Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 57 of 233 for:    acne AND Percent

Bioequivalence Study of Generic Tretinoin 0.04% Microsphere Gel, 0.04% Retin-A Micro® and Placebo

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: NCT01243450
Recruitment Status : Completed
First Posted : November 18, 2010
Results First Posted : November 18, 2014
Last Update Posted : November 18, 2014
Sponsor:
Information provided by (Responsible Party):
Spear Pharmaceuticals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Acne
Interventions Drug: Tretinoin
Drug: placebo
Enrollment 958
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Active Generic Placebo Brand
Hide Arm/Group Description

active cream

Tretinoin: Topical skin

placebo cream

Tretinoin: Topical skin

placebo

Tretinoin: Topical skin
Period Title: Overall Study
Started 401 135 404
Completed 318 110 337
Not Completed 83 25 67
Arm/Group Title Active Generic Brand Placebo Total
Hide Arm/Group Description Active generic group Brand group Placebo group Total of all reporting groups
Overall Number of Baseline Participants 401 404 135 940
Hide Baseline Analysis Population Description
number of acne lesions by counting
Age, Continuous  
Median (Standard Deviation)
Unit of measure:  Years
Number Analyzed 401 participants 404 participants 135 participants 940 participants
17.2  (6.2) 17.1  (6.1) 17.6  (6.3) 17.2  (6.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 401 participants 404 participants 135 participants 940 participants
Female
193
  48.1%
211
  52.2%
80
  59.3%
484
  51.5%
Male
208
  51.9%
193
  47.8%
55
  40.7%
456
  48.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 401 participants 404 participants 135 participants 940 participants
401 404 135 940
1.Primary Outcome
Title Acne Lesion Percent Reduction
Hide Description Reduction in number of Acne lesions by counting over 12 weeks
Time Frame 12 week
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Generic Placebo Brand
Hide Arm/Group Description:

active cream

Tretinoin: Topical skin

placebo cream

Tretinoin: Topical skin

placebo

Tretinoin: Topical skin
Overall Number of Participants Analyzed 318 110 337
Mean (Standard Deviation)
Unit of Measure: percent reduction of number of lesions
-54.3  (10) -35  (8) -53.5  (10)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Active Generic Placebo Brand
Hide Arm/Group Description

active cream

Tretinoin: Topical skin

placebo cream

Tretinoin: Topical skin

placebo

Tretinoin: Topical skin
All-Cause Mortality
Active Generic Placebo Brand
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Active Generic Placebo Brand
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/401 (0.25%)      0/135 (0.00%)      1/404 (0.25%)    
Gastrointestinal disorders       
Appendicitis  [1]  1/401 (0.25%)  1 0/135 (0.00%)  0 1/404 (0.25%)  1
Indicates events were collected by systematic assessment
[1]
appendicitis
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Active Generic Placebo Brand
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/401 (0.00%)      0/135 (0.00%)      0/404 (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
Name/Title: William J. Cunningham, MD
Organization: Cu-Tech, LLC
Phone: (973) 331-1620
Responsible Party: Spear Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01243450     History of Changes
Other Study ID Numbers: RAM-04
First Submitted: November 16, 2010
First Posted: November 18, 2010
Results First Submitted: September 7, 2014
Results First Posted: November 18, 2014
Last Update Posted: November 18, 2014