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Completed

NCT Number: NCT02250430

A Phase 1 Study Assessing Local Cutaneous Effects of SB204

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.

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Key information

Conditions

Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

KGL

Broomall, Pennsylvania, 19008, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy volunteers

Exclusion criteria

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

Treatment and study plan

SB204

Drug

Applied topically twice a day on days 1, 2 and 3 to left and right cheeks

Other names: NVN1000

Primary outcomes

  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 outcomes

  1. pH on the surface of the skin after topical application of 2 concentrations of SB204

    Time frame: 3 days

Sponsors and collaborators

Lead sponsor

Novan, Inc.

Industry

Registry information

Official study title

A Phase 1, Single-Center, Split-Face Study Assessing Local Cutaneous Effects After Application of SB204 2% and SB204 4% in Healthy Volunteers

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Sep 26, 2014
Registry last updated
Nov 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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