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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 3
- 主要终点
- Frequency of Combined Dermatologist Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Frequency of Combined Dermatologist Score
时间窗: After 21 (+2) days of test product use
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.
Frequency of Combined Ophthalmologist Score
时间窗: After 21 (+2) days of test product use
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.
Frequency of Combined Dermatologist and Ophthalmologist Score
时间窗: After 21 (+2) days of test product use
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.
Combined Dermatologist and Ophthalmologist Score (Modified)
时间窗: After 21 (+2) days of test product use
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.
次要结局
- Frequency of Participant Self-assessment Combined Score for Question Responses With Regards to Product Use Experience on Face(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(Baseline and after 21 (+2) days of test product use)