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A Phase 1 Study Evaluating Safety and Tolerability of NVN1000 Gel

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ClinicalTrials.gov Identifier: NCT01844739
Recruitment Status : Completed
First Posted : May 1, 2013
Last Update Posted : November 19, 2018
Sponsor:
Information provided by (Responsible Party):
Novan, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: NVN1000 4% Gel Drug: Vehicle Gel Phase 1

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : April 2013
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Experimental: NVN1000 4% Gel
NVN1000 4% Gel twice daily to the face for 2 weeks
Drug: NVN1000 4% Gel
Applied topically twice daily
Other Name: SB204

Placebo Comparator: Vehicle Gel
Vehicle Gel twice daily to the face for 2 weeks
Drug: Vehicle Gel
Applied topically twice daily
Other Name: Placebo




Primary Outcome Measures :
  1. Tolerability based on the cutaneous tolerability scores [ Time Frame: 2 weeks ]
    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.


Secondary Outcome Measures :
  1. Safety which includes reported adverse events, clinically significant changes in physical exam, and labs [ Time Frame: 2 weeks ]
    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.


Other Outcome Measures:
  1. Change in P. acnes counts [ Time Frame: 2 weeks ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01844739


Locations
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United States, Pennsylvania
KGL
Broomall, Pennsylvania, United States, 19008
Sponsors and Collaborators
Novan, Inc.
Investigators
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Study Director: Joyce Rico, MD Novan, Inc.

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Responsible Party: Novan, Inc.
ClinicalTrials.gov Identifier: NCT01844739     History of Changes
Other Study ID Numbers: NI-AC006
First Posted: May 1, 2013    Key Record Dates
Last Update Posted: November 19, 2018
Last Verified: November 2018
Keywords provided by Novan, Inc.:
Propionibacterium acnes
acne
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases