Potential Combination Topical Therapy of Acne Vulgaris: a Randomized Controlled Trial Comparing Efficacy of DAP/FLU Micro-emulsion vs. Standard Therapy of Adapalene.
Overview
- Phase
- Phase 2
- Intervention
- Adapalene .1% gel
- Conditions
- Acne Vulgaris
- Sponsor
- Mansoura University
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Safety assessment by the recording of patient-reported adverse events
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Investigators
Amgad E Salem, pHD
Assistant lecturer, pharmaceutical department, faculty of pharmacy
Mansoura University
Eligibility Criteria
Inclusion Criteria
- •Male and females age 12 or older
- •Clinical diagnosis of mild to moderate facial acne vulgaris defined as:
- •≥ 5 inflammatory lesions, and;
- •≥ 10 non-inflammatory lesions, and;
- •Willing to refrain from using any treatments, other than the investigational product, for acne present on the face. This includes the use of antibiotics for the treatment of acne.
- •Willing and able to provide informed consent and to comply with the study protocol.
Exclusion Criteria
- •Women were excluded if they were pregnant, nursing, or planning a pregnancy as were men with facial hair that would interfere with the assessments.
- •Continuous or planned use of tanning booths or excessive sun exposure, in the opinion of the Investigator.
- •Treatment with systemic corticosteroids within 28 days prior to baseline.
- •Two or more active nodular lesions.
- •Use of androgen receptor blockers (such as spironolactone or flutamide) in the 7 days prior to randomization.
Arms & Interventions
Adapalene .1% gel
Acne vulgaris patients treated with standard therapy of Adapalene.
Intervention: Adapalene .1% gel
DAP/FLU ME
Acne vulgaris patients treated with the optimized topical combination ME contain DAP-FLU.
Intervention: DAP-FLU ME
Outcomes
Primary Outcomes
Safety assessment by the recording of patient-reported adverse events
Time Frame: 8 Weeks
Throughout the study
Michaelson's acne severity index (ASI)
Time Frame: 8 Weeks
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).