A study to see if the Dermapen 4 microneedling device with MG-HA35+ serum helps improve atopic dermatitis.

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. - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/08/093398

Enrollment

Registered

2025-08-21

Start date

Unknown

Completion date

Unknown

Last updated

2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: 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 w

Eligibility

Inclusion criteria

Inclusion criteria: 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)

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Change in the PGA score at all timepoints by measuring changes in AD parameters when compared to baselineTimepoint: Baseline, week 2, week 4, week 6 and week 12.	—

Secondary

Measure	Time frame
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.Timepoint: Baseline, week 2, week 4, week 6 and week 12.	—

Measure

Time frame

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.Timepoint: Baseline, week 2, week 4, week 6 and week 12.

—

Countries

India

Contacts

Public ContactSudhanthiran S

MS Clinical Research Pvt. Ltd.

ritambhara@msclinical.com08040917253

Outcome results