| CTRI Number |
CTRI/2024/03/063477 [Registered on: 04/03/2024] Trial Registered Prospectively |
| Last Modified On: |
29/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare the efficacy and safety profile of topical minoxidil versus low dose oral minoxidil in patients with hairfall and hair thinning due to androgenetic alopecia in tertiary care teaching hospital,Haldwani,Uttarakhand. |
|
Scientific Title of Study
|
Comparative study of efficacy and safety profile of topical minoxidil 5% versus oral minoxidil 2.5 mg in patients with androgenetic alopecia in tertiary care teaching hospital,Haldwani,Uttarakhand. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Sally Rajkumari |
| Designation |
Post Graduate Student |
| Affiliation |
Government Medical College,Haldwani |
| Address |
Department Of Pharmacology, Government Medical College,Haldwani,Uttarakhand
Nainital
UTTARANCHAL
263139
India |
| Phone |
9625446628 |
| Fax |
|
| Email |
rk.sally@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhavana Srivastava |
| Designation |
Professor |
| Affiliation |
Government Medical College,Haldwani |
| Address |
Department Of Pharmacology, Government Medical College,Haldwani,Uttarakhand
Nainital
UTTARANCHAL
263139
India |
| Phone |
7895782824 |
| Fax |
|
| Email |
drsbhavana@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhavana Srivastava |
| Designation |
Professor |
| Affiliation |
Government Medical College,Haldwani |
| Address |
Department Of Pharmacology, Government Medical College,Haldwani,Uttarakhand
Nainital
UTTARANCHAL
263139
India |
| Phone |
7895782824 |
| Fax |
|
| Email |
drsbhavana@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pharmacology, Government Medical College, Haldwani |
|
|
Primary Sponsor
|
| Name |
Dr Sally Rajkumari |
| Address |
Department of Pharmacology, Government Medical College, Haldwani,Uttarakhand |
| 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 |
| Dr Sally Rajkumari |
Dr. Susheela Tiwari Government Hospital, Haldwani, Uttarakhand. |
Room number 24, Ground floor, Department of Dermatology
Nainital
UTTARANCHAL |
9625446628
rk.sally@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC GOVERNMENT MEDICAL COLLEGE HALDWANI |
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 |
| Intervention |
Oral minoxidil(2.5mg) |
Patients will be instructed to take minoxidil tablet 2.5 mg orally once daily every morning after breakfast for 6 months.
|
| Comparator Agent |
Topical minoxidil (5%) |
Patients will be instructed to apply 1ml of topical minoxidil 5% on the scalp with a dropper and massage their scalp softly once daily for 6 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients Of either sex with androgenetic alopecia ( Males- Stage 1 To 4 Of Hamilton-Norwood Scale; Females- Stage 1 And 2 Of Ludwig Scale).
2. Age 18 years and above.
3. Patients In good general health with no evidence of systemic illness.
4. Patients who will give written informed consent. |
|
| ExclusionCriteria |
| Details |
1. Pregnant And lactating women.
2. Children less than 18 years.
3. Patients with systemic disease( PCOD, cardiac patients, epileptic, cancer,etc.)
4. Patients with active scalp infection, seborrheic dermatitis.
5. Patients with alopecia other than androgenetic alopecia.
6. Patients with history of surgical correction of scalp hair.
7. Drug allergy. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the efficacy of topical minoxidil 5% versus oral minoxidil 2.5mg in patients with androgenetic alopecia.
|
Patients will be followed up at 0(baseline), 2 months, 4 months and 6 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the adverse effect of topical minoxidil & oral minoxidil. |
Patients will be followed up at 0(baseline), 2 months, 4 months & 6 months. |
|
|
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 2 |
|
Date of First Enrollment (India)
|
10/03/2024 |
| 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="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
There is scarcity of study regarding efficacy and safety profile of oral minoxidil in patients with androgenetic alopecia in Kumaon region. There are studies encouraging the use of oral minoxidil. Therefore, this study is conceptualized to compare the efficacy and safety profile of topical minoxidil 5% versus oral minoxidil 2.5mg in patients with Androgenetic Alopecia to be conducted in Department of Pharmacology, Government Medical College Haldwani & Department of Dermatology, Dr. Susheela Tiwari Government Hospital, Haldwani, Uttarakhand. |