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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01844739
Other study ID # NI-AC006
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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