Clinical Trial: Six Months Evaluation of Next Science Acne Creams on Facial Acne in Adult Females.

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Single-center, Double-blind, Controlled Study to Evaluate the Effect of Next Science™ Acne Cream on Mild to Moderate Facial Acne in Adult Females Over 6 Months.

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: Next Science TM

Current Primary Outcome: Reduction in Lesion Count [ Time Frame: Baseline versus 6 months ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Inflammatory Lesion count over time [ Time Frame: weeks 6, 12, 18, and 24 ]
    to assess the mean percent change from baseline to weeks 6, 12, 18, and 24 inflammatory lesion counts
  • Non-inflammatory acne lesion over time [ Time Frame: weeks 6, 12, 18, and 24 ]
    to assess the mean percent change from baseline to weeks 6, 12, 18, and 24 in non-inflammatory lesion counts
  • Investigator Global Assessment over time [ Time Frame: weeks 6, 12, 18, and 24 ]
    to assess the mean percent change from baseline to weeks 6, 12, 18, and 24 in IGA
  • Treatment Areas over time [ Time Frame: weeks 6, 12, 18, and 24 ]
    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)
  • Quality of Life over time [ Time Frame: weeks 6, 12, 18, and 24 ]
    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.


Original Secondary Outcome: Same as current

Information By: Next Science TM

Dates:
Date Received: March 27, 2017
Date Started: March 27, 2017
Date Completion: March 2018
Last Updated: April 4, 2017
Last Verified: April 2017