To Investigate the Cutaneous and Ocular Local Tolerance o... | NCT03172364

NCT03172364

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Test product 1	Experimental	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
Test product 2	Experimental	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Micellar cleanser	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Frequency of Combined Dermatologist Score	The intensity of any visual signs of irritation was 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 also provided a superficial irritation score if the dermal response score >0. Superficial irritation score was 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 was equal the sum of the dermal response score plus the numerical equivalent of the superficial irritation score. Full range 0-10.	After 21 (+2) days of test product use
Frequency of Combined Ophthalmologist Score	Ocular irritation 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). The combined ophthalmologist score was calculated in the following way: Combined ophthalmologist score = conjunctiva involvement score + lacrimal intensity score. Full range 0-6.	After 21 (+2) days of test product use
Frequency of Combined Dermatologist and Ophthalmologist Score	The combined dermatologist and ophthalmologist score was calculated as the sum of the combined dermatologist score (i.e., dermal response score + superficial irritation score) and the combined ophthalmologist score (i.e., conjunctiva involvement score + lacrimal intensity score). No inferential statistic were performed for this endpoint.The full range was from 0 to 13 where lower scores indicated lower dermal irritation.

Secondary Outcomes

Measure	Description	Time Frame
Frequency of Participant Self-assessment Combined Score for Question Responses With Regards to Product Use Experience on Face	Participants 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 scored 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. Combined score face was obtained by summing the 5 subject assessments for face i.e. redness, dryness, burning, itching and stinging. Maximum observed value of this combined score was 3 and maximum possible combined score was 15. Minimum observed value of this combined score was 0 and minimum possible combined score was 0.

Eligibility Module

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

Name	Affiliation	Role
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

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Campinas	São Paulo	13084-791	Brazil
GSK Investigational Site

ID	Title	Description
FG000	Test Product 1	All the participants in this arm received test product 1 (micellar cleanser) at home twice a day (morning and evening) for 21 (±2) days.
FG001	Test Product 2	All the participants in this arm received test product 2 (micellar foaming cleanser) at home twice a day (morning and evening) for 21 (±2) days.

ID	Title	Description
BG000	Test Product 1	All the participants in this arm received test product 1 (micellar cleanser) at home twice a day (morning and evening) for 21 (±2) days.
BG001	Test Product 2

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type	Title	Description	Population Description	Reporting Status	Anticipated Posting Date	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Time Frame	Units Analyzed	Denominator Units Selected	Arm/Group Information	Denominators	Classes	Analyses
Primary	Frequency of Combined Dermatologist Score	The intensity of any visual signs of irritation was 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 also provided a superficial irritation score if the dermal response score >0. Superficial irritation score was 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 was equal the sum of the dermal response score plus the numerical equivalent of the superficial irritation score. Full range 0-10.	Intent to Treat (ITT, N=113) comprised all randomized subjects who had at least 1 cutaneous or ocular assessment following study product application. No inferential statistic were performed for this outcome.	Posted		Count of Participants		Participants		After 21 (+2) days of test product use

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	May 26, 2017	Jun 20, 2018	Prot_000.pdf
SAP	No	Yes	No	Statistical Analysis Plan	Dec 7, 2017	Jun 20, 2018	SAP_001.pdf

ID	Title	Description
OG000	Test Product 1	All the participants in this arm received test product 1 (micellar cleanser) at home twice a day (morning and evening) for 21 (±2) days.
OG001	Test Product 2	All the participants in this arm received test product 2 (micellar foaming cleanser) at home twice a day (morning and evening) for 21 (±2) days.