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Trial record 33 of 141 for:    acne AND erythema

Comparison of Two Salicylic Acid Formulations

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: NCT00848744
Recruitment Status : Completed
First Posted : February 20, 2009
Results First Posted : July 5, 2010
Last Update Posted : March 1, 2018
Sponsor:
Collaborator:
Ann & Robert H Lurie Children's Hospital of Chicago
Information provided by (Responsible Party):
Amy Paller, Northwestern University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Acne Vulgaris
Interventions Drug: Formulation A
Drug: Formulation B
Enrollment 10
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Salicylic Acid
Hide Arm/Group Description Participants used salicylic acid Formulation A and B randomized to opposite sides fo the face.on
Period Title: Overall Study
Started 10
Completed 10
Not Completed 0
Arm/Group Title Salicylic Acid
Hide Arm/Group Description Participants used salicylic acid Formulation A and B randomized to opposite sides fo the face.on
Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
<=18 years
6
  60.0%
Between 18 and 65 years
4
  40.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
6
  60.0%
Male
4
  40.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants
10
1.Primary Outcome
Title Physician Global Assessment
Hide Description Difference in physician global assessment between two formulations. We remain blinded as to which formulation, both containing salicylic acid, worked better on patients. Measure is a scale (not an option below). Best was 0 (clear), worst was 4 (severe).
Time Frame 28 days; The visits include baseline, Day 2, Day 7 (+/- 1) and Day 28 (+/- 3).
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was per protocol. Each subject received formulations A and B randomized to opposite sides of the face.
Arm/Group Title Salicylic Acid Formulation B
Hide Arm/Group Description:
Participants used salicylic acid Formulation A and B randomized to opposite sides fo the face.on
Participants used salicylic acid Formulation A on either the right or left side of the face.
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 2.65  (0.41) 2.6  (0.52)
Day 2 2.55  (0.44) 2.45  (0.55)
Day 7 2.4  (0.61) 2.3  (0.59)
Day 28 2.20  (0.63) 2.15  (0.58)
2.Secondary Outcome
Title The Subject's Medication Side Effect Profile Will be Assessed Using a Application Site Scale for Dryness, Scaling, Redness, and Stinging/Burning.
Hide Description [Not Specified]
Time Frame 4 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected.
Arm/Group Title Salicylic Acid Formulation B
Hide Arm/Group Description:
Participants used salicylic acid Formulation A and B randomized to opposite sides fo the face.on
Participants used salicylic acid Formulation A on either the right or left side of the face.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Salicylic Acid
Hide Arm/Group Description Participants used salicylic acid Formulation A and B randomized to opposite sides fo the face.on
All-Cause Mortality
Salicylic Acid
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Salicylic Acid
Affected / at Risk (%) # Events
Total   0/10 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Salicylic Acid
Affected / at Risk (%) # Events
Total   1/10 (10.00%)    
Skin and subcutaneous tissue disorders   
irritation and swelling of face  [1]  1/10 (10.00%)  1
Indicates events were collected by systematic assessment
[1]
Subject reported irritation and swelling on the 25th day of study drug use. The symptoms improved after she stopped the study drug within 2 days. She resumed use of study drug and no further reactions were noted.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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: Dermatology CTU
Organization: Northwestern University
Phone: 312-503-5944
Responsible Party: Amy Paller, Northwestern University
ClinicalTrials.gov Identifier: NCT00848744     History of Changes
Other Study ID Numbers: AP-011008
First Submitted: November 24, 2008
First Posted: February 20, 2009
Results First Submitted: November 10, 2009
Results First Posted: July 5, 2010
Last Update Posted: March 1, 2018