| CTRI Number |
CTRI/2025/04/083956 [Registered on: 02/04/2025] Trial Registered Prospectively |
| Last Modified On: |
02/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Medical device with serum] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to check whether Dermapen 4™ microneedling device with MG-BL serum reduces melasma |
|
Scientific Title of Study
|
A full-face baseline controlled study to evaluate the efficacy of Dermapen 4™ microneedling device
in conjunction with MG-BL serum for melasma treatment over 12 weeks |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SKIN/EMMS/2025-03 Version: 1.0 Dated: 11 Mar 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mukta Sachdev |
| Designation |
Principal Investigator |
| Affiliation |
MS Clinical Research Pvt. Ltd. |
| Address |
#327, Room number 2, Ground Floor, Admin Block,
1st Main Road, Cambridge Layout,
Ulsoor,
Bangalore
KARNATAKA
560008
India |
| Phone |
8040917253 |
| Fax |
|
| Email |
mukta.sachdev@msclinical.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ritambhara |
| Designation |
Director- Business and Operations |
| Affiliation |
MS Clinical Research Pvt. Ltd. |
| Address |
#327, Room no 1, Ground floor,
Admin Block
1st Main Road, Cambridge Layout,
Ulsoor,
Bangalore
KARNATAKA
560008
India |
| Phone |
8040917253 |
| Fax |
|
| Email |
ritambhara@msclinical.com |
|
Details of Contact Person
Public Query
|
| Name |
Sudhanthiran S |
| Designation |
Manager- Techno Commercial |
| Affiliation |
MS Clinical Research Pvt. Ltd. |
| Address |
324, 2nd Floor, room no 2,
1st Main Road, Cambridge Layout,
Ulsoor,
Bangalore
KARNATAKA
560008
India |
| Phone |
8040917253 |
| Fax |
|
| Email |
sudhan@msclinical.com |
|
|
Source of Monetary or Material Support
|
| Equipmed USA LLC, 4695 Macarthur Crt, Newport Beach CAL 92660, United States. |
|
|
Primary Sponsor
|
| Name |
Equipmed USA LLC. |
| Address |
4695 Macarthur Crt, Newport Beach CAL 92660, United States |
| Type of Sponsor |
Other [Medical Device Company] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mukta Sachdev |
MS Clinical Research Pvt. Ltd, |
Department of Skin Sciences,
#324, room number 2, Second Floor, 1st Main Road, Cambridge Layout, Ulsoor,
Bangalore
KARNATAKA |
08040917253
mukta.sachdev@msclinical.com |
| Dr Mukta Sachdev |
MS Clinical Research Pvt. Ltd, |
327/15, Room number 1, Second Floor, Admin Block
1st Main Road, Cambridge Layout,
Ulsoor
Bangalore
KARNATAKA |
08040917253
mukta.sachdev@msclinical.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACE Independant Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Subjects with mild and moderate melasma. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dermapen 4™ microneedling
device in conjunction with
MG-BL serum. |
Treatment using Dermapen 4™
microneedling device in
conjunction with MG-BL serum
will be provided at baseline,
week 2, 4 weeks and 6 weeks
to evaluate reduction in
melasma severity. Follow up
visits will be conducted at week
8 and week 12. The entire
duration of the study will be
approximately 13 weeks. |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1. Fitzpatrick skin phototype III to VI.
2. Subjects presenting with moderate facial Melasma.
3. Subjects who have not used any depigmenting agents or undergone any melasma treatment in the past 4-6 weeks as per dermatologists’ discretion.
|
|
| ExclusionCriteria |
| Details |
1. Subjects with other known skin condition that may impact the assessment.
2. Subjects with any active infectious condition (eg. Herpes labialis).
3. Subjects known to have bleeding and clotting disorders (self-dec
4. Subjects known to have connective tissue disorders. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in mMASI score in comparison to baseline |
baseline, weeks 2, 4, 6, 8 and 12 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of adverse events (AE), adverse device effects (ADE), serious adverse events (SAE), and serious adverse device effects (SADE), and device deficiency (DD) throughout the clinical investigation. |
baseline, weeks 2, 4, 6, 8 and 12 |
|
|
Target Sample Size
|
Total Sample Size="55"
Sample Size from India="55"
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)
|
13/04/2025 |
| 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="3"
Days="7" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Melasma is a very
common pigmentation disorder which significantly alters quality of life as per
its high visibility on the face. This study has been designed to evaluate the
effectiveness of Dermapen 4™ microneedling
device with MG-BL serum for
melasma treatment. Dermatological evaluations for mMASI, IGA, self assessment questionnaire will be performed at baseline, weeks 2, 4, 6, 8 and 12. |