Clinical trial NCT03172364: To Investigate the Cutaneous and Ocular Local Tolerance of Two Cosmetic Facial Cleanser in Healthy Females With 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Care
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2017-06-01
Enrollment: 122
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Frequency of Combined Dermatologist Score
timeFrame: After 21 (+2) days of test product use
measure: Frequency of Combined Ophthalmologist Score
timeFrame: After 21 (+2) days of test product use
measure: Frequency of Combined Dermatologist and Ophthalmologist Score
timeFrame: After 21 (+2) days of test product use
measure: Combined Dermatologist and Ophthalmologist Score (Modified)
timeFrame: After 21 (+2) days of test product use
Secondary outcomes:
measure: Frequency of Participant Self-assessment Combined Score for Question Responses With Regards to Product Use Experience on Face
timeFrame: Baseline and after 21 (+2) days of test product use
measure: Frequency of Participant Self-assessment Combined Score for Question Responses With Regards to Product Use Experience on Eye
timeFrame: Baseline and after 21 (+2) days of test product use
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: GSK Investigational Site
state: São Paulo
city: Campinas
country: Brazil
facility: GSK Investigational Site
state: São Paulo
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
affiliation: GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: