Skip to content

Safety and efficacy assessment of Product

to evaluate in-vivo safety and efficacy of skin care formulation on healthy female subjects

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/05/042920
Enrollment
12
Registered
2022-05-30
Start date
Unknown
Completion date
Unknown
Last updated
2022-06-27

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

Conditions

None listed

Interventions

Intervention1: Skin Brightening Cream: 1 gm of Product will be applied once in a day on whole face for period of 56 days Control Intervention1: NIL: NIL

Sponsors

MERCK PERFORMANCE MATERIALS PVT LTD
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1 Indian or Asian female subjects 2 Healthy subjects (no infectious and evolutive pathology which could make the subject vulnerable and stop the study, no pathology which could interfere with the study, no symptom in the process of an exploratory checkup. 3 Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar) Specific criteria 4 Subjects having visible melasma, having crows feet wrinkles of grade 2 and above.

Exclusion criteria

Exclusion criteria: 1 Being pregnant or breastfeeding or having stopped to breastfeed in the past three months. 2 Having refused to give his/her assent by not signing the consent form and Informed consent form 3 Taking part in another study liable to interfere with this study 4 Being known diabetic case 5 Known asthma 6 Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area (except for specific studies on a determined dermatosis) 7 Being known thyroid case 8 Being epileptic. 9 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 or corticosteroid by any route (the only medication permitted is paracetamol) 10 Known case of hypersensitivity. 11 Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products. 12 Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months. 13 Having changed their cosmetic habits except those required by the protocol in the 14 days preceding the start of the study on the studied anatomic unit. 14 Having applied a cosmetic product (included make-up) on the studied areas 48 hours prior study Having started, changed or stopped a hormonal treatment (hormonal contraception, Hormone Replacement Therapy, thyroidâ?¦) in the past 3 months. 16 Having taken an oral retinoid-based treatment in the past 6 months 17 Having taken a local retinoid-based treatment on the studied areas in the previous month 18 Having had beauty treatment (e.g. scrub, manicure, self-tanning product â?¦) in the previous week 19 Having practiced water activities (swimming pool, sauna, hammam, baleneotherapy etc.) in the previous week. 20 Having consumed caffeine-based products (coffee, cola, tea, â?¦), alcohol, highly spiced food and/or not smoke in the two hours preceding the measurements 21 Having practiced intensive sports during the day prior to the T0 measurements 22 Having wounds, Scars, sunburns, tattoos and piercing on test site. 23 Having hair on test site. 24 Having applied another product than water on the studied areas in the morning of the T0 measurements 25 Having had an intensive UV exposition on the inner forearm (solariums, sun) prior to T0 measurements. 26 Having used cosmetic product on the studied area during 24 hours prior to T0 measurements.

Design outcomes

Primary

MeasureTime frame
Reduction of melasma, Products safety on skinTimepoint: 28 days, 56 days

Secondary

MeasureTime frame
Improvement in skin moisturization, skin firmness and skin brightening & reduction in density of wrinkles and fine linesTimepoint: 28 days, 56 days

Countries

India

Contacts

Public ContactMr Mohit Lalvani

MASCOT-SPINCONTROL India Pvt. Ltd.

raji@mascotspincontrol.in02243349191

Outcome results

None listed

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