To evaluate the photo-protector effect of BC\_3 (E212657) formulated in SPF30 compared to SPF30 alone on real sun exposure induced pigmentation in healthy volunteers
The study intends to evaluate the clinical efficacy of the photo-protective cosmetic products (758637 10 and 758637 15) and to compare the photo-protection potential of the two products, after its application for 7 days on healthy female volunteers under the normal conditions of use planned by the sponsor. The study will also evaluate the tolerance of the two products on the skin of healthy female volunteers. The photo-protection is generally concerned with the reduction of exposure to ultra violet radiations, specifically UV-B and UV-A, primarily from the sun. The harmful radiations from the sun can cause various skin issues which can be as minor as skin tanning and as major as skin cancer. The photo-protective products can help in protection of the skin from the harmful sun radiation either by blocking them or absorbing them and preventing the rays to damage the skin The formula number of both the products are 758637 10 and 758637 15. The SPF value of both the product is 30.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
50
long-UVA absorber
placebo
CIDP Biotech India Pvt. Lt
New Delhi, India
RECRUITINGTo compare the photo-protective efficacy of two cosmetic investigational products by Clinical scoring done by the study investigator
color chart
Time frame: Change from baseline at Day 7
To compare the photo-protective efficacy of two cosmetic investigational products by Non invasive bio-instrumental skin color assessments
Chromameter
Time frame: Change from baseline at Day 7
To compare the photo-protective efficacy of two cosmetic investigational products by Self assessment
questionnaire
Time frame: Change from baseline at Day 7
To evaluate the tolerance of both the photo protective cosmetic products (A - 758637 10 and B - 758637 15)
The local intolerances reported by the subjects and observed by the investigator
Time frame: Change from baseline at Day 7
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