| CTRI Number |
CTRI/2025/12/098395 [Registered on: 03/12/2025] Trial Registered Prospectively |
| Last Modified On: |
22/01/2026 |
| 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 multicenter study to evaluate microneedling with a skin serum for treating rosacea over 20 weeks. |
|
Scientific Title of Study
|
A multicentric, full face, baseline-controlled study to evaluate the efficacy of Dermapen 4™ microneedling device in conjunction with MG-EXO-SKIN serum for rosacea treatment over 20 weeks. |
| Trial Acronym |
NIL |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| SKIN/EMRS/2025-05 Version 2.0 19 Dec 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 |
327/15, Ground Floor, Room no 1, 1st Main Road, Cambridge Layout Ulsoor
Bangalore
KARNATAKA
560008
India |
| Phone |
08040917253 |
| Fax |
|
| Email |
mukta.sachdev@msclinical.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ritambhara |
| Designation |
Director - Business and Operation |
| Affiliation |
MS Clinical Research Pvt. Ltd |
| Address |
327/15, Ground floor, room no 2, 1st Main Road Cambridge Layout, Ulsoor
Bangalore
KARNATAKA
560008
India |
| Phone |
08040917253 |
| 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 |
Department of Skin Sciences,
#324, Second Floor, 1st Main Road, Cambridge Layout, Ulsoor
Bangalore
KARNATAKA
560008
India |
| Phone |
08040917253 |
| Fax |
|
| Email |
sudhan@msclinical.com |
|
|
Source of Monetary or Material Support
|
| Equipmed USA LLC, 4695 Macarthur Crt, Newport Beach, CAL 92660, United States of America |
|
|
Primary Sponsor
|
| Name |
Equipmed USA LLC |
| Address |
4695 Macarthur Crt, Newport Beach, CAL 92660, United States of America |
| Type of Sponsor |
Other [Medical Devices] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anil Ganjoo |
Dr Ganjoos Skin and Cosmetology Centre |
105/4, LSC, Gujranwala Town Delhi - 110009
New Delhi
DELHI |
9811066584
drganjoo1965@gmail.com |
| Dr Rohit Batra |
Dr Rohit Batra’s DermaWorld Skin & Hair Clinic |
Q-4, Rajouri Garden, New Delhi – 110027
New Delhi
DELHI |
9911200050
drrohitbatra@gmail.com |
| Dr Mukta Sachdev |
MS Clinical Research Pvt Ltd |
Department of Skin Sciences, 324 1st Main Road, Second Floor, Cambridge Layout, Ulsoor
Bangalore
KARNATAKA |
08040917253
mukta.sachdev@msclinical.com |
| Dr Mukta Sachdev |
MS Clinical Research Pvt Ltd |
327/15, Room No 1, 2nd floor, 1st Main Road, Cambridge Layout, Ulsoor
Bangalore
KARNATAKA |
08040917253
mukta.sachdev@msclinical.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| ACE INDEPENDENT ETHICS COMMITTEE |
Approved |
| ACE Independent Ethics Committee |
Approved |
| GSER-IEC |
Approved |
| GSER-IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Participants with mild to moderate rosacea based on IGA scale for rosacea severity. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dermapen 4™ microneedling device in conjunction with MG-EXO-SKIN serum |
Treatment using Dermapen 4™ microneedling device with MG-EXO-SKIN serum will be done on baseline, week 4, week 8, week 12, and week 16. |
| Comparator Agent |
Nil |
Nil |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and Female trial participants aged between 18-50 years (both ages inclusive).
2. Trial participants having mild to moderate rosacea based on IGA scale for rosacea.
3. Trial participants having Fitzpatrick skin phototypes III to VI.
|
|
| ExclusionCriteria |
| Details |
1. Trial participants with rosacea fulminans/ conglobate.
2. Trial participants with any known skin condition that may impact the assessment.
3. Trial participants with active skin condition such as Herpes Labialis infection.
4. Trial participants known to have bleeding and clotting disorders.
5. Trial participants known to have connective tissue disorders.
6. Trial participants who are pregnant or nursing (self-declared).
7. Trial participants with skin allergy history or atopic dermatitis or psoriasis.
8. Trial participants who are on any kind of supplements or taking nutraceuticals.
9. Trial participant who is an employee of the sponsor or the CRO. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in rosacea severity using IGA scores at all defined time points when compared to baseline. |
Baseline, Week 4, Week 8, Week 12, Week 16 and Week 20 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in IGAI scores and for rosacea from visit 3 onwards when compared to baseline |
Baseline, Week 4, Week 8, Week 12, Week 16 and Week 20 |
| Change in Clinician Severity Assessment Grading Scale on Erythematotelangiectatic Rosacea at all defined time points in comparison to baseline. |
Baseline, Week 4, Week 8, Week 12, Week 16 and Week 20 |
| Trial participant self-assessment for change in rosacea status, at all time points when compared to baseline. |
Baseline, Week 4, Week 8, Week 12, Week 16 and Week 20 |
| Trial participant satisfaction at week 20 (visit 7), after treatment with Dermapen 4™ in conjunction with MG-EXO-SKIN for the treatment of rosacea. |
Week 20 |
|
|
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)
|
02/11/2026 |
| 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="5"
Days="7" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
Rosacea is a common chronic inflammatory skin disorder primarily affecting the face with a global prevalence of 5.5%. It is characterized by flushing, non-transient erythema, papules/pustules, telangiectasia, and phymatous changes. Secondary manifestations, such as itching, burning, or stinging, are also often observed in affected individuals. This study has been designed to evaluate the effectiveness of Dermapen 4™ microneedling device in conjunction with MG-EXO-SKIN serum in the treatment of rosacea. Participants will undergo treatment using Dermapen 4™ microneedling device with MG-EXO-SKIN serum on the baseline visit, weeks 4, 8, 12,16 and followed up on week 20. Dermatological assessments for rosacea severity using IGA scores and Clinician Severity Assessment Grading Scale on Erythematotelangiectatic Rosacea will be done at all defined time points. |