Health Condition 1: null- Acne Vulgaris
Conditions
Interventions
Intervention1: Adapalene (0.1%)+ Benzoyl Peroxide (2.5%): Adapalene (0.1%)+ Benzoyl Peroxide (2.5%) topical gel
Control Intervention1: Epiduo?: Adapalene (0.1%) + Benzoyl Peroxide (2.5%) topical gel
Sponsors
Actavis MidAtlantic LLC
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or nonpregnant female patients must be between the ages of 12 and 40 years old inclusive. 2. Patients who are 18 years of age or older must have provided IEC/IRB approved written informed consent. Patients between the ages of 12 to 17 years of age must have provided IEC/IRB approved written assent; this written assent must be accompanied by an IEC/IRB approved written informed consent from the patient?s legally acceptable representative (i.e., parent or guardian). In addition, all patients or their legally acceptable representatives (i.e., parent or guardian) must sign a HIPAA authorization, if applicable. 3. Patients must have a definite clinical diagnosis of mild to severe acne vulgaris (Grade 2, Grade 3 or Grade 4 on the IGE). 4. Patients must have a minimum of 20 inflammatory lesions and a maximum of 100 and a minimum of 25 and a maximum of 100 non-inflammatory lesions (i.e., open and closed comedones) and no more than 2 nodulocystic lesions (i.e., nodules and cysts) at baseline. For the purposes of study treatment and evaluation, these lesions should be limited to the facial treatment area. Lesions involving the eyes, angles of the nose (i.e., the lines around your nostrils and under the nostrils) and scalp should be excluded from the count. Patients may have acne lesions on other areas of the body (e.g., on the back).
Exclusion criteria
Exclusion criteria: 1. Female patients who are pregnant, nursing or planning to become pregnant during study participation (Visit 1 through Visit 5) will be excluded from study participation. 2. Patients who have a known hypersensitivity to benzoyl peroxide, adapalene, and other retinoids, or their excipients will be excluded from study participation. 3. Patients who have conditions that may interfere with the evaluation of acne vulgaris. Such conditions include, but are not limited to the following lesions on the face: rosacea; seborrheic dermatitis; perioral dermatitis; corticosteroid-induced acne or folliculitis; carcinoid syndrome; squamous cell carcinoma; mastocytosis; acneiform eruptions caused by make-up or medication; bacterial folliculitis; facial psoriasis; and facial eczema. 4. Patients who have acne congoblata, acne fulminans, and secondary acne (e.g., chloracne and drug induced acne) will be excluded from participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy measures are (1) the mean percent reduction from baseline to Visit 5 in the inflammatory lesion counts, and (2) the mean percent reduction from baseline to Visit 5 in the non-inflammatory lesion counts. Counts of nodules and cysts should be reported separately and not included in the inflammatory or non-inflammatory lesion counts. Timepoint: 10 to 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary efficacy measures are the proportion of success patients at Visit 5, as measured using the IGE, where success is defined as a 2 grade improvement (e.g., Grade 4 [Severe] to Grade 2 [Mild]) and the mean percent reduction from Visit 1 to Visit 5 in the number of total lesion counts.Timepoint: 10 to 12 months | — |
Countries
Belize, India, United States of America
Contacts
Public ContactDr Jayaveena MN
Outcome results
None listed