To assess facial acne vulgaris clinical and psychological outcomes by measuring differences in lesions counts, investigator global assessment, and subjects quality of life scores over 6 months in adult females treated with Next Science™ acne cream 2x or Next Science™ acne cream 1x in a double blind manner.
This is a 6-month, single-site, double-blind, controlled study in 20 female subjects with mild to moderate facial acne. Subjects will be randomized 1:1 to apply either topical Next Science™ acne cream 2x or Next Science™ acne cream 1x daily. Subjects will be evaluated for clinical acne and quality of life outcomes at baseline, 6, 12, 18 and 24 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
2
Twice daily application of facial acne cream 2X after facial cleansing
Twice daily application of facial acne cream 1X after facial cleansing
Skin Laser & Surgery Specialists of NY & NJ
Hackensack, New Jersey, United States
Reduction in Lesion Count
Inflammatory acne lesions with both study acne cream products after 6 months of treatment compared to baseline. This will be measured as the mean percent change from baseline to week 24 in the inflammatory lesion count.
Time frame: Baseline versus 6 months
Inflammatory Lesion count over time
to assess the mean percent change from baseline to weeks 6, 12, 18, and 24 inflammatory lesion counts
Time frame: weeks 6, 12, 18, and 24
Non-inflammatory acne lesion over time
to assess the mean percent change from baseline to weeks 6, 12, 18, and 24 in non-inflammatory lesion counts
Time frame: weeks 6, 12, 18, and 24
Investigator Global Assessment over time
to assess the mean percent change from baseline to weeks 6, 12, 18, and 24 in IGA
Time frame: weeks 6, 12, 18, and 24
Treatment Areas over time
to assess the mean percent change from baseline to weeks 6, 12, 18, and 24 in treatment areas (erythema, dryness, stinging or burning, erosion, edema, pain and itching)
Time frame: weeks 6, 12, 18, and 24
Quality of Life over time
The Acne-QoL questionnaire containing 19 questions organized into four domains which address the impact of facial acne on health-related quality of life will be administered. These are Self Perception, Role-social, Role-emotional and Acne Symptoms. Results will assess the mean percent change from baseline to weeks 6, 12, 18, and 24 in QoL.
Time frame: weeks 6, 12, 18, and 24
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