| CTRI Number |
CTRI/2024/12/077601 [Registered on: 03/12/2024] Trial Registered Prospectively |
| Last Modified On: |
02/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
How effective and safe is microneedling for acne scars? |
|
Scientific Title of Study
|
Efficacy and safety of microneedling in the
management of atrophic acne scars |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nilanjana Debnath |
| Designation |
Junior Resident |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University |
| Address |
Department of Dermatology and Venereology, 2nd floor, Institute of Medical Sciences, Banaras Hindu University campus, Ajagara
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
09962526261 |
| Fax |
|
| Email |
debnathnilanjana74@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Tulika Rai |
| Designation |
Professor |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University |
| Address |
Department of Dermatology and Venereology, Institute of Medical Sciences, Banaras Hindu University campus, Ajagara
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
09962526261 |
| Fax |
|
| Email |
raitulika1323@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Tulika Rai |
| Designation |
Professor |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University |
| Address |
Department of Dermatology and Venereology, Institute of Medical Sciences, Banaras Hindu University campus, Ajagara
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
09962526261 |
| Fax |
|
| Email |
raitulika1323@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Institute of Medical Science, Banaras Hindu University |
| Address |
Institute of Medical Science, Banaras Hindu University |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Nilanjana Debnath |
Institute of Medical Sciences, Banaras Hindu University |
Department of Dermatology and Venereology, 2nd floor, Institute of Medical Sciences, Banaras Hindu University campus, Ajagara
Varanasi
UTTAR PRADESH |
09962526261
debnathnilanjana74@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute of Medical Sciences, Banaras Hindu University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L70||Acne, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Microneedling |
Microneedling using handheld dermaroller device for atrophic acne scars will be done at 4 weekly intervals |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. All patients aged between 18- 40 years with atrophic acne scars voluntarily seeking treatment at I.M.S., B.H.U., Varanasi
2. Absence of active lesions of acne while on or off treatment.
3. Informed consent
|
|
| ExclusionCriteria |
| Details |
1. Pregnant and lactating women
2. Active lesions on treatment
3. Keloidal tendencies
4. Collagen vascular diseases
5. Bleeding disorders
6. Anticoagulant treatment
7. Active bacterial, fungal or viral infection over face
8. Any invasive acne scar treatment performed in the last 3 months.
9. History of photosensitivity
10. History of intake of oral isotretinoin, oral corticosteroids in the preceding 3 months
11. History of use of topical corticosteroids in the preceding 2 weeks
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Qualitative Goodman Baron scores, Quantitative Goodman Baron scores, % improvement by patient assessment |
baseline, 2 weeks, 6 weeks, 10 weeks, 14 weeks, 18 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| adverse effects |
baseline, 2 weeks, 6 weeks, 10 weeks, 14 weeks, 18 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
13/12/2024 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Patients with acne scar aged 18-40 years seeking treatment and providing consent will be included in study after ruling out exclusion criteria. The patients will undergo microneedling in 4 sessions at 4 weekly intervals and response will be assessed while looking out for adverse effects |