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A Study to check the effectiveness and Safety of the Serum with Microneedling Compared to Microneedling Alone for Reducing Hyperpigmentation.

Evaluation of the efficacy and tolerability of MelaB3 serum as an adjunct to microneedling, versus microneedling alone in the treatment of Melasma and PIHP in Indian adult population - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/08/093382
Enrollment
80
Registered
2025-08-21
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

None listed

Interventions

Intervention1: MelaB3 serum + microneedling procedure: Trial participants will apply the product at home twice daily (morning and evening) during the study and undergo three microneedling sessions at

Sponsors

La Roche-Posay Laboratoire Dermatologique
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male and female participants aged above 18 to 65 years 2. Fitzpatrick skin phototypes III to V 3. Trial participants must present with only one facial pigmentary condition either melasma or PIHP 4. Trial participants in good general and mental health in the opinion of the investigator 5. Trial participants demonstrating understanding of the study procedures restrictions and willingness to participate as evidenced by voluntary written informed consent and having received a signed and dated copy of the consent form

Exclusion criteria

Exclusion criteria: 1.Female trial participants who are pregnant or nursing woman or woman planning to get pregnant during the study (self-perceived) 2.Female trial participant who gave birth less than 3 months prior to Day -14, who is pregnant, breast-feeding or who plans to become pregnant during the study; 3.Male trial participant with beard or facial hair, which would interfere with clinical evaluation or clinical procedure baseline); 4.Trial participant with known allergy to any ingredients of the test products (tested product and sunscreen); 5.Trial participant with any inflammatory dermatosis of the face such as seborrheic dermatitis, rosacea etc.

Design outcomes

Primary

MeasureTime frame
Evaluate & Compare the efficacy levels between treatment groups by Change from Baseline in participants with melasma & PIH by dermatological and instrumental assessmentsTimepoint: D1,D28, D56, D84

Secondary

MeasureTime frame
Evaluate & Compare the efficacy & safety of the serum by participant self-assessment questionnaire and by dermatological evaluation.Timepoint: D1,D28, D56, D84

Countries

India

Contacts

Public ContactSudhanthiran S

MS Clinical Research Pvt. Ltd

ritambhara@msclinical.com08040917253

Outcome results

None listed

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