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Safety and Efficacy of Tazarotene Cream 0.1% Compared With Adapalene Gel 0.3% in the Treatment of Moderate to Severe Facial Acne Vulgaris

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ClinicalTrials.gov Identifier: NCT00829049
Recruitment Status : Terminated (Study enrollment was terminated due to company decision before the target enrollment of 220 patients was reached.)
First Posted : January 26, 2009
Results First Posted : September 12, 2012
Last Update Posted : September 12, 2012
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition Acne Vulgaris
Interventions Drug: Tazarotene Cream 0.1%
Drug: Adapalene
Enrollment 165
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tazarotene Cream 0.1% Adapalene Gel 0.3%
Hide Arm/Group Description 1 pea-size amount, QD x 16 weeks 1 pea-size amount, QD x 16 weeks
Period Title: Overall Study
Started 77 88
Completed 60 68
Not Completed 17 20
Arm/Group Title Tazarotene Cream 0.1% Adapalene Gel 0.3% Total
Hide Arm/Group Description 1 pea-size amount, QD x 16 weeks 1 pea-size amount, QD x 16 weeks Total of all reporting groups
Overall Number of Baseline Participants 77 88 165
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 77 participants 88 participants 165 participants
20.9
(12.6 to 45.7)
20.8
(12.6 to 51.4)
20.9
(12.6 to 51.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 77 participants 88 participants 165 participants
Female
48
  62.3%
56
  63.6%
104
  63.0%
Male
29
  37.7%
32
  36.4%
61
  37.0%
1.Primary Outcome
Title Median Percent Change From Baseline in the Non-Inflammatory Lesion Counts (Open and Closed Comedones) at Week 12
Hide Description Median percent change from baseline in the non-inflammatory lesion counts (open and closed comedones) at Week 12. Comedones are small bumps on the skin (lesions) caused by acne and found at the opening of a skin pore. Open comedones (also known as blackheads) have a microscopic opening to the skin surface, while closed comedones (also known as whiteheads or pimples) lack the opening to the skin. A negative number change from baseline indicates a reduction in lesion counts(improvement).
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat population included all randomized patients. The number of patients that were analyzed reflects the actual number of patients for which data were available for this outcome measure.
Arm/Group Title Tazarotene Cream 0.1% Adapalene Gel 0.3%
Hide Arm/Group Description:
1 pea-size amount, QD x 16 weeks
1 pea-size amount, QD x 16 weeks
Overall Number of Participants Analyzed 62 73
Median (Full Range)
Unit of Measure: Percent Change
-68.14
(-96.23 to -2.99)
-60.00
(-100.00 to 42.86)
2.Secondary Outcome
Title Percentage of Patients With >= 1 Grade Improvement in the Investigator Global Assessment at Week 16
Hide Description Percentage of patients with >= 1 grade improvement (decrease in score) in the Investigator Global Assessment (IGA) at Week 16. The IGA is a 5-point scale used by the investigator to assess overall acne severity, where 0 equals clear skin (no evidence of acne) and 4 equals severe acne.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat population included all randomized patients. The number of patients that were analyzed reflects the actual number of patients for which data were available for this outcome measure.
Arm/Group Title Tazarotene Cream 0.1% Adapalene Gel 0.3%
Hide Arm/Group Description:
1 pea-size amount, QD x 16 weeks
1 pea-size amount, QD x 16 weeks
Overall Number of Participants Analyzed 61 72
Measure Type: Number
Unit of Measure: Percentage of patients
77.0 66.7
3.Secondary Outcome
Title Percentage of Patients With >= 2 Grade Improvement in the Overall Disease Severity Score at Week 12
Hide Description Percentage of patients with >= 2 grade improvement (decrease in score) in the overall disease severity score at Week 12. The overall disease severity score was evaluated by the investigator using a 7-point scale to rate the overall acne severity (lesions, inflammation, facial redness, and skin condition), where 0=no acne lesions and 6=most severe acne.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat population included all randomized patients. The number of patients that were analyzed reflects the actual number of patients for which data were available for this outcome measure.
Arm/Group Title Tazarotene Cream 0.1% Adapalene Gel 0.3%
Hide Arm/Group Description:
1 pea-size amount, QD x 16 weeks
1 pea-size amount, QD x 16 weeks
Overall Number of Participants Analyzed 61 73
Measure Type: Number
Unit of Measure: Percentage of patients
50.8 32.9
4.Secondary Outcome
Title Median Percent Change From Baseline in Inflammatory Lesion Counts (Papules/Pustules, Nodules) at Week 16
Hide Description Median percent change from baseline in inflammatory lesion counts (papules/pustules, nodules) at Week 16. Papules and nodules are round, solid elevations of the skin with no visible fluid; papules are smaller (less than 5 to 10 millimeters in width and depth) and nodules are larger (greater than 5 to 10 millimeters in width and depth). Pustules are small elevations of the skin containing cloudy material. A negative number change from baseline indicates a reduction in lesion counts (improvement).
Time Frame Baseline, Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat population included all randomized patients. The number of patients that were analyzed reflects the actual number of patients for which data were available for this outcome measure.
Arm/Group Title Tazarotene Cream 0.1% Adapalene Gel 0.3%
Hide Arm/Group Description:
1 pea-size amount, QD x 16 weeks
1 pea-size amount, QD x 16 weeks
Overall Number of Participants Analyzed 61 72
Median (Full Range)
Unit of Measure: Percent Change
-67.86
(-100.0 to 32.00)
-55.56
(-100.0 to 38.46)
Time Frame [Not Specified]
Adverse Event Reporting Description The safety population was used to calculate the number of participants at risk for SAEs an AEs and is the total number of patients that were randomized AND treated.
 
Arm/Group Title Tazarotene Cream 0.1% Adapalene Gel 0.3%
Hide Arm/Group Description 1 pea-size amount, QD x 16 weeks 1 pea-size amount, QD x 16 weeks
All-Cause Mortality
Tazarotene Cream 0.1% Adapalene Gel 0.3%
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Tazarotene Cream 0.1% Adapalene Gel 0.3%
Affected / at Risk (%) Affected / at Risk (%)
Total   0/72 (0.00%)   0/85 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Tazarotene Cream 0.1% Adapalene Gel 0.3%
Affected / at Risk (%) Affected / at Risk (%)
Total   10/72 (13.89%)   9/85 (10.59%) 
General disorders     
Burning *  4/72 (5.56%)  4/85 (4.71%) 
Infections and infestations     
Cold Symptoms *  6/72 (8.33%)  5/85 (5.88%) 
*
Indicates events were collected by non-systematic assessment
Study enrollment was terminated due to company decision before the target enrollment of 220 patients was reached.
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.
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo
Results Point of Contact
Name/Title: Vice President, Medical Affairs
Organization: Allergan, Inc.
Phone: 714-246-4500
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00829049     History of Changes
Other Study ID Numbers: MA-TAZ0702
First Submitted: January 22, 2009
First Posted: January 26, 2009
Results First Submitted: September 22, 2011
Results First Posted: September 12, 2012
Last Update Posted: September 12, 2012