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Trial record 44 of 163 for:    ISOTRETINOIN

Musculoskeletal Effects of Isotretinoin During Acne Treatment in Pediatric Population

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ClinicalTrials.gov Identifier: NCT00964119
Recruitment Status : Terminated (Principal Investigator has left Sponsoring Instiution)
First Posted : August 24, 2009
Results First Posted : February 23, 2015
Last Update Posted : February 23, 2015
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Prospective
Condition Acne
Enrollment 15
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Single Cohort Obervational
Hide Arm/Group Description [Not Specified]
Period Title: Overall Study
Started 15
Completed 15
Not Completed 0
Arm/Group Title Single Cohort Observational
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
Adolescents and young adults treated with systemic isotretinoin for recalcitrant inflammatory or nodular cystic acne.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
<=18 years
14
  93.3%
Between 18 and 65 years
1
   6.7%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
4
  26.7%
Male
11
  73.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants
15
1.Primary Outcome
Title Skeletal Toxicities Related to the Use of Isotretinoin
Hide Description Bone Marker measurements to assess skeletal toxicities: Change in Bone specific Alkaline Phosphatase: (BSAP) over 5 months of therapy
Time Frame Baseline to 5 months post therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Pilot observational study; Principal Investigator left sponsoring institution, data analysis not completed. Data analysis based on interim data (12 subjects). No manuscript published. No final analysis expected. Study has been closed with the local IRB and files archived.
Arm/Group Title Single Cohort Observational
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: U/L
Baseline BSAP 62.73  (35.86)
post 5 month isotretinoin therapy 51.80  (24.26)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Single Cohort Observational
Comments PI and lead author left the institution before publishing data. Study has been closed and data files archived.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.05
Comments P-value < .05 is the computed p-value for this measurement.
Method t-test, 2 sided
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Single Cohort Observational
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
Single Cohort Observational
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Single Cohort Observational
Affected / at Risk (%) # Events
Total   0/15 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Single Cohort Observational
Affected / at Risk (%) # Events
Total   8/15 (53.33%)    
Musculoskeletal and connective tissue disorders   
Arthralgia  [1]  8/15 (53.33%)  8
Indicates events were collected by systematic assessment
[1]
(full body questionnaire)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dermatology Clinical Trials Administrator
Organization: University of Wisconsin - Madison
Phone: 608-287-2640
EMail: dbock@dermatology.wisc.edu
Layout table for additonal information
Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00964119     History of Changes
Other Study ID Numbers: H-2008-0106
First Submitted: August 21, 2009
First Posted: August 24, 2009
Results First Submitted: December 5, 2014
Results First Posted: February 23, 2015
Last Update Posted: February 23, 2015