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Safety and efficacy assessment of Product on skin

PRIMARY OBJECTIVE To evaluate the in-vivo efficacy and safety of a skin care formulation in terms of even skin tone, reduction in pigmentation (dark spot)& radiant skin on healthy male & female subjects. SECONDARY OBJECTIVE To evaluate the in-vivo efficacy of a skin care formulation in terms signs of ageing: minimize fine lines, smooth skin texture, reducing dark circles and improvement in hydration on healthy male & female subjects

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/03/040715
Enrollment
36
Registered
2022-03-02
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-01

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

Conditions

None listed

Interventions

Intervention1: KMBF Face oil (KMBF â?? VR 01) : Product A: Approximately 4-5 drops of the Product will be applied once in a day on whole face. for period of 28 days. Control Intervention1: NIL: NIL

Sponsors

Kama Ayurveda Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Having dull skin and uneven skin tone 2. Having pigmentary spot on the face of grade 2 to grade 6 according to the Bazins atlas 3. Having Crows feet wrinkle of grade 2 and above according to the Bazins atlas 4. Having visible under eye dark circle 5. Presenting Fitzpatrick skin type III to V with chromameter i.e. ITA° value between -30° & 41° on cheek bones.

Exclusion criteria

Exclusion criteria: 1. Having started, changed or interrupted one hormonal treatment during the past 3 months 2. Having started, changed or stopped her tobacco consumption in the previous 6 months 3. Having consumed caffeine-based products, alcohol, highly spiced food and/or not smoke in the two hours preceding the measurements 4. Having taken a medicinal treatment which could lead to hyper pigmentation in the previous 6 months 5. Taking oral supplements with major or minor effect on whitening of skin 6. Having had beauty treatment e.g. skin cleansing, exfoliation, scrub, mask or having applied self tanning products in the week preceding the start of the study 7. Having applied products with anti-wrinkle action in the 2 weeks preceding the start of the study 8. Having applied products with a depigmenting/ whitening action in the 4 weeks preceding the start of the study 9. Having undergone physical and/or chemical treatments of the spots in the previous 6 months 10. Having a suntanned skin on the studied areas which could interfere with the evaluations of the study For males, having not shaved their beard 24 hours prior to the day of measurement

Design outcomes

Primary

MeasureTime frame
Even skin tone, reduction in pigmentation (dark spot), radiant skin and skin brightness, safety of a skinTimepoint: Baseline, 14 days and 28 days—

Secondary

MeasureTime frame
Minimize fine lines, smooth skin texture, reducing dark circles and improvement in skin hydrationTimepoint: baseline, 14 days and 28 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