Trial Outcomes & Findings for Cutivate Lotion HPA Axis Pediatric Study (NCT NCT00546000)
NCT ID: NCT00546000
Last Updated: 2014-07-24
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
56 participants
Primary outcome timeframe
Up to 29 days of treatment
Results posted on
2014-07-24
Participant Flow
Participant milestones
| Measure |
Experimental
Receive between 22 and 29 days of Cutivate lotion treatment
Fluticasone propionate 0.05% lotion: Daily applications
|
|---|---|
|
Overall Study
STARTED
|
56
|
|
Overall Study
COMPLETED
|
52
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Experimental
Receive between 22 and 29 days of Cutivate lotion treatment
Fluticasone propionate 0.05% lotion: Daily applications
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Baseline HPA Axis Supression
|
2
|
Baseline Characteristics
Cutivate Lotion HPA Axis Pediatric Study
Baseline characteristics by cohort
| Measure |
Experimental
n=56 Participants
Receive between 22 and 29 days of Cutivate lotion treatment
Fluticasone propionate 0.05% lotion: Daily applications
|
|---|---|
|
Age, Continuous
|
7.2 Months
STANDARD_DEVIATION 2.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
47 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
7 participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
31 participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
7 participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
56 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 29 days of treatmentThe 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.
Outcome measures
| Measure |
Experimental
n=56 Participants
Receive between 22 and 29 days of Cutivate lotion treatment
Fluticasone propionate 0.05% lotion: Daily applications
|
|---|---|
|
Post Treatment Serum Cortisol Values Will be Compared.
|
1 participants
|
SECONDARY outcome
Timeframe: Over 5-6 visits following the baseline visit through the end of treatment between Day 22-29The 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.
Outcome measures
| Measure |
Experimental
n=56 Participants
Receive between 22 and 29 days of Cutivate lotion treatment
Fluticasone propionate 0.05% lotion: Daily applications
|
|---|---|
|
Record Skin Atrophy, Pigmentation Change, Hematological and Chemistry Assessments, and Changes in Atopic Dermatitis Severity
skin atrophy
|
1 participants
|
|
Record Skin Atrophy, Pigmentation Change, Hematological and Chemistry Assessments, and Changes in Atopic Dermatitis Severity
pigmentation change
|
9 participants
|
Adverse Events
Experimental
Serious events: 1 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Experimental
n=56 participants at risk
Receive between 22 and 29 days of Cutivate lotion treatment
Fluticasone propionate 0.05% lotion: Daily applications
|
|---|---|
|
General disorders
Pyrexia
|
1.8%
1/56 • 29 days
|
Other adverse events
| Measure |
Experimental
n=56 participants at risk
Receive between 22 and 29 days of Cutivate lotion treatment
Fluticasone propionate 0.05% lotion: Daily applications
|
|---|---|
|
Infections and infestations
Gastroenteritis
|
3.6%
2/56 • Number of events 2 • 29 days
|
|
Infections and infestations
Herpes simplex
|
3.6%
2/56 • Number of events 2 • 29 days
|
|
Infections and infestations
Nasopharyngitis
|
3.6%
2/56 • Number of events 3 • 29 days
|
|
Infections and infestations
Upper respiratory tract infection
|
3.6%
2/56 • Number of events 3 • 29 days
|
|
Infections and infestations
Folliculitis
|
1.8%
1/56 • Number of events 1 • 29 days
|
|
Infections and infestations
Impetigo
|
1.8%
1/56 • Number of events 1 • 29 days
|
|
Infections and infestations
Oral candidiasis
|
1.8%
1/56 • Number of events 1 • 29 days
|
|
Infections and infestations
Otitis media
|
1.8%
1/56 • Number of events 1 • 29 days
|
|
Infections and infestations
Staphylococcal infection
|
1.8%
1/56 • Number of events 1 • 29 days
|
|
Gastrointestinal disorders
Constipation
|
1.8%
1/56 • Number of events 1 • 29 days
|
|
Gastrointestinal disorders
Diarrhoea
|
1.8%
1/56 • Number of events 1 • 29 days
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.8%
1/56 • Number of events 1 • 29 days
|
|
Gastrointestinal disorders
Teething
|
1.8%
1/56 • Number of events 1 • 29 days
|
|
General disorders
Pyrexia
|
5.4%
3/56 • Number of events 3 • 29 days
|
|
General disorders
Irritability
|
3.6%
2/56 • Number of events 2 • 29 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.6%
2/56 • Number of events 2 • 29 days
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.8%
1/56 • Number of events 1 • 29 days
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
1.8%
1/56 • Number of events 1 • 29 days
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
1.8%
1/56 • Number of events 1 • 29 days
|
|
Immune system disorders
Hypersensitivity
|
3.6%
2/56 • Number of events 3 • 29 days
|
|
Congenital, familial and genetic disorders
Ichthyosis
|
1.8%
1/56 • Number of events 1 • 29 days
|
|
Eye disorders
Conjunctivitis
|
1.8%
1/56 • Number of events 1 • 29 days
|
|
Reproductive system and breast disorders
Genital rash
|
1.8%
1/56 • Number of events 1 • 29 days
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
1.8%
1/56 • Number of events 1 • 29 days
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
1.8%
1/56 • Number of events 1 • 29 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER