Medical College Gwalior Madhya Pradesh |
| Address |
Department of Pharmacology
G R Medical College Gwalior
Gwalior
MADHYA PRADESH
474009
India |
| Phone |
9827322002 |
| Fax |
|
| Email |
saroj.kothari@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vaibhav Vivek Kalgaonkar |
| Designation |
MD Pharmacology 1st year Resident |
| Affiliation |
Gajra Raja Medical College Gwalior Madhya Pradesh |
| Address |
3rd Floor 123 Pnachvati Vastra Nagar Roshni Ghar Lashkar Gwalior Madhya Pradesh
Gwalior
MADHYA PRADESH
474008
India |
| Phone |
9999742583 |
| Fax |
|
| Email |
vaibhav.kalgaonkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| GR Medical College
Veer Savarkar Marg
Gwalior – 474009
Madhya Pradesh
India |
|
|
Primary Sponsor
|
| Name |
Vaibhav Vivek Kalgaonkar |
| Address |
3rd Floor 123 Panchvati Vastra Nagar Roshni Ghar Lashkar Gwalior Madhya Pradesh |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Vaibhav Kalgaonkar |
J A Group of Hospitals |
Room no.27 Dermatology OPD of Jaya Arogya Hospital
Lashkar Gwalior Madhya Pradesh 474009
Gwalior
MADHYA PRADESH |
9999742583
vaibhav.kalgaonkar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Jaya Aarogya Hospital of GRMC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L638||Other alopecia areata, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Topical Betamethasone 0.05% with Topical Tretinoin 0.025% |
Patients will be asked to apply Topical Betamethasone 0.025% once every 24hours in the morning for 3 months with Topical Tretinoin 0.025% once every 24 hours in the evening for 3 months over the affected area |
| Comparator Agent |
Topical Methotrexate 1% with Topical Tretinoin 0.025% |
patients of other group will be asked to apply Topical Methotrexate 1% once every 24hours in the morning for 3 months with Topical Tretinoin 0.025% once every 24 hours in the evening for 3 months over the affected part |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients of Alopecia Areata of at least 2 months duration
Patients having patches in 1-3 numbers over the scalp.
Patients who are willing to take part in the study with signed and written informed consent.
Patients could be of both male and female.
All patients who are 18 years and above of age
Patient must be medically stable.
Patient must have active mobile number. |
|
| ExclusionCriteria |
| Details |
Patients who are not willing to sign in after informed consent.
Pregnant, breast feeding, child bearing age using contraception.
Patient with Alopecia Totalis and Alopecia Universalis
Patient with a K/C/O any Autoimmune conditions like SLE, Thyroid disorder, Vitiligo, etc.
Patient receiving systemic treatment relevant to alopecia areata within 3 months of enrollment.
Patient receiving Topical treatment relevant to Alopecia areata within 2 months
Patient with any Fungal infection of scalp
Patient with dermatological conditions affecting skin other than Alopecia Areata.
Patient with psychiatric illness or psychological state interfering with compliance
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To Observe the Effect of Test Drugs on Hair Regrowth in the patients of Alopecia Areata using Alopecia Grading Scale (AGS) and Alopecia Regrowth Score (RGS).
To compare the efficacy between both the groups
|
Baseline on the day of enrollment
1st,2nd and 3rd month
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To check any adverse effects of the the test drugs |
End of 1st, 2nd and 3rd month |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
14/12/2022 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is an interventional study being done on subjects of Alopecia Areata. The Study involves comparison between effectiveness of Topical application of Methotrexate in combination with Topical Tretinoin versus Topical Betamethasone with Topical Tretinoin. The study duration will be for one year and the estimated sample size will be 80 such that 40 will be in each group. The results will be compared as per the hair regrowth percentage status as compared with the initial affected area. |