Photoprotection Efficacy With Sunscreen Formulas Containing the Cyclic Merocyanine Long-UVA Absorber MCE, Under Real Sun Exposure

NCT04865055 | Unknown

• 1 other identifier: 14CSI044
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Real Life Pigmentation

Outcome Measures

Primary Outcomes (3)

• To compare the photo-protective efficacy of two cosmetic investigational products by Clinical scoring done by the study investigator

  color chart

  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

  Change from baseline at Day 7

• To compare the photo-protective efficacy of two cosmetic investigational products by Self assessment

  questionnaire

  Change from baseline at Day 7

Secondary Outcomes (1)

• To evaluate the tolerance of both the photo protective cosmetic products (A - 758637 10 and B - 758637 15)

  Change from baseline at Day 7

Study Arms (2)

cyclic merocyanine

ACTIVE COMPARATOR

cyclic merocyanine long-UVA absorber

Other: cyclic merocyanine

placebo

PLACEBO COMPARATOR

Other: placebo

Interventions

cyclic merocyanine OTHER

long-UVA absorber

cyclic merocyanine

placebo OTHER

placebo

placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• The subject is a healthy female volunteer aged between 18-45 years old
• Subjects with skin phototype IV-V and ITA° 4° to 20°.
• Subject who has given freely his or her informed consent and who is cooperative and aware of the necessity and duration of the controls so that perfect adherence to the protocol can be expected
• Subject who is able to read and understand documents transmitted (information sheet and consent form)
• If the subject is a female of childbearing potential and is willing to use a reliable mean of contraception\*(for at least one month before the beginning of the study, and throughout the study) or menopausal women (absence of menstrual periods for one year or more)
• Accepting to stop the usage of all facial skin cosmetics (lotion, cream, powder, make-up) throughout the study duration.
• Subject willing to expose / her face and arms to sun for around 1- 2 hours morning and 1-2 hours afternoon during the day
• sexually active females of childbearing potential should either be surgically sterile (oophorectomy, hysterectomy ortubal ligation), or should use a medically accepted contraceptive regimen: systemic contraceptive (oral, implant,injection), diaphragm or cervical cap, Intravaginal device, intrauterine device (IUD), condoms.

You may not qualify if:

• Female subject who is pregnant (as demonstrated by positive UPT on screening visit) or planning to get pregnant during the study.
• Female subjects who are breast-feeding.
• Subject with a known history or present condition of allergic response to any cosmetic products.
• Subject with photosensitive dermatosis (sensitive to sun exposure).
• Subject having skin diseases (e.g. moderate to severe acne vulgaris or nodulocystic acne, psoriasis,naevi, freckles, excess hair, uneven skin tones, vitiligo, active atopic dermatitis, pigmented contact dermatitis or other cutaneous manifestations),on face and upper portion of arms which can interfere with the test readings.
• Any treatment, topical or systemic, taken in the weeks preceding the screening, which is likely to interfere with the evaluation of the efficacy of the product(s) being studied.
• Subject undergoing anti-inflammatory, corticoids or retinoids therapy by oral or topical way
• Subject having used de-pigmenting products, masks exfoliant product on the investigational areas in last 4 weeks.
• Subject who has been deemed by the investigator as potentially unable or unwilling to comply with the protocol
• Subject enrolled in another clinical trial during the study period
• Personnel of the investigational site.
• Subject with any scar or tatoo on the investigational areas specifically on the face and upper arms

Sponsors & Collaborators

• L'Oreal: lead

Study Sites (1)

CIDP Biotech India Pvt. Lt

New Delhi, 110016, India

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: April 29, 2021
• Study Start: April 29, 2021
• Primary Completion: April 29, 2021
• Study Completion: April 29, 2021
• Last Updated: April 29, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: DECEMBER 2021

Locations

IN (1)