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Trial record 29 of 166 for:    acne AND Vehicle

A Study to Evaluate the Efficacy and Safety of Topical Administration of FMX101 in the Treatment of Moderate-to-Severe 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: NCT03271021
Recruitment Status : Completed
First Posted : September 1, 2017
Results First Posted : February 10, 2020
Last Update Posted : February 21, 2020
Sponsor:
Information provided by (Responsible Party):
Foamix Ltd.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Acne Vulgaris
Interventions Drug: FMX101
Drug: Vehicle Foam
Enrollment 1488
Recruitment Details  
Pre-assignment Details  
Arm/Group Title FMX101, 4% Minocycline Foam Vehicle Foam
Hide Arm/Group Description

FMX101, 4% minocycline foam applied topically once daily for 12 weeks

FMX101: FMX101, 4% minocycline foam

Vehicle foam applied topically once daily for 12 weeks

Vehicle Foam: Vehicle Foam

Period Title: Overall Study
Started 738 750
Completed 649 644
Not Completed 89 106
Reason Not Completed
Adverse Event             3             2
Withdrawal by Subject             36             53
Lost to Follow-up             34             39
Protocol Violation             6             4
Abnormal Lab Results             1             0
Miscellaneous             9             8
Arm/Group Title FMX101, 4% Minocycline Foam Vehicle Foam Total
Hide Arm/Group Description

FMX101, 4% minocycline foam applied topically once daily for 12 weeks

FMX101: FMX101, 4% minocycline foam

Vehicle foam applied topically once daily for 12 weeks

Vehicle Foam: Vehicle Foam

Total of all reporting groups
Overall Number of Baseline Participants 738 750 1488
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 738 participants 750 participants 1488 participants
9-12
42
   5.7%
41
   5.5%
83
   5.6%
13-17
321
  43.5%
309
  41.2%
630
  42.3%
≥ 18
375
  50.8%
400
  53.3%
775
  52.1%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 738 participants 750 participants 1488 participants
Female
460
  62.3%
469
  62.5%
929
  62.4%
Male
278
  37.7%
281
  37.5%
559
  37.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 738 participants 750 participants 1488 participants
Hispanic or Latino
266
  36.0%
252
  33.6%
518
  34.8%
Not Hispanic or Latino
472
  64.0%
498
  66.4%
970
  65.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 738 participants 750 participants 1488 participants
American Indian or Alaska Native
1
   0.1%
3
   0.4%
4
   0.3%
Asian
25
   3.4%
29
   3.9%
54
   3.6%
Native Hawaiian or Other Pacific Islander
2
   0.3%
4
   0.5%
6
   0.4%
Black or African American
125
  16.9%
144
  19.2%
269
  18.1%
White
571
  77.4%
560
  74.7%
1131
  76.0%
More than one race
14
   1.9%
10
   1.3%
24
   1.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 12.
Hide Description A decrease in the inflammatory lesion count from Baseline to Week 12.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FMX101, 4% Minocycline Foam Vehicle Foam
Hide Arm/Group Description:

FMX101, 4% minocycline foam applied topically once daily for 12 weeks

FMX101: FMX101, 4% minocycline foam

Vehicle foam applied topically once daily for 12 weeks

Vehicle Foam: Vehicle Foam

Overall Number of Participants Analyzed 738 750
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Lesion Count
16.39
(15.53 to 17.25)
12.74
(11.88 to 13.61)
2.Primary Outcome
Title Investigator Global Assessment (IGA) Treatment Success (Dichotomized as Yes/no) at Week 12, Where Success is Defined as an IGA Score of 0 or 1, and at Least a 2-grade Improvement (Decrease) From Baseline
Hide Description [Not Specified]
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FMX101, 4% Minocycline Foam Vehicle Foam
Hide Arm/Group Description:

FMX101, 4% minocycline foam applied topically once daily for 12 weeks

FMX101: FMX101, 4% minocycline foam

Vehicle foam applied topically once daily for 12 weeks

Vehicle Foam: Vehicle Foam

Overall Number of Participants Analyzed 738 750
Measure Type: Number
Unit of Measure: participants
199 133
Time Frame Up to 16 weeks
Adverse Event Reporting Description Number of participants represents the Safety Population.
 
Arm/Group Title FMX101, 4% Minocycline Foam Vehicle Foam
Hide Arm/Group Description

FMX101, 4% minocycline foam applied topically once daily for 12 weeks

FMX101: FMX101, 4% minocycline foam

Vehicle foam applied topically once daily for 12 weeks

Vehicle Foam: Vehicle Foam

All-Cause Mortality
FMX101, 4% Minocycline Foam Vehicle Foam
Affected / at Risk (%) Affected / at Risk (%)
Total   0/737 (0.00%)      0/747 (0.00%)    
Hide Serious Adverse Events
FMX101, 4% Minocycline Foam Vehicle Foam
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/737 (0.14%)      4/747 (0.54%)    
Gastrointestinal disorders     
Chron's disease *  0/737 (0.00%)  0 3/747 (0.40%)  3
Hepatobiliary disorders     
Cholecystitis *  0/737 (0.00%)  0 1/747 (0.13%)  1
Pregnancy, puerperium and perinatal conditions     
Pregnancy *  1/737 (0.14%)  1 1/747 (0.13%)  1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
FMX101, 4% Minocycline Foam Vehicle Foam
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/737 (0.00%)      0/747 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Director, Clinical Operations
Organization: Foamix Pharmaceuticals
Phone: 9089630117
EMail: kendra.gulbronson@foamix.com
Layout table for additonal information
Responsible Party: Foamix Ltd.
ClinicalTrials.gov Identifier: NCT03271021    
Other Study ID Numbers: FX2017-22
First Submitted: August 30, 2017
First Posted: September 1, 2017
Results First Submitted: January 16, 2020
Results First Posted: February 10, 2020
Last Update Posted: February 21, 2020