Study of NVN1000 Topical Gel and Topical Gel Vehicle in the Treatment of Moderate to Severe Acne Vulgaris

Novan

Status and phase: Completed; Phase 2; Phase 1

Conditions: Acne; Acne Vulgaris

Treatments: Drug: Vehicle; Drug: NVN1000

Study type: Interventional

Funder types: Industry

Identifiers

NCT01556698

NI-AC001

Details and patient eligibility

About

The primary objective of this study is to compare the tolerability, safety and efficacy of NVN1000 Topical Gel and Topical Gel Vehicle in the treatment of subjects with moderate to severe acne vulgaris.

Full description

The objective of this study is to evaluate the tolerability, safety and efficacy of once daily application of NVN1000 Topical Gel for 8 weeks in comparison with its vehicle in subjects with moderate to severe acne.

Enrollment: 70 patients

Sex: All

Ages: 12 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Baseline IGA score of moderate (3) or severe (4)
• Minimum of 20 but no more than 40 facial inflammatory lesions
• Minimum of 20 but not more than 60 facial non-inflammatory lesions
• No more than 2 facial nodules

Exclusion criteria

• Dermatological conditions on the face that could interfere with clinical evaluations
• Underlying disease(s) or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion count inconclusive
• History of experiencing significant burning or stinging when applying any facial treatment
• Female subjects, if they are pregnant,nursing mothers, or planning to become pregnant during the study
• Have used estrogens or oral contraceptives for less than 90 days immediately preceding the Baseline visit, discontinued use of estrogens or oral contraceptives less than 90 days prior to Baseline,or planning to begin or discontinue use of this therapy during the treatment period
• Have used medications and/or vitamins which are reported to exacerbate acne during the 180 days immediately preceding the Baseline visit
• Use concomitantly over-the-counter (OTC) products that contain ingredients such as benzoyl peroxide,salicylic acid,alpha-hydroxy acid,retinol or glycolic acids
• Have not undergone the specified washouts for topical preparations,systemic medications and procedures noted in the protocol

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

70 participants in 2 patient groups, including a placebo group

NVN1000 Gel

Experimental group

Description:

NVN1000 Gel topically applied one daily at bedtime for 8 weeks

Treatment:

Drug: NVN1000

Vehicle Gel

Placebo Comparator group

Description:

Vehicle Gel topically applied once daily at bedtime for 8 weeks

Treatment:

Drug: Vehicle