Clinical Trial To Evaluate ANT-1207 In Subjects With Acne

Anterios

Status and phase: Completed; Phase 2

Conditions: Acne Vulgaris

Treatments: Biological: ANT-1207; Biological: Vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT01293552

ANT-1207-101-ACNE

Details and patient eligibility

About

The purpose of this study is to provide evidence of the safety, tolerance, and efficacy of ANT-1207 in the treatment of acne.

Enrollment: 72 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diagnosis of moderate to severe facial acne
• 15 to 40 papules and pustules, and 5 to 50 open and/or closed comedones
• no presence of nodules
• female subjects must be not pregnant and non-lactating

Exclusion criteria

• presence of 1 or more nodules
• use of topical steroids on the face 4 weeks prior and during the study
• use of systemic corticosteroids 6 weeks prior and during the study
• topical or systemic acne treatment in the 4 weeks prior to Baseline

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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72 participants in 5 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

blank vehicle formulation

Treatment:

Biological: Vehicle

Dose 1

Experimental group

Description:

Dose 1

Treatment:

Biological: ANT-1207

Dose 2

Experimental group

Description:

Dose 2

Treatment:

Biological: ANT-1207

Dose 3

Experimental group

Description:

Dose 3

Treatment:

Biological: ANT-1207

Dose 4

Experimental group

Description:

Dose 4

Treatment:

Biological: ANT-1207