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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Facial Dermatoses
Sebaceous Gland Diseases
Skin Diseases

ClinicalTrials.gov processed this record on November 20, 2014