A multicenter study to evaluate microneedling with a skin serum for treating rosacea over 20 weeks.

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. - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/12/098395

Enrollment

Registered

2025-12-03

Start date

Unknown

Completion date

Unknown

Last updated

2026-02-02

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-EXO-SKIN serum: Treatment using Dermapen 4 microneedling device with MG-EXO-SKIN serum will be done on baseline, week 4, week 8,

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Change in rosacea severity using IGA scores at all defined time points when compared to baseline.Timepoint: Baseline, Week 4, Week 8, Week 12, Week 16 and Week 20	—

Secondary

Measure	Time frame
Change in IGAI scores and for rosacea from visit 3 onwards when compared to baselineTimepoint: 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.Timepoint: 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.Timepoint: 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.Timepoint: Week 20	—

Measure

Time frame

Change in IGAI scores and for rosacea from visit 3 onwards when compared to baselineTimepoint: 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.Timepoint: 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.Timepoint: 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.Timepoint: Week 20

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Countries

India

Contacts

Public ContactSudhanthiran S

MS Clinical Research Pvt. Ltd

ritambhara@msclinical.com08040917253

Outcome results