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

NCT01556698 | Completed Phase 1

• 1 other identifier: NI-AC001
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Acne Vulgaris; Acne

Keywords

Acne Vulgaris; Acne

Study Arms (2)

NVN1000 Gel

EXPERIMENTAL

NVN1000 Gel topically applied one daily at bedtime for 8 weeks

Drug: NVN1000

Vehicle Gel

PLACEBO COMPARATOR

Vehicle Gel topically applied once daily at bedtime for 8 weeks

Drug: Vehicle

Interventions

NVN1000 DRUG

Also known as: Nitric Oxide 0.3%

NVN1000 Gel

Vehicle DRUG

Placebo

Also known as: Vehicle Comparator

Vehicle Gel

Eligibility Criteria

• Age: 12 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novan, Inc.: lead

Study Sites (1)

Instituto Dermatologico

Santo Domingo, Dominican Republic

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

berdazimer sodium

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Officials

• Daisy Blanco, MD

  Instituto Dermatológico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2012
• First Posted: March 16, 2012
• Study Start: July 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: November 19, 2018

Record last verified: 2018-11

Locations

DO (1)