To Investigate the Cutaneous and Ocular Local Tolerance of Two Cosmetic Facial Cleanser in Healthy Females With Sensitive Skin

NCT ID: NCT03172364

Last Updated: 2019-04-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 122 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-12
• Study Completion Date: 2017-07-13

Brief Summary

The objective of this clinical study is to assess the cutaneous and ocular local tolerance of two cosmetic facial cleansers in healthy female participants with sensitive skin under normal conditions of use.

Detailed Description

This is an assessor blind (dermatologist and ophthalmologist) clinical in use study to determine the local cutaneous and ocular tolerance of two cosmetic facial cleanser products when used as per the intended instructions for use in a population of healthy female participants with clinically assessed sensitive skin.

Conditions

Skin Care

Study Design

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

Study Groups

Test product 1

All the participants in this arm will receive test product 1 (micellar cleanser) at home twice a day (morning and evening) for 21 (±2) days.

Group Type: EXPERIMENTAL

Micellar cleanser

Intervention Type: OTHER

Participants will apply the micellar cleanser topically twice a day (morning and evening). Micellar cleanser will be applied on cotton pad and wiped over the entire face and closed eye to gently cleanse. No need to rub or rinse the micellar cleanser.

Test product 2

All the participants in this arm will receive test product 2 (micellar foaming cleanser) at home twice a day (morning and evening) for 21 (±2) days.

Group Type: EXPERIMENTAL

Micellar foaming cleanser

Intervention Type: OTHER

Participants will use the micellar foaming cleanser topically twice a day (morning and evening). Micellar foaming cleanser will be massaged gently onto wet skin on the face using fingertips. After which participants will rinse thoroughly and pat the skin dry.

Interventions

Micellar cleanser

Participants will apply the micellar cleanser topically twice a day (morning and evening). Micellar cleanser will be applied on cotton pad and wiped over the entire face and closed eye to gently cleanse. No need to rub or rinse the micellar cleanser.

Intervention Type: OTHER

Micellar foaming cleanser

Participants will use the micellar foaming cleanser topically twice a day (morning and evening). Micellar foaming cleanser will be massaged gently onto wet skin on the face using fingertips. After which participants will rinse thoroughly and pat the skin dry.

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
• 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 (dermatologist or ophthalmologist) examination
• Fitzpatrick phototype I to IV
• Sensitive Skin (as determined by the lactic acid Stinging test)
• Dermatologist score of zero
• Ophthalmologist score of zero
• Dermatologist assessed Dry or Normal/Combination Skin
• Agreement to comply with the procedures and requirements of the study and to attend the scheduled assessment visits
• Frequent use of facial cosmetic make-up, including eye-make-up (5 out of 7 days per week)

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
• 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 up to 2 weeks before screening visit and during the study
• Oral or topical treatment with vitamin A acid and/or its derivatives up to 1 month before the screening visit and during the study
• 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 Screening visit, or expects to begin injections during study participation
• Previous history of atopy with regards to 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
• Any participant who, in the judgment of the Investigator, should not participate in the study
• Any participant with corneal ulcers, keratoconus, blepharitis, meibomitis, pterygium, chemosis, moderately or severe hyperemia or other active ocular diseases
• Any skin marks on the face 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
• Participant with a qualified dermatologist assessment of oily skin
• 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: FEMALE
• 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

207782

Identifier Type: -

Identifier Source: org_study_id