Potential Combination Topical Therapy of Acne Vulgaris: a Randomized Controlled Trial Comparing Efficacy of DAP/FLU Micro-emulsion vs. Standard Therapy of Adapalene.
Sponsor study identifier
interventional
20
1 country
1
Study Start
June 5, 2023
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Primary Completion
September 1, 2023
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Study Completion
October 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The investigators propose a randomized, double-blind control trial study to evaluate the efficacy and safety of the optimized topical combination ME of the investigated drugs in the treatment of acne vulgaris containing DAP-FLU in comparison with standard therapy of Adapalene at Mansoura University Dermatology and Andrology Outpatient Clinic.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 3, 2023
Actual (reported)June 5, 2023
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June 12, 2023
Actual (reported)September 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Michaelson's acne severity index (ASI)
It's evaluated by counting non-inflammatory lesions (open and closed comedones) and inflammatory lesions (papules, pustules and nodules of at least 5 mm in diameter), and calculated as follows: ASI = (comedones x 0.5) + (papules x 1) + (pustules x 2) + (nodules x 3).
8 Weeks
Safety assessment by the recording of patient-reported adverse events
Throughout the study
8 Weeks
Acne vulgaris patients treated with the optimized topical combination ME contain DAP-FLU.
Acne vulgaris patients treated with standard therapy of Adapalene.
Combination therapy of topical anti-inflammatory agent (Dapsone 5%) and anti-androgenic agent (Flutamide 2.5%) with anti-bacterial agent of micro-emulsion component (tea tree oil 5%)
Adapalene .1% gel
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Amgad El-Sayed Salem
Al Mansurah, 35516, Egypt
Amgad El-Sayed Salem
Mansoura University
Elham A. Mohamed
Mansoura University
Noha M. Saleh
Mansoura University
Marwa Z. Mubarak
Mansoura University
First Submitted
June 3, 2023
First Posted
June 12, 2023
Study Start
June 5, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
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Galal M. Abdelghania
Mansoura University
September 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
June 13, 2023
Record last verified: 2023-06
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Source: ClinicalTrials.gov.
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