Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy and Safety Study Comparing CD07805/47 Gel 0.5% to Azelaic Acid Gel 15% in Subjects With Erythema of Rosacea

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: NCT01659853
Recruitment Status : Completed
First Posted : August 8, 2012
Results First Posted : July 10, 2014
Last Update Posted : July 10, 2014
Sponsor:
Information provided by (Responsible Party):
Galderma Laboratories, L.P.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Erythema
Rosacea
Interventions Drug: CD07805/47 gel 0.5%/CD07805/47 Vehicle
Drug: azelaic acid gel 15%
Enrollment 70
Recruitment Details  
Pre-assignment Details  
Arm/Group Title CD07805/47 Gel 0.5% and Vehicle, Then Azelaic Acid Gel 15% Azelaic Acid Gel 15%, Then CD07805/47 Gel 0.5% and Vehicle
Hide Arm/Group Description

Subjects were randomly assigned to treatment sequence.

Subjects who received CD07805/47 gel 0.5% and CD07805/47 gel vehicle during Period 1 (baseline to Day 15) will switch to azelaic acid gel in Period 2.

Subjects who received azelaic acid gel 15% during Period 1 (baseline to Day 15) switched to CD07805/47 gel 0.5% and CD07805/47 gel vehicle in period 2.

Subjects assigned to brimonidine tartrate gel 0.5% applied it once daily in the morning and applied brimonidine tartrate gel vehicle once daily in the evening. Subjects assigned to azelaic acid gel 15% applied it twice daily according to FDA approved prescribing information.

Subjects were randomly assigned to treatment sequence.

Subjects who received CD07805/47 gel 0.5% and CD07805/47 gel vehicle during Period 1 (baseline to Day 15) will switch to azelaic acid gel in Period 2.

Subjects who received azelaic acid gel 15% during Period 1 (baseline to Day 15) switched to CD07805/47 gel 0.5% and CD07805/47 gel vehicle in period 2.

Subjects assigned to brimonidine tartrate gel 0.5% applied it once daily in the morning and applied brimonidine tartrate gel vehicle once daily in the evening. Subjects assigned to azelaic acid gel 15% applied it twice daily according to FDA approved prescribing information.

Period Title: Treatment Period 1
Started 35 35
Completed 35 35
Not Completed 0 0
Period Title: Washout , 3 to 7 Days
Started 35 35
Completed 33 35
Not Completed 2 0
Reason Not Completed
Adverse Event             1             0
Protocol Violation             1             0
Period Title: Treatment Period 2
Started 33 35
Completed 33 35
Not Completed 0 0
Arm/Group Title Overall Study
Hide Arm/Group Description

Participants were randomly assigned to treatment sequence.

Subjects who received CD07805/47 gel 0.5% and CD07805/47 gel vehicle during Period 1 (baseline to Day 15) switched to azelaic acid gel in Period 2.

Subjects who received azelaic acid gel 15% during Period 1 (baseline to Day 15) switched to CD07805/47 gel 0.5% and CD07805/47 gel vehicle in Period 2.

Subjects assigned to brimonidine tartrate gel 0.5% applied it once daily in the morning and applied brimonidine tartrate gel vehicle once daily in the evening. Subjects assigned to azelaic acid gel 15% applied it twice daily according to FDA approved prescribing information.

Overall Number of Baseline Participants 70
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants
<=18 years
0
   0.0%
Between 18 and 65 years
62
  88.6%
>=65 years
8
  11.4%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 70 participants
52.4  (10.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants
Female
52
  74.3%
Male
18
  25.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants
American Indian or Alaska Native
1
   1.4%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
69
  98.6%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 70 participants
70
Fitzpatrick skin type   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 70 participants
I 6
II 35
III 24
IV 4
V 1
VI 0
[1]
Measure Description: Fitzpatrick Skin Type Classification Scale I, always burns easily; never tans II, always burns easily; tans minimally and with difficulty III, burns minimally; tans gradually and uniformly (light brown) IV, burns minimally; always tans well (moderate brown) V, rarely burns; tans very easily (dark brown) VI, never burns, tans very easily (black)
Skin type  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 70 participants
Dry 14
Normal 33
Oily 6
Combination 17
1.Primary Outcome
Title Composite Success
Hide Description Composite Success, defined as a 2-grade improvement at 6 hours on both the clinician's and subject's erythema assessments at the end of each treatment period
Time Frame Hour 6 on Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
A carryover effect was observed from Period 1 to Period 2. Therefore, as specified in the protocol, only the Period 1 results were analyzed.
Arm/Group Title CD07805/47 Gel 0.5% and Vehicle Azelaic Acid Gel 15%
Hide Arm/Group Description:

Participants were randomly assigned to treatment sequence. Thirty-five subjects received CD07805/47 gel 0.5% and 35 received azelaic acid gel in Period 1.

A carryover effect was observed from Period 1 to Period 2. Therefore, as specified in the protocol, only the Period 1 results were analyzed.

Participants were randomly assigned to treatment sequence. Thirty-five subjects received CD07805/47 gel 0.5% and 35 received azelaic acid gel in Period 1.

A carryover effect was observed from Period 1 to Period 2. Therefore, as specified in the protocol, only the Period 1 results were analyzed.

Overall Number of Participants Analyzed 35 35
Measure Type: Number
Unit of Measure: percentage of subjects
14.3 5.7
2.Secondary Outcome
Title Onset of Action
Hide Description Onset of action, defined as an improvement on both the clinician's and subject's erythema assessments at 30 minutes post baseline application
Time Frame 30 minutes after baseline treatment application on Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
A carryover effect was observed from Period 1 to Period 2. Therefore, as specified in the protocol, only the Period 1 results were analyzed. All 70 enrolled subjects were analyzed for efficacy.
Arm/Group Title CD07805/47 Gel 0.5 and Vehicle Azelaic Acid 15%
Hide Arm/Group Description:

Participants were randomly assigned to treatment sequence. Thirty-five subjects received CD07805/47 gel 0.5% and 35 received azelaic acid gel in Period 1.

A carryover effect was observed from Period 1 to Period 2. Therefore, as specified in the protocol, only the Period 1 results were analyzed.

Participants were randomly assigned to treatment sequence. Thirty-five subjects received CD07805/47 gel 0.5% and 35 received azelaic acid gel in Period 1.

A carryover effect was observed from Period 1 to Period 2. Therefore, as specified in the protocol, only the Period 1 results were analyzed.

Overall Number of Participants Analyzed 35 35
Measure Type: Number
Unit of Measure: percentage of subjects
31.4 29.4
Time Frame 15 days
Adverse Event Reporting Description Two subjects in the CD07805/47 group in period 1 did not enter period 2 (1 AE and 1 protocol violation). Therefore, 70 subjects received CD07805/47 and 68 received azelaic acid.
 
Arm/Group Title CD07805/47 Gel 0.5 and Vehicle Azelaic Acid 15%
Hide Arm/Group Description

Participants were randomly assigned to treatment sequence.

Subjects who received CD07805/47 gel 0.5% and CD07805/47 gel vehicle during Period 1 (baseline to Day 15) switched to azelaic acid gel in Period 2.

Subjects who received azelaic acid gel 15% during Period 1 (baseline to Day 15) switched to CD07805/47 gel 0.5% and CD07805/47 gel vehicle in Period 2.

Subjects assigned to brimonidine tartrate gel 0.5% applied it once daily in the morning and applied brimonidine tartrate gel vehicle once daily in the evening. Subjects assigned to azelaic acid gel 15% applied it twice daily according to FDA approved prescribing information.

Participants were randomly assigned to treatment sequence.

Subjects who received CD07805/47 gel 0.5% and CD07805/47 gel vehicle during Period 1 (baseline to Day 15) switched to azelaic acid gel in Period 2.

Subjects who received azelaic acid gel 15% during Period 1 (baseline to Day 15) switched to CD07805/47 gel 0.5% and CD07805/47 gel vehicle in Period 2.

Subjects assigned to brimonidine tartrate gel 0.5% applied it once daily in the morning and applied brimonidine tartrate gel vehicle once daily in the evening. Subjects assigned to azelaic acid gel 15% applied it twice daily according to FDA approved prescribing information.

All-Cause Mortality
CD07805/47 Gel 0.5 and Vehicle Azelaic Acid 15%
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
CD07805/47 Gel 0.5 and Vehicle Azelaic Acid 15%
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/70 (0.00%)      0/68 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
CD07805/47 Gel 0.5 and Vehicle Azelaic Acid 15%
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   19/70 (27.14%)      27/68 (39.71%)    
General disorders     
Medication residue  1  0/70 (0.00%)  0 9/68 (13.24%)  9
Infections and infestations     
Upper respiratory infection  1  2/70 (2.86%)  2 2/68 (2.94%)  2
Skin and subcutaneous tissue disorders     
Erythema  1  15/70 (21.43%)  20 2/68 (2.94%)  2
Pain of skin  1  0/70 (0.00%)  0 6/68 (8.82%)  6
Pruritus  1  1/70 (1.43%)  1 10/68 (14.71%)  11
Skin burning sensation  1  1/70 (1.43%)  1 6/68 (8.82%)  6
Skin discomfort  1  0/70 (0.00%)  0 2/68 (2.94%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.0
A significant period effect was observed for CEA indicating there was carryover from period 1 to period 2. Therefore, as stated a priori in the protocol, only data from period 1 were used to analyze efficacy. All safety data are reported.
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: Dr. Warren Winkelman
Organization: Galerma Laboratories
Phone: 817-961-5494
EMail: warren.winkelman@galderma.com
Layout table for additonal information
Responsible Party: Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier: NCT01659853    
Other Study ID Numbers: US10219
First Submitted: August 6, 2012
First Posted: August 8, 2012
Results First Submitted: January 15, 2014
Results First Posted: July 10, 2014
Last Update Posted: July 10, 2014