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

Study Overview
=================
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.

Official Title
-----------------
A 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

Conditions
-----------------
Skin Care

Intervention / Treatment
-----------------
* Other: Micellar cleanser
* Other: Micellar foaming cleanser


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test product 1<br>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<br>* 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.<br>|
| Experimental: Test product 2<br>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<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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. | After 21 (+2) days of test product use | 
| Combined Dermatologist and Ophthalmologist Score (Modified) | A modified combined dermatologist and ophthalmologist score was calculated, where the superficial irritation component was removed from the equation. Therefore, the modified combined dermatologist and ophthalmologist score was defined as the dermal response score + 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. | After 21 (+2) days of test product use | 

Secondary Outcome Measures

| Outcome Measure | 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. | Baseline and after 21 (+2) days of test product use | 
| Frequency of Participant Self-assessment Combined Score for Question Responses With Regards to Product Use Experience on Eye | 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 eyes?) by using following score: 0= None, 1=Mild, 2= Moderate, and 3= Severe. 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. | Baseline and after 21 (+2) days of test product use |