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Evaluation of safety & Efficacy of cosmetic product

TO EVALUATE AND COMPARE THE SAFETY AND EFFICACY OF CYSTEAMINE 5% & KOJIC ACID 2% IN MELASMA. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/10/058850
Enrollment
72
Registered
2023-10-19
Start date
Unknown
Completion date
Unknown
Last updated
2023-11-13

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 5%: Sufficient quantity of Product will be used to wash the whole face, once in a day at night for the period of 112 days Intervention2: Kojic acid 2%: Sufficient quantity of

Sponsors

GLENMARK PHARMACEUTICALS LTD.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Indian Female subjects 2. Healthy subjects 3. Age 18 years and above (up to 60 years). 4. Skin is healthy on the studied anatomic unit 5. 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
Melasma reductionTimepoint: Day 0, Day 14, Day 28, Day 56 and Day 112

Secondary

MeasureTime frame
Change in quality of lifestyle related to melasma and number of Events, cosmetic acceptibility, reduction in melanin content of pigmentary spotsTimepoint: Day 0, Day 14, Day 28, Day 56 and Day 112

Countries

India

Contacts

Public ContactDr Mohit Lalvani

MASCOT-SPINCONTROL India Pvt. Ltd.

raji@mascotspincontrol.in02243349191

Outcome results

None listed

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