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

NCT ID: NCT01556698

Last Updated: 2018-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2011-12-31

Brief Summary

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.

Detailed 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.

Conditions

Acne Vulgaris; Acne

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

NVN1000 Gel

NVN1000 Gel topically applied one daily at bedtime for 8 weeks

Group Type: EXPERIMENTAL

NVN1000

Intervention Type: DRUG

Vehicle Gel

Vehicle Gel topically applied once daily at bedtime for 8 weeks

Group Type: PLACEBO_COMPARATOR

Vehicle

Intervention Type: DRUG

Placebo

Interventions

NVN1000

Intervention Type: DRUG

Vehicle

Placebo

Intervention Type: DRUG

Other Intervention Names

Nitric Oxide 0.3%; Vehicle Comparator

Eligibility Criteria

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novan, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daisy Blanco, MD

Role: PRINCIPAL_INVESTIGATOR

Instituto Dermatológico

Locations

Instituto Dermatologico

Santo Domingo, , Dominican Republic

Countries

Dominican Republic

Other Identifiers

NI-AC001

Identifier Type: -

Identifier Source: org_study_id