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Cutivate Lotion HPA Axis Pediatric Study

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: NCT00546000
Recruitment Status : Completed
First Posted : October 18, 2007
Results First Posted : July 24, 2014
Last Update Posted : July 24, 2014
Sponsor:
Information provided by (Responsible Party):
Fougera Pharmaceuticals Inc.

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Atopic Dermatitis
Intervention Drug: Fluticasone propionate 0.05% lotion
Enrollment 56
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Experimental
Hide Arm/Group Description

Receive between 22 and 29 days of Cutivate lotion treatment

Fluticasone propionate 0.05% lotion: Daily applications

Period Title: Overall Study
Started 56
Completed 52
Not Completed 4
Reason Not Completed
Adverse Event             1
Lost to Follow-up             1
Baseline HPA Axis Supression             2
Arm/Group Title Experimental
Hide Arm/Group Description

Receive between 22 and 29 days of Cutivate lotion treatment

Fluticasone propionate 0.05% lotion: Daily applications

Overall Number of Baseline Participants 56
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 56 participants
7.2  (2.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants
Female
18
  32.1%
Male
38
  67.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants
Hispanic or Latino
9
  16.1%
Not Hispanic or Latino
47
  83.9%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 56 participants
American Indian or Alaska Native 1
Asian 7
Native Hawaiian or Other Pacific Islander 0
Black or African American 31
White 19
More than one race 7
Unknown or Not Reported 3
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 56 participants
56
1.Primary Outcome
Title Post Treatment Serum Cortisol Values Will be Compared.
Hide Description The primary safety parameter was the response to the CST at the end of treatment/final visit. Blood samples were collected prior to injection of cosyntropin and post-injection. Post-CST stimulation cortisol level ≤ 18micrograms/dL was considered as evidence of adrenal suppression.
Time Frame Up to 29 days of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Experimental
Hide Arm/Group Description:

Receive between 22 and 29 days of Cutivate lotion treatment

Fluticasone propionate 0.05% lotion: Daily applications

Overall Number of Participants Analyzed 56
Measure Type: Number
Unit of Measure: participants
1
2.Secondary Outcome
Title Record Skin Atrophy, Pigmentation Change, Hematological and Chemistry Assessments, and Changes in Atopic Dermatitis Severity
Hide Description The frequency distributions of the presence/absence of adverse events associated with signs of atrophy and pigmentation changes were summarized with frequency counts. Hematology and Chemistry Assessments were summarized in shift tables. Signs and symptoms of AD were summarized at each visit.
Time Frame Over 5-6 visits following the baseline visit through the end of treatment between Day 22-29
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Experimental
Hide Arm/Group Description:

Receive between 22 and 29 days of Cutivate lotion treatment

Fluticasone propionate 0.05% lotion: Daily applications

Overall Number of Participants Analyzed 56
Measure Type: Number
Unit of Measure: participants
skin atrophy 1
pigmentation change 9
Time Frame 29 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Experimental
Hide Arm/Group Description

Receive between 22 and 29 days of Cutivate lotion treatment

Fluticasone propionate 0.05% lotion: Daily applications

All-Cause Mortality
Experimental
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Experimental
Affected / at Risk (%) # Events
Total   1/56 (1.79%)    
General disorders   
Pyrexia  1/56 (1.79%) 
1
Term from vocabulary, MedDRA SOC
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Experimental
Affected / at Risk (%) # Events
Total   25/56 (44.64%)    
Congenital, familial and genetic disorders   
Ichthyosis  1/56 (1.79%)  1
Eye disorders   
Conjunctivitis  1/56 (1.79%)  1
Gastrointestinal disorders   
Constipation  1/56 (1.79%)  1
Diarrhoea  1/56 (1.79%)  1
Gastrooesophageal reflux disease  1/56 (1.79%)  1
Teething  1/56 (1.79%)  1
General disorders   
Pyrexia  3/56 (5.36%)  3
Irritability  2/56 (3.57%)  2
Immune system disorders   
Hypersensitivity  2/56 (3.57%)  3
Infections and infestations   
Gastroenteritis  2/56 (3.57%)  2
Herpes simplex  2/56 (3.57%)  2
Nasopharyngitis  2/56 (3.57%)  3
Upper respiratory tract infection  2/56 (3.57%)  3
Folliculitis  1/56 (1.79%)  1
Impetigo  1/56 (1.79%)  1
Oral candidiasis  1/56 (1.79%)  1
Otitis media  1/56 (1.79%)  1
Staphylococcal infection  1/56 (1.79%)  1
Reproductive system and breast disorders   
Genital rash  1/56 (1.79%)  1
Respiratory, thoracic and mediastinal disorders   
Cough  2/56 (3.57%)  2
Nasal congestion  1/56 (1.79%)  1
Rhinorrhoea  1/56 (1.79%)  1
Wheezing  1/56 (1.79%)  1
Skin and subcutaneous tissue disorders   
Dermatitis diaper  1/56 (1.79%)  1
Skin fissures  1/56 (1.79%)  1
1
Term from vocabulary, MedDRA SOC
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: Angela C. Kaplan
Organization: Fougera Pharmaceuticals Inc.
Phone: 631-659-2256
EMail: angela.kaplan@sandoz.com
Layout table for additonal information
Responsible Party: Fougera Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00546000    
Other Study ID Numbers: ALT 0434-01-01
First Submitted: October 16, 2007
First Posted: October 18, 2007
Results First Submitted: June 25, 2014
Results First Posted: July 24, 2014
Last Update Posted: July 24, 2014