A Phase 1 Study Evaluating Safety and Tolerability of NVN1000 Gel

Acne Vulgaris Clinical Trial

Official title:

A Phase 1, Multiple-dose, Evaluator-blind, Randomized, Parallel Group Study Evaluating the Safety and Cutaneous Tolerability of SB204 (NVN1000 Gel) in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01844739
• Other study ID #: NI-AC006
• Status: Completed
• Phase: Phase 1
• Start date: April 2013
• Est. completion date: June 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• NVN1000 4% Gel
Applied topically twice daily
• Vehicle Gel
Applied topically twice daily

Locations

Country	Name	City	State
United States	KGL	Broomall	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Novan, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in P. acnes counts	P. acnes counts will be obtained by culture at Baseline, Week 1 and Week 2/end of treatment. The change in P. acnes counts over time will be analyzed.	2 weeks
Primary	Tolerability based on the cutaneous tolerability scores	Cutaneous tolerability assessments (erythema, scaling, dryness, pruritus, burning/stinging) will be summarized with frequency counts and percentages at each score category for Week 1 and Week 2.	2 weeks
Secondary	Safety which includes reported adverse events, clinically significant changes in physical exam, and labs	Adverse events will be summarized by treatment group. Clinically significant changes in physical examination, including vital signs, over the treatment period will be reported as adverse events. Changes in laboratory results will be analyzed.	2 weeks