A Phase 1 Study Evaluating Safety and Tolerability of NVN1000 Gel

Novan

Status and phase: Completed; Phase 1

Conditions: Acne Vulgaris

Treatments: Drug: NVN1000 4% Gel; Drug: Vehicle Gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT01844739

NI-AC006

Details and patient eligibility

About

This is a 2 week Phase 1 study of SB204 (NVN1000 Gel) in healthy adult volunteers with elevated Propionibacterium acnes (P. acnes) counts. Subjects will apply NVN1000 4% Gel or Vehicle Gel twice daily to their face. Assessments will include cutaneous tolerability, safety, and P. acnes counts.

Full description

In this single-center, vehicle gel-controlled, evaluator and subject blinded study, approximately 30 otherwise healthy adult subjects with elevated P. acnes counts will be randomized 2:1 to NVN1000 4% Gel or Vehicle Gel. The subjects will apply the test material twice daily to their face after washing. Subjects will be seen daily at the skin study center during the week and will apply their evening and weekend dose at home. Cutaneous tolerability will be assessed by the Investigator at Baseline, Week 1, and Week 2. Safety assessments include collection of adverse events, laboratory results, and clinically significant changes in physical examination. P. acnes counts will be obtained at Baseline, Week 1 and Week 2.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy adult male or female volunteers
• If a woman of child-bearing potential, agrees to use effective method of birth control during the study and for 30 days after the final study visit
• Agree to refrain from use of antimicrobial topical products during study

Exclusion criteria

• Any skin disorders of acute or chronic nature including psoriasis, eczema, etc
• Female subjects who are pregnant, nursing, or planning to become pregnant
• Subjects who have used topical or systemic antibiotics, estrogens, drugs associated with methemoglobinemia, nitrate donors
• Subjects with baseline methemoglobin > 2%
• Subjects with clinically significant anemia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

30 participants in 2 patient groups, including a placebo group

NVN1000 4% Gel

Experimental group

Description:

NVN1000 4% Gel twice daily to the face for 2 weeks

Treatment:

Drug: NVN1000 4% Gel

Vehicle Gel

Placebo Comparator group

Description:

Vehicle Gel twice daily to the face for 2 weeks

Treatment:

Drug: Vehicle Gel