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

Acne Vulgaris Clinical Trial

Official title:

Single-Center, Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Comparison, Proof of Concept Study Comparing the Tolerability, Safety and Efficacy of NVN1000 Topical Gel Gel Vehicle in the Treatment of Moderate to Severe Acne

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01556698
• Other study ID #: NI-AC001
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: July 2011
• Est. completion date: December 2011

Study information

• Verified date: November 2018
• Source: Novan, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Acne
• Acne Vulgaris

Intervention

Drug:
• NVN1000

• Vehicle
Placebo

Locations

Country	Name	City	State
Dominican Republic	Instituto Dermatologico	Santo Domingo

Sponsors (1)

Lead Sponsor	Collaborator
Novan, Inc.

Country where clinical trial is conducted

Dominican Republic,