To Assess the Mildness of a Cosmetic Cleanser in Healthy Participants Using the Forearm-Controlled Application Technique (FCAT)

NCT ID: NCT03119688

Last Updated: 2019-05-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-08
• Study Completion Date: 2017-05-26

Brief Summary

The objective of this clinical study is to assess the relative mildness of a cosmetic facial cleanser in comparison to water through repeated application to the volar forearm using the FCAT wash procedure.

Detailed Description

This is a test site randomized, examiner blinded, positive and negative-controlled, single-center; Forearm Controlled Application Technique clinical study in healthy participants to assess the mildness potential of a cosmetic facial cleansing product.

Conditions

Skin Care

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Test product

0.09 milliliters (ml) of the cleanser (test product) will be applied on the allocated site on forearm topically.

Group Type: OTHER

Test Product

Intervention Type: OTHER

Micellar cleanser (0.09 ml)

Positive Control

Soap bar (positive control) will be applied on the allocated site on forearm by topical dermal administration of towel moistened with sterile water that had been rubbed onto the 100 g bar of soap for 6 seconds to generate a lather.

Group Type: OTHER

Positive Control

Intervention Type: OTHER

Bar Soap (rubbed for 6 seconds to generate a lather)

Negative Control

0.09 ml of sterile water (Reference Product) will be applied on the allocated site on forearm topically.

Group Type: OTHER

Reference Product

Intervention Type: OTHER

Sterile Water (0.09 ml)

No Treatment

An area of the forearm that remained unwashed and was included in the study as a reference for the treated areas.

Group Type: OTHER

No Treatment

Intervention Type: OTHER

Unwashed area of the forearm

Interventions

Test Product

Micellar cleanser (0.09 ml)

Intervention Type: OTHER

Positive Control

Bar Soap (rubbed for 6 seconds to generate a lather)

Intervention Type: OTHER

Reference Product

Sterile Water (0.09 ml)

Intervention Type: OTHER

No Treatment

Unwashed area of the forearm

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
• Aged between 18 and 65 years inclusive.
• Good general and mental health with, in the opinion of the investigator or medically qualified designee no clinically significant and relevant abnormalities in medical history or upon physical examination.
• Intact skin at the proposed application site; volar forearm.
• Clinical assessment for eligibility by a dermatologist to ensure participant is free of clinically relevant dermatological conditions.
• Fitzpatrick phototype I to IV.
• Trained examiner scores of zero for dryness and redness for each volar forearm at Screening visit (Visit 1) and each allocated test site on each forearm at Baseline visit.
• Agreement to comply with the procedures and requirements of the study and to attend the scheduled assessment visits.

Exclusion Criteria

• Women who are known to be pregnant or who are intending to become pregnant over the duration of the study.
• Women who are breast-feeding
• Any history of significant dermatological diseases or conditions or medical conditions known to alter skin appearance or physiologic response (e.g. diabetes,) which could, in the opinion of the Investigator, preclude topical application of the investigational products and/or interfere with the evaluation of the test site reaction.
• Presence of open sores, pimples, or cysts at the application site.
• Active dermatosis (local or disseminated) that might interfere with the results of the study.
• Considered immune compromised.
• History of diseases aggravated or triggered by ultraviolet radiation.
• History of atopic dermatitis.
• Participants with dermatographism.
• Currently using any medication which in the opinion of the investigator, may affect the evaluation of the study product, or place the participant at undue risk.
• Use of the following topical or systemic medications: immunosuppressants, antihistamines, non-hormonal anti-inflammatory drugs, and corticosteroids upto 2 weeks before screening visit.
• Oral or topical treatment with vitamin A acid and/or its derivatives up to 1 month before the screening visit.
• Intention of being vaccinated during the study period or has been vaccinated within 3 weeks of the screening visit.
• Currently receiving allergy injections, or received an allergy injection within 7 days prior to Visit 1, or expects to begin injections during study participation.
• Previous history of atopy, allergic reactions, irritation or intense discomfort feelings to topical-use products, cosmetics or medication.
• Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
• Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit.
• Previous participation in this study.
• Recent history (within the last 5 years) of alcohol or other substance abuse.
• Intense sunlight exposure or sun tanning sessions, including use of self-tanning products on the test areas up to 14 days before the Screening evaluation.
• Intention of bathing (in the sea or pool), sauna, water sports, or activities that lead to intense sweating.
• Any Participant who, in the judgment of the Investigator and Dermatologist, should not participate in the study.
• Any skin marks on the test site that might interfere with the evaluation of possible skin reactions (e.g. pigmentation disorders, vascular malformations, scars, tattoos, excessive hair, numerous freckles).
• Prisoner or involuntary incarcerated participant
• Participant from an indigenous tribe.
• An employee of the sponsor or the study site or members of their immediate family.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)

Locations

GSK Investigational Site

Campinas, São Paulo, Brazil

GSK Investigational Site

Campinas, São Paulo, Brazil

Countries

Brazil

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

207619

Identifier Type: -

Identifier Source: org_study_id