Clinical trial NCT01844752: A Phase 2, 3 Arm Study of NVN1000 Gel and Vehicle Gel in Subjects With Acne
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acne Vulgaris
Keywords: acne
Lead sponsor: Novan, Inc.
Sponsor class: INDUSTRY
First posted: 2013-05-01
Enrollment: 153
Sex: ALL
Minimum age (years): 12
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: The absolute change from baseline in non-inflammatory lesion counts at Week 12
timeFrame: 12 weeks
Secondary outcomes:
measure: The absolute change from baseline in inflammatory lesion counts at Week 12
timeFrame: 12 weeks
measure: Success on the Investigator Global Assessment (IGA) at Week 12
timeFrame: 12 week
Other outcomes:
Locations:
city: Santo Domingo
country: Dominican Republic
facility: Instituto Dermatologico & Cirugia de Piel
city: San Pedro Sula
country: Honduras
facility: Hospital Y Clinica Bendana
city: Panama City
country: Panama
facility: Hosptal Punta Pacifica
Study officials:
affiliation: Novan, Inc.
name: Joyce Rico, MD
role: STUDY_DIRECTOR
References:
citation: Baldwin H, Blanco D, McKeever C, Paz N, Vasquez YN, Quiring J, Enloe C, De Leon E, Stasko N. Results of a Phase 2 Efficacy and Safety Study with SB204, an Investigational Topical Nitric Oxide-releasing Drug for the Treatment of Acne Vulgaris. J Clin Aesthet Dermatol. 2016 Aug;9(8):12-8. Epub 2016 Aug 1.