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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- evaluate of efficacy and safety of a skin care formulation in terms of even skin tone, reduction in pigmentation (dark spot), radiant skin
Study Overview
Brief Summary
Objective:
PRIMARY OBJECTIVE To evaluate the in-vivo efficacy andsafety of a skin care formulation in terms of even skin tone, reduction inpigmentation (dark spot) & radiant skin on healthy male & femalesubjects.
SECONDARY OBJECTIVE To evaluate the in-vivo efficacy of askin care formulation in terms signs of ageing: minimize fine lines, smoothskin texture, reducing dark circles and improvement in hydration on healthymale & female subjects
Duration of study: 28 days study
Kinetics: T0, T+14 days and T+28 days
Population: 36 (18 Females & 18 Males) volunteers
The evaluation is performed using:
-
Subject’s Self Evaluation,
-
Dermatological Evaluation: Cosmetic Acceptability,
-
Dermatological Evaluation: Efficacy
-
Chromametry
-
Corneometry
-
CLBT (Color, Luminosity, Brightness, Transparency)
Study Design
- Study Type
- Interventional
- Allocation
- Not Applicable
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 52.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Having dull skin and uneven skin tone Having pigmentary spot on the face of grade 2 to grade 6 according to the Bazins atlas Having Crows feet wrinkle of grade 2 and above according to the Bazins atlas Having visible under eye dark circle.
Exclusion Criteria
- •Having started, changed or interrupted one hormonal treatment during the past 3 months Having started, changed or stopped her tobacco consumption in the previous 6 months Having consumed caffeine-based products, alcohol, highly spiced food and/or not smoke in the two hours preceding the measurements Having taken a medicinal treatment which could lead to hyper pigmentation in the previous 6 months Taking oral supplements with major or minor effect on whitening of skin 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 Having applied products with anti-wrinkle action in the 2 weeks preceding the start of the study Having applied products with a depigmenting/ whitening action in the 4 weeks preceding the start of the study Having undergone physical and/or chemical treatments of the spots in the previous 6 months 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.
Outcomes
Primary Outcomes
evaluate of efficacy and safety of a skin care formulation in terms of even skin tone, reduction in pigmentation (dark spot), radiant skin
Time Frame: T0, T14 days and T28 days
Secondary Outcomes
- efficacy of a skin care formulation in terms signs of ageing: minimize fine(lines, smooth skin texture, reducing dark circles and improvement in hydration)