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A Phase 1 Study Assessing Local Cutaneous Effects of SB204

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ClinicalTrials.gov Identifier: NCT02250430
Recruitment Status : Completed
First Posted : September 26, 2014
Last Update Posted : November 19, 2018
Sponsor:
Information provided by (Responsible Party):
Novan, Inc.

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.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: SB204 Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : September 2014
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Experimental: Topical SB204
Topical application of SB204 2% and 4% twice daily for 2 days and once on Day 3
Drug: SB204
Applied topically twice a day on days 1, 2 and 3 to left and right cheeks
Other Name: NVN1000




Primary Outcome Measures :
  1. Intensity of erythema following application of SB204 2% and SB204 4%. [ Time Frame: 3 days ]
  2. Duration of erythema following application of SB204 2% and SB204 4%. [ Time Frame: 3 days ]

Secondary Outcome Measures :
  1. pH on the surface of the skin after topical application of 2 concentrations of SB204 [ Time Frame: 3 days ]


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteers

Exclusion Criteria:

  • Women who are pregnant or nursing
  • Subject with known sensitivity to a component of the test materials

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): NCT02250430


Locations
United States, Pennsylvania
KGL
Broomall, Pennsylvania, United States, 19008
Sponsors and Collaborators
Novan, Inc.
Investigators
Principal Investigator: Stuart Lessin, MD KGL, Inc.

Responsible Party: Novan, Inc.
ClinicalTrials.gov Identifier: NCT02250430     History of Changes
Other Study ID Numbers: NI-AC102
First Posted: September 26, 2014    Key Record Dates
Last Update Posted: November 19, 2018
Last Verified: November 2018

Keywords provided by Novan, Inc.:
acne

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases