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

ID: NCT03172364
Status: Completed
Phase: N/A
Start Date: June 12, 2017
First Submitted: May 29, 2017
Last Updated: February 22, 2018
Results: N/A
Organization: GlaxoSmithKline
Sponsors & Collaborators: GlaxoSmithKline
Location: Brazil
Conditions: Skin Care
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Study Description

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.
Condition or disease Intervention/treatment Phase

Skin Care

Other: Micellar cleanser
Other Names
Other: Micellar foaming cleanser
Other Names
N/A

Tracking Information

First Submitted DateMay 29, 2017
Last Update Posted DateFebruary 22, 2018
Actual Start DateJune 12, 2017
Actual Completion DateJuly 13, 2017
Actual Primary Completion DateJuly 13, 2017
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Dermatologist Visual assessment of cutaneous irritation [Time Frame: After 21 (+2) days of test product use]

    The intensity of any visual signs of irritation will be recorded according to Dermal response score: 0=No evidence of irritation, 1=Minimal erythema; barely perceptible, 2=Definite erythema, readily visible; or minimal edema; or minimal popular response, 3=Erythema and papules, 4=Definite edema, 5=Erythema, edema, and papules, 6=Vesicular eruption, and 7=Strong reaction spreading beyond test site. Dermatologist will also provide a superficial irritation score if the dermal response score >0. Superficial irritation score are as follow: grade A/score 0=Slight glazed appearance, grade B/score 1=Marked glazing, grade C/score 2=Glazing with peeling and cracking, grade F/score 3=Glazing with fissures, grade G/score 3=Film of dried serous exudate covering all or portion of the patch, and grade H/score 3=Small petechial erosions and/or scabs. The combined score will equal the sum of the dermal response score plus the numerical equivalent of the superficial irritation score.

  • Ophthalmologist Visual assessment of ocular irritation [Time Frame: After 21 (+2) days of test product use]

    Ocular irritation will be assessed through the observation of the presence of two factors: Lacrimation Intensity and Conjunctiva Involvement. Conjunctiva involvement score are as follow: 0= None - No involvement, 1= Mild - Conjunctivae (palpebral and bulbar) injected above normal with possible chemosis (swelling); no discharge, 2= Moderate - Conjunctivae injected above normal; obvious swelling; possible discharge, and 3= Severe - Conjunctivae more diffuse, deeper crimson red, individual vessels not easily discernible; excessive swelling and/or discharge. Lacrimal intensity score are as follow: 0= None - No lacrimation observed, 1= Mild-Excessive wetness (no distinct tears), 2= Moderate - A few formed tears (contained in orbit), and 3= Severe - Intense tearing (leaving orbit).

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • Participant self-assessment question responses with regards to product use experience on face [Time Frame: Baseline and after 21 (+2) days of test product use]

    Participants will be asked Subject Self-Assessment questions at Baseline (Visit 2), prior to test product use, 1 hour (± 20 minutes) following first supervised product use, and following 21 (+2) days of product use. Participants will score each symptom asked in the question (Are you experiencing any redness, dryness, burning, itching or stinging of your face?) by using following score: 0= None, 1=Mild, 2= Moderate, and 3= Severe.

  • Participant self-assessment question responses with regards to product use experience around the eyes [Time Frame: Baseline and after 21 (+2) days of test product use]

    Participants will be asked Subject Self-Assessment questions at Baseline (Visit 2), prior to test product use, 1 hour (± 20 minutes) following first supervised product use, and following 21 (+2) days of product use. Participants will score each symptom asked in the question (Are you experiencing any redness, dryness, burning, itching or stinging of your eyes?) by using following score: 0= None, 1=Mild, 2= Moderate, and 3= Severe.

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleTo Investigate the Cutaneous and Ocular Local Tolerance of Two Cosmetic Facial Cleanser in Healthy Females With Sensitive Skin
Official TitleA Clinical Study to Assess the Cutaneous and Ocular Local Tolerance of Two Cosmetic Facial Cleansers in Healthy Females With Sensitive Skin Under Normal Conditions of Use
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.

Study TypeInterventional
Study PhaseN/A
Estimated Enrollment
113
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Single
Primary Purpose
Basic Science
Conditions
Skin Care
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Other: 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.

Other Names
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.

Other Names
Study Groups/Cohorts
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.

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.

Study Arms
Experimental 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.
Other : 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.

Experimental 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.
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.

Arm Intervention/Treatment
Experimental 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.
Other : Micellar cleanser
Experimental 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.
Other : Micellar foaming cleanser

Recruitment Information

Recruitment Status:Completed
Enrollment113
Completion DateJuly 13, 2017
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
GenderFemale
Age18 Years to 65 Years
Accepts Healthy VolunteersAccepts Healthy Volunteers
Contacts
Not Available
Listed Location Countries
Brazil

Administrative Information

NCT Number:NCT03172364
Other Study ID Numbers
207782
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
GlaxoSmithKline
Collaborators
Not Available
Investigators
Study Director
GSK Clinical Trials
GlaxoSmithKline