Clinical Trials Logo
  1. Home
  2. Acne Vulgaris
  3. NCT02581072
  4. Details
NCT02581072 Clinical Trial

A Thorough ECG Study in Subjects With Acne Vulgaris Treated With SB204

Acne Vulgaris Clinical Trial

Official title:
A Double-blind, Double-dummy, Randomized, 4-period Crossover Study to Define the ECG Effects of SB204 Using a Clinical and Supratherapeutic Dose Compared With Placebo and Moxifloxacin in Subjects With Acne Vulgaris: A Thorough ECG STudy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02581072
Other study ID # NI-AC104
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date October 2015
Est. completion date April 2016

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

Clinical Trial Summary

A Double-Blind, Double-Dummy, Randomized, 4-Period Crossover Study to Define the ECG Effects of SB204 Using a Clinical and Supratherapeutic Dose Compared with Placebo and Moxifloxacin (a Positive Control) in Subjects with Acne Vulgaris: A Thorough ECG Study

Description:

A Double-Blind, Double-Dummy, Randomized, 4-Period, Crossover Study to Define the ECG Effects of SB204 Using a Clinical and a Supratherapeutic Dose Compared with Placebo and Moxifloxacin (a Positive Control) in Subjects with Acne Vulgaris: A Thorough ECG Study

Recruitment information / eligibility
Status Completed
Enrollment 56
Est. completion date April 2016
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Moderate to severe acne

- 20 inflammatory and 25 non-inflammatory acne lesions

Exclusion Criteria:

- Pregnant, trying to become pregnant, or nursing

- Known allergy to any component of the topical SB204 formulation

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• SB204 4%
Applied topically once
• SB204 8% or 12%
Applied once topically
• Vehicle
Applied topically once

Locations
Country Name City State
United States Spaulding Clinical Research, LLC West Bend Wisconsin

Sponsors (2)
Lead Sponsor Collaborator
Novan, Inc. Spaulding Clinical Research LLC

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Define ECG effect of SB204 at therapeutic and supratherapeutic dose concentrations as measured by the difference between time-matched baseline adjusted QTcF interval for the groups recieving SB204 and placebo. 15 days
Secondary Categorical analysis of the QTc interval to determine number and percentage of time points and subjects by dose group with absolute QT/QTc > 450, 480, and 500 ms. 15 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 NCT02525822 - Study to Compare the Safety and Efficacy of IDP-123 Lotion to Tazorac Cream in the Treatment of Acne Vulgaris Phase 2
Completed NCT02709902 - Study Comparing Adapalene/BP Gel to EPIDUO® FORTE and Both to a Placebo Control in Treatment of Acne Vulgaris Phase 1
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 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 NCT02913001 - The Effect of a Low Glycemic Load Diet on Hormonal Markers Associated With Acne N/A
Completed NCT02250430 - A Phase 1 Study Assessing Local Cutaneous Effects of SB204 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 NCT01694810 - Cutaneous Tolerability and Safety of NVN1000 Topical Gel in Healthy Volunteers 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 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