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

Primary Purpose

Acne Vulgaris, Acne

Status
Completed
Phase
Phase 1
Locations
Dominican Republic
Study Type
Interventional
Intervention
NVN1000
Vehicle
Sponsored by
Novan, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris focused on measuring Acne Vulgaris, Acne

Eligibility Criteria

12 Years - 40 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Instituto Dermatologico

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

NVN1000 Gel

Vehicle Gel

Arm Description

NVN1000 Gel topically applied one daily at bedtime for 8 weeks

Vehicle Gel topically applied once daily at bedtime for 8 weeks

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 14, 2012
Last Updated
November 15, 2018
Sponsor
Novan, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01556698
Brief Title
Study of NVN1000 Topical Gel and Topical Gel Vehicle in the Treatment of Moderate to Severe Acne Vulgaris
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novan, Inc.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris, Acne
Keywords
Acne Vulgaris, Acne

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NVN1000 Gel
Arm Type
Experimental
Arm Description
NVN1000 Gel topically applied one daily at bedtime for 8 weeks
Arm Title
Vehicle Gel
Arm Type
Placebo Comparator
Arm Description
Vehicle Gel topically applied once daily at bedtime for 8 weeks
Intervention Type
Drug
Intervention Name(s)
NVN1000
Other Intervention Name(s)
Nitric Oxide 0.3%
Intervention Type
Drug
Intervention Name(s)
Vehicle
Other Intervention Name(s)
Vehicle Comparator
Intervention Description
Placebo

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daisy Blanco, MD
Organizational Affiliation
Instituto Dermatológico
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Dermatologico
City
Santo Domingo
Country
Dominican Republic

12. IPD Sharing Statement

Learn more about this trial

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

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