Clinical trial NCT03119688: To Assess the Mildness of a Cosmetic Cleanser in Healthy Participants Using the Forearm-Controlled Application Technique (FCAT)
Official title: A Clinical Study to Assess the Mildness of a Cosmetic Cleanser in Healthy Subjects Using the Forearm-Controlled Application Technique (FCAT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Care
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2017-04-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: Change From Baseline in Visual Assessment of Dryness at Day 5
timeFrame: At Baseline and Day 5 (3 hours post last wash procedure)
Secondary outcomes:
measure: Change From Baseline in Visual Assessment of Redness at Day 5
timeFrame: At Baseline and Day 5 (3 hours post last wash procedure)
measure: Change From Baseline in Visual Assessment of Dryness at Day 2, 3, and 4
timeFrame: At Baseline and Day 2, 3, and 4 (3 hours post last wash procedure)
measure: Change From Baseline in Visual Assessment of Redness at Day 2, 3, and 4
timeFrame: At Baseline and Day 2, 3, and 4 (3 hours post last wash procedure)
measure: Change From Baseline in Transepidermal Water Loss (TEWL) at Day 5
timeFrame: At Baseline and Day 5 (3 hours post last wash procedure)
measure: Change From Baseline in Skin Moisturisation at Day 5
timeFrame: At Baseline and Day 5 (3 hours post last wash procedure)
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: GSK Investigational Site
state: São Paulo
city: Campinas
country: Brazil
facility: GSK Investigational Site
state: São Paulo
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
affiliation: GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: