Safety and Tolerability of Acanya Gel in Combination With... | NCT01448733

NCT01448733

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Acanya Plus Atralin	Experimental	A single, open-label arm treating acne with Cerave lotion plus Acanya gel in the morning in combination with Cerave lotion plus Atralin gel in the evening.	Drug: Benzoyl peroxide 2.5%/clindamycin phosphate 1.2% in the morning with with tretinoin 0.05% gel in the evening

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Benzoyl peroxide 2.5%/clindamycin phosphate 1.2% in the morning with with tretinoin 0.05% gel in the evening	Drug	Green pea sized amount of Benzoyl peroxide 2.5%/clindamycin phosphate 1.2% in the morning in combination with a green pea sized amount of tretinoin 0.05% gel in the evening

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cutaneous Tolerability of Combination Therapy of Acanya Gel with Atralin Gel for the treatment of acne vulgaris	Evaluation of skin erythema, scaling, drying, and stinging/burning	12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Efficacy of Combination Therapy of Acanya Gel with Atralin Gel for the treatment of acne vulgaris	Evaluation of efficacy as defined as a global assessment of clear or almost clear after 12 weeks of therapy.	12 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Males and females ≥ 12 years old.
Subjects must be in good general health as confirmed by medical history and physical examination.
Females of child-bearing potential must have a negative urine pregnancy test at the baseline visit and agree to be abstinent or use adequate birth control during the study (oral contraceptives, Norplant, Depo-Provera, or double barrier methods (e.g., condom and spermicide).
Clear diagnosis of facial acne vulgaris for at least 6 months.
Subject must have a static Physician's Global Assessment (PGA) of 2 (mild severity) or 3 (moderate severity).
Disease must be stable or slowly worsening for more than one week prior to entering the study.
Subjects or their guardians must be able to read, sign, and date the informed consent, and abide by study restrictions for its duration.

Exclusion Criteria:

Females who are pregnant, attempting to conceive, or breastfeeding.
Subjects with known hypersensitivity to any ingredients in the study drugs.
Subjects with overt signs of skin atrophy, telangiectasias or other skin findings that would affect efficacy evaluation.
Subjects with a current active skin malignancy or infection.
Subjects requiring the use of medications known to alter the course of acne vulgaris during the study treatment.
Subjects who have received systemic antibiotics within 2 weeks.
Subjects using systemic corticosteroids or immunosuppressants within 28 days of entering the study.
Subjects who have received any topical therapies for acne vulgaris within 7 days of entering the study.
Subjects taking birth control pills used solely for acne control.
Subjects who are currently participating in or, within the previous 28 days, have participated in another study for the treatment of acne vulgaris.
Subjects with clinical conditions that may post a health risk to the subject by being involved in the study or detrimentally affect regular follow-up of the subject.
Subjects who have Crohn's disease, colitis, or if subjects ever developed colitis or severe diarrhea with past antibiotic use.

ID	Term
D017486	Acneiform Eruptions
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D012625	Sebaceous Gland Diseases