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

Acne Vulgaris Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01844752
• Other study ID #: NI-AC201
• Status: Completed
• Phase: Phase 2
• Start date: April 2013
• Est. completion date: November 2013

Study information

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

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• NVN1000 1% Gel
Twice daily NVN1000 1% Gel for 12 weeks
• NVN1000 4% Gel
Twice daily NVN1000 4% Gel for 12 weeks
• Vehicle Gel
Twice daily Vehicle Gel for 12 weeks

Locations

Country	Name	City	State
Dominican Republic	Instituto Dermatologico & Cirugia de Piel	Santo Domingo
Honduras	Hospital Y Clinica Bendana	San Pedro Sula
Panama	Hosptal Punta Pacifica	Panama City

Sponsors (1)

Lead Sponsor	Collaborator
Novan, Inc.

Countries where clinical trial is conducted

Dominican Republic,  Honduras,  Panama, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The absolute change from baseline in non-inflammatory lesion counts at Week 12	The absolute change from baseline in non-inflammatory lesion counts at Week 12	12 weeks
Secondary	The absolute change from baseline in inflammatory lesion counts at Week 12	The absolute change from baseline in inflammatory lesion counts at Week 12	12 weeks
Secondary	Success on the Investigator Global Assessment (IGA) at Week 12	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.	12 week