The objective of this study is to evaluate the tolerance and efficacy of a facial moisturizer in subjects with mild to moderate acne vulgaris over a 4-week treatment period.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
47
Subjects will use the facial moisturizer for 4 weeks according to the following: Apply evenly to your face and neck once daily (or twice daily, if desired) after washing your face with your regularly used facial cleanser for the duration of the study. Record all product applications in the daily diary.
TKL Research Inc. - Fair Lawn
Fair Lawn, New Jersey, United States
Investigator's assessment of efficacy
The Investigator or the expert grader observed efficacy parameters like Visual Dryness, Tactile Surface Roughness, Lack of Radiance/Brightness, Global Fine Lines, Overall Appearance of Pores, Overall Skin Appearance, Skin Blotchiness, Uneven Skin Tone, Lack of Skin Clarity using a 10-point ordinal scale (0=none, 1-3 = mild, 4-6 = moderate, 7-9 = severe). A decrease in score compared to baseline indicates an improvement in the efficacy parameter.
Time frame: Visit 1 (Screening/Baseline: pre-product use), Visit 2 (Week 1) and Visit 3 (Week 4)
Acne Quality of Life Index (AQOLI) 3 Domains and Group Total Scores
Subjects will complete an Acne Quality of Life Index \[Acne-QOLI\] using a 1 to 7 scale (1 = extremely, 4 = some, 7 = not at all). A decrease in scores indicates improvement.
Time frame: Visit 1 (Screening/Baseline: pre-product use) and Visit 3 (Week 4)
VISIA Imaging
Full-face digital images will be taken using the site provided VISIA-CR 5 photographic imaging system.
Time frame: Visit 1 (Screening/Baseline: pre-product use) and Visit 3 (Week 4)
Investigator's assessment of tolerability
The Investigator will perform a clinical evaluation of each subject's neck and facial skin of Erythema, Edema, Dryness/Scaling, Rash/Irritation using a 4-point ordinal scale (0=none; 1=Mild; 2=Moderate; 3=Severe). A decrease in score compared to baseline indicates an improvement in the efficacy parameter.
Time frame: Visit 1 (Screening/Baseline: pre-product use),Visit 2(Week 1) and Visit 3 (Week 4)
Subjects' assessment of tolerability
The Investigator will question each subject for the parameters below regarding the subject's neck and facial skin of Burning, Stinging, Tightness/Dry Feeling , Itching , Peeling/Flaking, Overall sensitivity. Assessments will be scored on a 4-point ordinal scale (0=none; 1=Mild; 2=Moderate; 3=Severe). A decrease in score compared to baseline indicates an improvement in the efficacy parameter.
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Time frame: Visit 1 (Screening/Baseline: pre-product use), Visit 2 (Week 1), and Visit 3 (Week 4)
Subjective assessment of efficacy Part A
Self-assessment regarding the current condition (Appearance of redness associated with pimples, Oiliness of skin, Shininess of skin, Dryness of skin, Flakiness of skin, Skin smoothness, Appearance of pores, Redness of skin, Overall appearance of skin) of facial skin using a 1-10 scale. A decrease in score indicates an improvement in the efficacy parameter.
Time frame: Visit 1 (Screening/Baseline: pre-product use), Visit 2 (Week 1) and Visit 3 (Week 4)
Subjective assessment of efficacy Part B
Self-assessment on efficacy at post product use timepoint. Frequency and percentage of all answers for all questions, and a binomial test (sign test) p-value will be provided for applicable questions. A higher percentage of favorable responses with a significant p-value indicates positive subject perceptions of the IP.
Time frame: Visit 1 (Post product use), Visit 2 (Week 1) and Visit 3 (Week 4)