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

NCT03119688 | Completed Results

• 1 other identifier: 207619
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Skin Care

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Visual Assessment of Dryness at Day 5

  Skin dryness was assessed by a trained examiner according to following the scoring scale: 0 (No dryness); 1 (Patches of slight powederiness and occasional patches of small scales may be seen, distribution generalized.); 2 (Generalised slight powederiness, early cracking or occasional small lifting scales may be present); 3 (Generalised moderate powederiness and/or heavy cracking and lifting scales; 4 (Generalised heavy powederiness and/or heavy cracking and lifting scales); 5 (Generalised high cracking and lifting scales, eczematous change may be present, powederiness may be present but not prominent, may see bleeding crack); 6 (Generalised severe cracking, eczematous change may be present, bleeding cracks may be present, scale large may be beginning to disappear). Lower scores reflect less dry skin.

  At Baseline and Day 5 (3 hours post last wash procedure)

Secondary Outcomes (5)

• Change From Baseline in Visual Assessment of Redness at Day 5

  At Baseline and Day 5 (3 hours post last wash procedure)

• Change From Baseline in Visual Assessment of Dryness at Day 2, 3, and 4

  At Baseline and Day 2, 3, and 4 (3 hours post last wash procedure)

• Change From Baseline in Visual Assessment of Redness at Day 2, 3, and 4

  At Baseline and Day 2, 3, and 4 (3 hours post last wash procedure)

• Change From Baseline in Transepidermal Water Loss (TEWL) at Day 5

  At Baseline and Day 5 (3 hours post last wash procedure)

• Change From Baseline in Skin Moisturisation at Day 5

  At Baseline and Day 5 (3 hours post last wash procedure)

Study Arms (4)

Test product

OTHER

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

Other: Test Product

Positive Control

OTHER

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.

Other: Positive Control

Negative Control

OTHER

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

Other: Reference Product

No Treatment

OTHER

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

Other: No Treatment

Interventions

Test Product OTHER

Micellar cleanser (0.09 ml)

Test product

Positive Control OTHER

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

Positive Control

Reference Product OTHER

Sterile Water (0.09 ml)

Negative Control

No Treatment OTHER

Unwashed area of the forearm

No Treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (2)

GSK Investigational Site

Campinas, São Paulo, 13084-791, Brazil

Location

GSK Investigational Site

Campinas, São Paulo, 13084-, Brazil

Location

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

• GSK Clinical Trials

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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2017
• First Posted: April 18, 2017
• Study Start: May 8, 2017
• Primary Completion: May 26, 2017
• Study Completion: May 26, 2017
• Last Updated: May 2, 2019
• Results First Posted: May 2, 2019

Record last verified: 2019-01

Locations

BR (2)