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A 16-weeks study to check whether Dermapen 4 microneedling device with MG-R.A.S serum reduces stretch marks.

A study to evaluate the efficacy of Dermapen 4 microneedling device in conjunction with MG-R.A.S serum for reduction in the appearance of stretch marks over 16 weeks. - NIL

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/02/081472
Enrollment
55
Registered
2025-02-28
Start date
Unknown
Completion date
Unknown
Last updated
2025-03-03

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 with MG-R.A.S serum: Treatment using Dermapen 4 microneedling device with MG-R.A.S serum will be provided at baseline, week 4, week 8 and week 12. Cont

Sponsors

Equipmed USA LLC
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Female subjects aged between 19-50 years (both ages inclusive). 2. Subjects having striae on their abdomen for more than 4 months. 3. Fitzpatrick skin phototypes III to VI.

Exclusion criteria

Exclusion criteria: 1. Subjects known to have hypertrophic scarring, keloids and connective tissue disorders (self-declared). 2. Subjects known to have bleeding and clotting disorders (self-declared). 3. Subjects currently taking any medication which the investigator believes may influence the interpretation of the data. 4. Subjects having clinically significant systemic or cutaneous disease, chronic illness or have undergone major surgery in the last year. 5. Subjects having any health condition and /or pre-existing or dormant dermatologic disease on the body (e.g. Psoriasis, rosacea, seborrheic dermatitis, vitiligo, hyper or hypo skin pigmentation conditions) that the investigator or designee deems inappropriate for participation or could interfere with the outcome of the clinical investigation. 6. Subjects using any other systemic, topical or light- based treatments for stretch marks during clinical investigation period.

Design outcomes

Primary

MeasureTime frame
Change in stretch mark severity score in comparison to baseline at all defined time points.Timepoint: baseline, Week 4, week 8, week 12, week 16

Secondary

MeasureTime frame
Change in skin hydration and IGAI scores. Subject self-assessment and satisfaction questionnaires.Timepoint: Baseline, week 4, week 8, week 12 and week 16.

Countries

India

Contacts

Public ContactSudhanthiran S

MS Clinical Research Pvt. Ltd.

ritambhara@msclinical.com08025361253

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026