Acne Vulgaris
Conditions
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.
Interventions
DRUGDAP-FLU ME
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%)
DRUGAdapalene .1% gel
Adapalene .1% gel
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male and females age 12 or older 2. Clinical diagnosis of mild to moderate facial acne vulgaris defined as: 1. ≥ 5 inflammatory lesions, and; 2. ≥ 10 non-inflammatory lesions, and; 3. IGA 2-3 3. 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. 4. Willing and able to provide informed consent and to comply with the study protocol.
Exclusion criteria
1. Women were excluded if they were pregnant, nursing, or planning a pregnancy as were men with facial hair that would interfere with the assessments. 2. Continuous or planned use of tanning booths or excessive sun exposure, in the opinion of the Investigator. 3. Treatment with systemic corticosteroids within 28 days prior to baseline. 4. Two or more active nodular lesions. 5. Use of androgen receptor blockers (such as spironolactone or flutamide) in the 7 days prior to randomization.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Michaelson's acne severity index (ASI) | 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). |
| Safety assessment by the recording of patient-reported adverse events | 8 Weeks | Throughout the study |
Countries
Egypt
Contacts
Primary ContactAmgad El-Sayed Salem
Backup ContactMarwa Z. Mubarak
Outcome results
None listed