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Testing the Effect of a Skincare Product on Melasma in Healthy Individuals

The objective of this study will be to evaluate the in vivo safety and efficacy of skin care formulation in terms of reduction in melasma on healthy human subjects - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/12/078257
Enrollment
36
Registered
2024-12-17
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

None listed

Interventions

Intervention1: Cysteamine, Alpha Arbutin, Niacinamide, Tamarindus Indica Cream: The Product is applied on melasma patches on face once in night for the period of 112 days. Control Intervention1: Nil:

Sponsors

Glenmark Pharmaceuticals Ltd.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Indian Male and Female subjects 2. Healthy subjects 3. Skin is healthy on the studied anatomic unit 4. Human subjects with melasma

Exclusion criteria

Exclusion criteria: 1. Being pregnant or breastfeeding or having stopped to breastfeed in the past three months. 2. Having refused to give her assent by not signing the consent form. 3. Taking part in another study liable to interfere with this study. 4. Being insulin-dependent diabetic or non-insulin-dependent diabetic with a recent therapy (less than 6 months) 5. Having progressive asthma. 6. Being epileptic. 7. Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months) 8. Having cutaneous hypersensitivity 9. Having a diagnosed or highly probable allergy to one or several compounds of cosmetic products. 10. Following a chronic medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol) 11. Having consumed caffeine-based products (coffee, cola, tea …), alcohol, highly spiced foods and/or smoked in the two hours preceding the measurements. 12. Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months. 13. Having changed her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit 14. Having applied a cosmetic product (included make-up) or skin care product on the studied areas the day of the study (only face cleaned with water is accepted)

Design outcomes

Primary

MeasureTime frame
Reduction in melasmaTimepoint: Baseline, 28 days, 56 Days, 84 Days, 112 Days

Secondary

MeasureTime frame
Change in pigmentation, change in MELASQOL (quality of lifestyle) related to melasma, Cosmetic AcceptabilityTimepoint: Baseline, 28 days, 56 Days, 84 Days, 112 Days

Countries

India

Contacts

Public ContactDr Mohit Lalvani

MASCOT-SPINCONTROL India Pvt. Ltd.

poojayadav@mascotspincontrol.in02243349191

Outcome results

None listed

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