A Phase 2, 3 Arm Study of NVN1000 Gel and Vehicle Gel in Subjects With Acne

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novan, Inc.
ClinicalTrials.gov Identifier:
NCT01844752
First received: April 29, 2013
Last updated: January 10, 2014
Last verified: January 2014
  Purpose

This is a 12 week clinical trial in subjects with acne vulgaris. Subjects will be randomized to NVN1000 1% Gel, NVN1000 4% Gel or Vehicle Gel twice daily. Safety, tolerability and efficacy will be assessed over the course of the study.


Condition Intervention Phase
Acne Vulgaris
Drug: NVN1000 1% Gel
Drug: NVN1000 4% Gel
Drug: Vehicle Gel
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multi-Center, Randomized, Evaluator-Blinded, Vehicle-Controlled, Parallel Group, 3-arm Study Comparing the Efficacy, Tolerability and Safety of 2 Concentrations of NVN1000 Gel and Vehicle Gel Twice Daily in the Treatment of Acne Vulgaris.

Resource links provided by NLM:


Further study details as provided by Novan, Inc.:

Primary Outcome Measures:
  • The absolute change from baseline in non-inflammatory lesion counts at Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The absolute change from baseline in non-inflammatory lesion counts at Week 12


Secondary Outcome Measures:
  • The absolute change from baseline in inflammatory lesion counts at Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The absolute change from baseline in inflammatory lesion counts at Week 12

  • Success on the Investigator Global Assessment (IGA) at Week 12 [ Time Frame: 12 week ] [ Designated as safety issue: No ]
    Analysis of the dichotomized IGA scores (success vs failure) at Week 12. "Success" is defined as a score of "clear" or "almost clear" and a 2 point improvement in the IGA score from Baseline.


Enrollment: 153
Study Start Date: April 2013
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NVN1000 1% Gel
NVN1000 1% Gel twice daily
Drug: NVN1000 1% Gel
Twice daily NVN1000 1% Gel for 12 weeks
Experimental: NVN1000 4% Gel
NVN1000 4% Gel twice daily
Drug: NVN1000 4% Gel
Twice daily NVN1000 4% Gel for 12 weeks
Placebo Comparator: Vehicle Gel
Vehicle Gel twice daily
Drug: Vehicle Gel
Twice daily Vehicle Gel for 12 weeks

Detailed Description:

This is a multi-center, evaluator and subject blinded, randomized, vehicle-controlled, parallel group, dose-ranging study to be conducted in approximately 150 subjects with acne vulgaris. Subjects who satisfy the entry criteria at the Baseline visit will be randomized to NVN1000 1% Gel, NVN1000 4% Gel or Vehicle Gel in a 1:1:1 ratio. Efficacy assessments will include inflammatory and non-inflammatory lesion counts and investigator global assessments (IGA). Tolerability and safety assessments include cutaneous tolerability evaluation, adverse event collection, physical exams, and laboratory studies. Subjects will return for post-baseline evaluation at Weeks 2, 4, 8, and 12.

  Eligibility

Ages Eligible for Study:   12 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with acne vulgaris and at least 20 but no more than 40 inflammatory lesions, 25-70 non-inflammatory lesions, no more than 2 nodules on the face
  • Baseline IGA score of mild, moderate or severe
  • Women of child-bearing potential must agree to use an effective method of birth control during the study and for 30 days after their final study visit

Exclusion Criteria:

  • Any dermatologic condition or other medical problem that could interfere with clinical evaluation or requires the use of topical or systemic therapy that make evaluations and lesion count inconclusive
  • Female subjects who are pregnant, nursing, or considering becoming pregnant
  • Methemoglobin > 2% at baseline
  • Clinically significant anemia at baseline
  • Use of topical or systemic medications to treat acne
  • Use of medications that make acne worse, associated with methemoglobinemia, or nitric oxide donors
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01844752

Locations
Dominican Republic
Instituto Dermatologico & Cirugia de Piel
Santo Domingo, Dominican Republic
Honduras
Hospital Y Clinica Bendana
San Pedro Sula, Honduras
Panama
Hosptal Punta Pacifica
Panama City, Panama
Sponsors and Collaborators
Novan, Inc.
Investigators
Study Director: Joyce Rico, MD Novan, Inc.
  More Information

No publications provided

Responsible Party: Novan, Inc.
ClinicalTrials.gov Identifier: NCT01844752     History of Changes
Other Study ID Numbers: NI-AC201
Study First Received: April 29, 2013
Last Updated: January 10, 2014
Health Authority: Honduras: Investigation Committee of Biomedical Ethics

Keywords provided by Novan, Inc.:
acne

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases

ClinicalTrials.gov processed this record on April 17, 2014