A clinical study to evaluate the effectiveness of the test product on the tanned skin along with its safety on healthy adult female subjects.
Overview
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- To assess the efficacy of test product on tanned skin, based on clinical, instrumental and subjective evaluations
Overview
Brief Summary
This is an open label, non-randomized, single-center, single-arm clinical study to evaluate the effectiveness of the test product on the tanned skin along with its safety on healthy adult female subjects.
The potential subjects will be screened as per the inclusion and exclusion criteria only after obtaining written informed consent from the subjects.
All eligible subjects will undergo clinical evaluation by a Dermatologist, instrument evaluation and subjective evaluation. Safety will be assessed throughout the study by monitoring adverse events.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 45.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Subjects with fitzpatrick skin type IV and V.
- •Subjects with visible skin tan on face, at least 2 shade darker than a Sun protected upper volar arm.
- •Subjects with at least 2 dark spots / blemishes.
- •Subjects willing to provide written informed consent to participate in the study.
Exclusion Criteria
- •Subjects with dark facial skin as determined by dermatologist.
- •Subjects who are receiving topical or systemic treatments for pigmentation within the last 30 days.
- •Subjects using other marketed skin lightening products during the study period or in the past 6 weeks.
- •Subjects using any other night cream during the study period.
Outcomes
Primary Outcomes
To assess the efficacy of test product on tanned skin, based on clinical, instrumental and subjective evaluations
Time Frame: Day 01, Day 03, Day 07, Day 14 and Day 28.
Secondary Outcomes
No secondary outcomes reported
Investigators
Dr Bhagirath Patel
Cliantha Research