Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 72 of 233 for:    acne AND Percent

P2 Multi-center Study of SB204 Gel in the Treatment of Acne Vulgaris

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02242760
Recruitment Status : Completed
First Posted : September 17, 2014
Last Update Posted : January 11, 2019
Sponsor:
Information provided by (Responsible Party):
Novan, Inc.

Brief Summary:
This is a randomized, multi-center, double-blinded study in subjects with moderate to severe acne vulgaris. Subjects eligible to enroll will be treated once or twice daily with 2 concentrations of a topical drug in development or a vehicle. Subjects will be treated for up to 12 weeks.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: SB204 2% Drug: SB204 4% Drug: Vehicle Gel Phase 2

Detailed Description:
A randomized, multi-center, double-blinded study in subjects with moderate to severe acne vulgaris. Subjects eligible to enroll will be treated once or twice daily with 2 concentrations of a topical drug in development or a vehicle. Subjects will be treated for up to 12 weeks.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 213 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Multi-Center, Randomized, Evaluator-Blinded, Vehicle-Controlled Study Comparing the Efficacy, Tolerability, and Safety of SB204 Gel and Vehicle Gel Once or Twice Daily in the Treatment of Acne Vulgaris
Study Start Date : November 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Experimental: SB204 2% Twice daily
Twice daily SB204 2%
Drug: SB204 2%
Applied topically twice daily
Other Name: NVN1000

Experimental: SB204 4% daily
Once daily SB204 4%
Drug: SB204 4%
Applied topically daily
Other Name: NVN1000

Placebo Comparator: Vehicle Gel Daily
Vehicle Gel Daily
Drug: Vehicle Gel
Applied topically twice and once daily
Other Name: Placeco

Placebo Comparator: Vehicle Gel Twice Daily
Twice daily Vehicle Gel
Drug: Vehicle Gel
Applied topically twice and once daily
Other Name: Placeco

Experimental: SB204 4% Twice Daily
Twice daily SB204 4%
Drug: SB204 4%
Applied topically daily
Other Name: NVN1000




Primary Outcome Measures :
  1. Absolute change in inflammatory lesion counts [ Time Frame: 12 weeks ]
    Change in inflammatory lesion count from Baseline to Week 12

  2. Absolute change in non-inflammatory lesion counts [ Time Frame: 12 weeks ]
    Absolute Change in non-inflammatory lesion count from Baseline to Week 12

  3. Proportion of success according to the dichotomized Investigator Global Assessment [IGA] at end of treatment [ Time Frame: 12 weeks ]
    Proportion of subjects at end of treatment achieving IGA of 'clear' or 'almost clear' and a change of at least 2 in the IGA from baseline


Secondary Outcome Measures :
  1. Percent change in inflammatory lesion count from Baseline to Week 12 [ Time Frame: 12 weeks ]
    The percent change in inflammatory lesion count from Baseline to Week 12

  2. Percent change in non-inflammatory lesion count from Baseline to Week 12 [ Time Frame: 12 weeks ]
    The percent change in non-inflammatory lesion count from Baseline to Week 12

  3. Median time to improvement [ Time Frame: Baseline through Week 12 ]
    Decrease in lesion count from Baseline to Week 12



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Moderate to severe acne
  • 25-70 non-inflammatory lesions at Baseline
  • 20-40 inflammatory lesions at Baseline

Exclusion Criteria:

  • Subjects with known allergy to any component of the test material or vehicle
  • Women who are pregnant or nursing

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): NCT02242760


Locations
Layout table for location information
United States, Arkansas
Qst acne site #1
Hot Springs, Arkansas, United States, 71913
United States, California
QST Site #118
Encinitas, California, United States, 92024
QST Site #111
San Diego, California, United States, 92123
QST Site #113
San Diego, California, United States, 92123
QST Site #119
Santa Monica, California, United States, 90404
United States, Florida
QST Site #103
Boca Raton, Florida, United States, 33486
QST Site # 110
Pinellas Park, Florida, United States, 33781
United States, Georgia
QST Site # 116
Newnan, Georgia, United States, 302636
United States, Kentucky
QST Site #117
Louisville, Kentucky, United States, 40202
United States, Michigan
QST Site #112
Detroit, Michigan, United States, 48202
QST Site #120
Warren, Michigan, United States, 48088
United States, Minnesota
QST Site # 121
Minneapolis, Minnesota, United States, 55432
United States, New York
QST Site #107
New York, New York, United States, 10155
QST Site #108
Rochester, New York, United States, 14623
QST Site #109
Rochester, New York, United States, 14625
QST Site #104
Stony Brook, New York, United States, 11790
United States, Texas
QST Site # 102
San Antonio, Texas, United States, 78229
United States, Utah
QST Site #106
Salt Lake City, Utah, United States, 84117
United States, Virginia
QST #105
Lynchburg, Virginia, United States, 24501
QST Site #114
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
Novan, Inc.
Investigators
Layout table for investigator information
Study Director: M J Rico, MD Novan, Inc.

Layout table for additonal information
Responsible Party: Novan, Inc.
ClinicalTrials.gov Identifier: NCT02242760     History of Changes
Other Study ID Numbers: NI-AC202
First Posted: September 17, 2014    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: November 2018

Keywords provided by Novan, Inc.:
acne

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