Back to resultsA Phase 1 Study Assessing Local Cutaneous Effects of SB204
Primary Purpose
Acne Vulgaris
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SB204
Sponsored by
About this trial
This is an interventional treatment trial for Acne Vulgaris focused on measuring acne
Eligibility Criteria
Inclusion Criteria:
- Healthy volunteers
Exclusion Criteria:
- Women who are pregnant or nursing
- Subject with known sensitivity to a component of the test materials
Sites / Locations
- KGL
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Topical SB204
Arm Description
Topical application of SB204 2% and 4% twice daily for 2 days and once on Day 3
Outcomes
Primary Outcome Measures
Intensity of erythema following application of SB204 2% and SB204 4%.
Duration of erythema following application of SB204 2% and SB204 4%.
Secondary Outcome Measures
pH on the surface of the skin after topical application of 2 concentrations of SB204
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02250430
Brief Title
A Phase 1 Study Assessing Local Cutaneous Effects of SB204
Official Title
A Phase 1, Single-Center, Split-Face Study Assessing Local Cutaneous Effects After Application of SB204 2% and SB204 4% in Healthy Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novan, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
In this study, color (erythema) and pH will be measured on 3 consecutive days after application of 2 doses of SB204 to the cheeks of healthy volunteers.
Detailed Description
This study is to evaluate local cutaneous effects, including intensity and duration of erythema and changes in pH following 5 applications (twice daily for two days and once daily on the third day) of SB204 2% and SB204 4% twice daily to the face for 3 days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
Keywords
acne
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Topical SB204
Arm Type
Experimental
Arm Description
Topical application of SB204 2% and 4% twice daily for 2 days and once on Day 3
Intervention Type
Drug
Intervention Name(s)
SB204
Other Intervention Name(s)
NVN1000
Intervention Description
Applied topically twice a day on days 1, 2 and 3 to left and right cheeks
Primary Outcome Measure Information:
Title
Intensity of erythema following application of SB204 2% and SB204 4%.
Time Frame
3 days
Title
Duration of erythema following application of SB204 2% and SB204 4%.
Time Frame
3 days
Secondary Outcome Measure Information:
Title
pH on the surface of the skin after topical application of 2 concentrations of SB204
Time Frame
3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy volunteers
Exclusion Criteria:
Women who are pregnant or nursing
Subject with known sensitivity to a component of the test materials
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stuart Lessin, MD
Organizational Affiliation
KGL, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
KGL
City
Broomall
State/Province
Pennsylvania
ZIP/Postal Code
19008
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Phase 1 Study Assessing Local Cutaneous Effects of SB204
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