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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DAP/FLU ME | Experimental | Acne vulgaris patients treated with the optimized topical combination ME contain DAP-FLU. |
|
| Adapalene .1% gel | Active Comparator | Acne vulgaris patients treated with standard therapy of Adapalene. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DAP-FLU ME | Drug | 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%) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Male and females age 12 or older
Clinical diagnosis of mild to moderate facial acne vulgaris defined as:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amgad El-Sayed Salem | Contact | +201099805564 | amgadsalem@mans.edu.eg | |
| Marwa Z. Mubarak | Contact | +201069910843 |
| Name | Affiliation | Role |
|---|---|---|
| Amgad El-Sayed Salem | Mansoura University | Study Director |
| Elham A. Mohamed | Mansoura University | Study Director |
| Noha M. Saleh |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amgad El-Sayed Salem | Al Mansurah | 35516 | Egypt |
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| ID | Term |
|---|---|
| D000068816 | Adapalene |
| D005782 | Gels |
| ID | Term |
|---|---|
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Adapalene .1% gel | Drug | Adapalene .1% gel |
|
| Mansoura University |
| Study Director |
| Marwa Z. Mubarak | Mansoura University | Study Director |
| Galal M. Abdelghania | Mansoura University | Principal Investigator |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |