Photoprotection Efficacy With Sunscreen Formulas Containing the Cyclic Merocyanine Long-UVA Absorber MCE Under UV Day Light Exposure

NCT04866797 | Unknown

• 1 other identifier: ACR_UVDL2_1381
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the photo-protector effect of BC\_3 (E212657) formulated in SPF compared to SPF alone on UV Day Light induced pigmentation in healthy volunteers

Conditions

Pigmentation; Redness

Keywords

sunscreen; ultraviolet

Outcome Measures

Primary Outcomes (2)

• Biophysical non-invasive assessment of skin color by using Chromameter

  Delta E, ITA, Delta a

  Change from baseline at Day 7

• Clinical investigator's assessment by clinical score

  Visual scoring of pigmentation from 0 to 9

  Change from baseline at Day 7

Secondary Outcomes (1)

• Safety was assessed by recording Adverse Events, including cutaneous reactions (local intolerance)

  Change from baseline at Day 7

Study Arms (2)

cyclic merocyanine long-UVA absorber

ACTIVE COMPARATOR

Other: cyclic merocyanine

placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

cyclic merocyanine OTHER

long-UVA absorber

cyclic merocyanine long-UVA absorber

Placebo OTHER

Placebo

placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy female or male volunteer;
• to 40 years old;
• uniform skin color all over on the investigational zones;
• skin type III or IV according to the Fitzpatrick classification;
• female of childbearing potential who are sexually actives using a reliable mean of contraception (for at least three month before the beginning of the study, and throughout the study);
• Female of childbearing potential willing to undergo urine pregnancy test
• informed about the study objectives and procedures, and able to understand them;
• Able to stay on the prone position more than 2 hours.
• willing and able to fulfill the study requirements and schedule.
• All subjects will have to give their written informed consent.

You may not qualify if:

• having planned U.V. exposure of the investigational zones (sunlight or sunbeds) throughout the study;
• having sunburn (erythema) on the back;
• dermatological disorders affecting the investigational zones (presence of naevi, freckles, excess hair or uneven skin tones, vitiligo, photo-dermatological problems);
• history of skin cancer;
• history of abnormal response to sun;
• presence of recent suntan (according to Investigator opinion) or photo-test marks;
• history of allergy, hypersensitivity, or any serious reaction to any cosmetic product;
• any concomitant medical condition that may interfere with the study conduct in the opinion of the investigator;
• unable to be contacted by phone in case of emergency;
• Deprived of liberty by adjunction or by official decision.

Sponsors & Collaborators

• L'Oreal: lead

Study Sites (1)

CIDP Biotechnology

Bucharest, 011607, Romania

RECRUITING

MeSH Terms

Conditions

Erythema

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

AUDREY GUENICHE, pHD

CONTACT

+33660992467; agueniche@rd.loreal.com

ROMAIN DE DORMAEL, pHD

CONTACT

+33609556837; rdormael@rd.loreal.com

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 30, 2021
• Study Start: April 29, 2021
• Primary Completion: June 29, 2021
• Study Completion: June 29, 2021
• Last Updated: April 30, 2021

Record last verified: 2021-04

Data Sharing

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

Locations

RO (1)