| CTRI Number |
CTRI/2025/08/093398 [Registered on: 21/08/2025] Trial Registered Prospectively |
| Last Modified On: |
28/11/2025 |
| 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 see if the Dermapen 4™ microneedling device with MG-HA35+ serum helps improve atopic dermatitis. |
|
Scientific Title of Study
|
A study to evaluate the efficacy of Dermapen 4™ microneedling device in conjunction with MG-HA35+ serum in subjects with mild to moderate Active Atopic Dermatitis treatment over 12 weeks. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SKIN/EMAD/2025-04 version 1.0 dated 29 Apr 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 Operations |
| 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, Room no 2,
1st Main Road, Cambridge Layout
Ulsoor
Bangalore
KARNATAKA
560008
India |
| Phone |
08025361253 |
| 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 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 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= 3 |
| Name of Committee |
Approval Status |
| ACE INDEPENDENT ETHICS COMMITTEE |
Approved |
| ACE INDEPENDENT ETHICS COMMITTEE |
Approved |
| ACE Independant Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
subjects with mild to moderate atopic dermatitis |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dermapen 4™ microneedling device in conjunction with MG-HA35+ serum. |
Treatment usingDermapen 4™ microneedling device with MG-HA35+ serum will be done on baseline, week 2, week 4 and week 6. |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
1. Subjects in the age group of 18-55 years (both ages inclusive).
2. Subjects with mild to moderate active atopic dermatitis by Physician Global Assessment of score with (PGA score of 2 to 3)
|
|
| ExclusionCriteria |
| Details |
1. Subjects with any other skin condition that may impact the assessment.
2. Subjects known to have bleeding and clotting disorders.
3. Subjects who cannot manage AD without medication.
4. Subjects undergoing any other kind of treatment for active Atopic Dermatitis.
5. Subjects known to have connective tissue disorders.
6. Subjects currently taking any medication, which the investigator believes may influence the interpretation of the data.
7. A known history or present condition of allergic response to any cosmetic products.
8. Subjects on oral medications (e.g. steroids, anti-oxidant) which will compromise the study.
9. Has used any immunosuppressant drugs, steroids or immunotherapy within the past 30 days. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in the PGA score at all timepoints by measuring changes in AD parameters when compared to baseline |
Baseline, week 2, week 4, week 6 and week 12. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To evaluate the efficacy of Dermapen 4™ microneedling device in conjunction with the MG-HA35+ serum in the reduction of atopic dermatitis by measure the change in (IGAI) score at all time points in comparison to the baseline.
2. To evaluate the efficacy of Dermapen 4™ microneedling device in conjunction with the MG-HA35+ serum in the reduction of atopic dermatitis by measure change in the intensity of AD score at all time points in comparison to the baseline.
3. To evaluate the efficacy of the treatment in the reduction of atopic dermatitis as per the self-assessment questionnaire throughout the treatment period with Dermapen 4™ in conjunction with MG-HA35+ serum, when compared to baseline assessment.
4. Subject satisfaction at week 12 follow up with Dermapen 4 in conjunction with MG-HA35+ serum treatments in the reduction of atopic dermatitis. |
Baseline, week 2, week 4, week 6 and week 12. |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
05/09/2025 |
| 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)
|
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
|
Atopic dermatitis (AD), also known as eczema, is a chronic inflammatory skin condition characterized by pruritic and eczematous lesions. This study is designed to evaluate the effectiveness of Dermapen 4™ microneedling device with MG-HA35+ serum in the treatment of mild to moderate active atopic dermatitis.
Subjects will undergo treatment using Dermapen 4™ microneedling device with MG-HA35+ serum on the baseline visit, weeks 2, 4, 6 and followed up on week 12. Dermatological evaluations for AD severity and IGAI will be done at all defined time points. |