A Dose-Ranging Study Evaluating the Safety and Efficacy of IDP-107 in Patients With Acne Vulgaris

Dova Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Acne Vulgaris

Treatments: Drug: High Strength IDP-107; Drug: Placebo; Drug: Low Strength IDP-107

Study type: Interventional

Funder types: Industry

Identifiers

NCT01194375

DPSI-IDP-107-P2-02

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of IDP-107 versus placebo in treating patients with acne vulgaris.

Enrollment: 180 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Presence of acne vulgaris on the face and neck/trunk
• Presence of inflammatory and non-inflammatory lesions on the face

Exclusion criteria

• Presence of any skin condition on the face that could interfere with clinical evaluations
• Use of any systemic antibiotics or corticosteroids within 4 weeks prior to the Baseline visit
• Use of any systemic retinoids, such as isotretinoin, within 3 months prior to the Baseline visit
• Woman who is pregnant, nursing an infant, or planning a pregnancy during the study period

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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180 participants in 3 patient groups, including a placebo group

Low Strength IDP-107

Experimental group

Treatment:

Drug: Low Strength IDP-107

High Strength IDP-107

Experimental group

Treatment:

Drug: High Strength IDP-107

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo