Clinical Trials Logo
  1. Home
  2. Acne Vulgaris
  3. NCT02250430
  4. Details
NCT02250430 Clinical Trial

A Phase 1 Study Assessing Local Cutaneous Effects of SB204

Acne Vulgaris Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02250430
Other study ID # NI-AC102
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date September 2014
Est. completion date September 2014

Study information
Verified date November 2018
Source Novan, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 8
Est. completion date September 2014
Est. primary completion date September 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria:

- Healthy volunteers

Exclusion Criteria:

- Women who are pregnant or nursing

- Subject with known sensitivity to a component of the test materials

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• SB204
Applied topically twice a day on days 1, 2 and 3 to left and right cheeks

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
Primary Intensity of erythema following application of SB204 2% and SB204 4%. 3 days
Primary Duration of erythema following application of SB204 2% and SB204 4%. 3 days
Secondary pH on the surface of the skin after topical application of 2 concentrations of SB204 3 days
See also
  Status Clinical Trial Phase
Completed NCT04321070 - Bio-equivalence Study With Clinical Endpoints in the Treatment of Acne Vulgaris Phase 1
Recruiting NCT05755256 - The Impact of Probiotics on Skin Hydration in Youth With Mild Acne Phase 2
Completed NCT05131373 - Safety, Tolerability, and Immunogenicity of ORI-A-ce001 for the Treatment of Acne Vulgaris Phase 1
Completed NCT01445301 - Study STF115287, a Clinical Confirmation Study of GSK2585823 in the Treatment of Acne Vulgaris in Japanese Subjects Phase 3
Completed NCT03303170 - Non-Significant Risk Study of Sebacia Microparticles in the Treatment of Facial Acne Vulgaris N/A
Completed NCT04698239 - Clinical Evaluation of the Safety and Benefits of the Milesman 445 nm Blue Laser on Inflammatory Acne Lesions. N/A
Completed NCT02886715 - A Study Comparing Tazarotene Cream 0.1% to TAZORAC® (Tazarotene) Cream 0.1% and Both to a Placebo Control in the Treatment of Acne Vulgaris Phase 3
Terminated NCT02924428 - Venus Versa Diamondpolar Applicator Treatment Followed by AC Dual Applicator Treatment for Facial Acne Vulgaris N/A
Not yet recruiting NCT02535871 - A Study Comparing the Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris Phase 3
Not yet recruiting NCT02525822 - Study to Compare the Safety and Efficacy of IDP-123 Lotion to Tazorac Cream in the Treatment of Acne Vulgaris Phase 2
Not yet recruiting NCT02491060 - A Study Comparing the Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris Phase 3
Completed NCT02709902 - Study Comparing Adapalene/BP Gel to EPIDUO® FORTE and Both to a Placebo Control in Treatment of Acne Vulgaris Phase 1
Completed NCT02913001 - The Effect of a Low Glycemic Load Diet on Hormonal Markers Associated With Acne N/A
Completed NCT01694810 - Cutaneous Tolerability and Safety of NVN1000 Topical Gel in Healthy Volunteers Phase 1
Completed NCT01769664 - A Study Comparing Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel to Duac® Topical Gel in the Treatment of Acne Vulgaris Phase 1
Completed NCT01727440 - Identifying the Genetic Predictors of Severe Acne Vulgaris and the Outcome of Oral Isotretinoin Treatment N/A
Completed NCT01194375 - A Dose-Ranging Study Evaluating the Safety and Efficacy of IDP-107 in Patients With Acne Vulgaris Phase 2
Completed NCT02524665 - 8 Week Study to Evaluate and Compare the Efficacy and Tolerability of MAXCLARITY II and MURAD To Treat Acne Phase 4
Completed NCT01706250 - U0289-401: Eight Week, Split-face, Study to Determine and Compare the Efficacy and Tolerability of MAXCLARITY™ II to PROACTIV™ Phase 4
Completed NCT00991198 - The Role of Topically Dissolved Oxygen (TDO) to Ameliorate Signs of Photodamage Phase 2