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Adherence to Topical Hydrocortisone 17-butyrate 0.1% (Locoid®) Using Different Vehicles in Adults With Atopic Dermatitis

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ClinicalTrials.gov Identifier: NCT00693693
Recruitment Status : Completed
First Posted : June 9, 2008
Results First Posted : March 17, 2017
Last Update Posted : September 10, 2018
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences ( Wake Forest University )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Atopic Dermatitis
Interventions Drug: hydrocortisone 17-butyrate 0.1% Cream preparation
Drug: hydrocortisone 17-butyrate 0.1% Ointment preparation
Drug: hydrocortisone 17-butyrate 0.1% Lipocream preparation
Enrollment 26
Recruitment Details Participants were recruited from IRB approved advertising and the Dermatology Clinic.
Pre-assignment Details  
Arm/Group Title Ointment Lipocream Cream
Hide Arm/Group Description topical hydrocortisone 17-butyrate 0.1% preparation ointment topical hydrocortisone 17-butyrate 0.1% preparation lipocream topical hydrocortisone 17-butyrate 0.1% preparation cream
Period Title: Overall Study
Started 7 9 9
Completed 6 8 7
Not Completed 1 1 2
Reason Not Completed
Lost to Follow-up             1             1             2
Arm/Group Title Cream Ointment Lipocream Total
Hide Arm/Group Description topical hydrocortisone 17-butyrate 0.1% cream applied twice daily topical hydrocortisone 17-butyrate 0.1% ointment applied twice daily topical hydrocortisone 17-butyrate 0.1% Lipocream applied twice daily Total of all reporting groups
Overall Number of Baseline Participants 9 7 9 25
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 7 participants 9 participants 25 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
9
 100.0%
7
 100.0%
9
 100.0%
25
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 7 participants 9 participants 25 participants
Female
5
  55.6%
4
  57.1%
5
  55.6%
14
  56.0%
Male
4
  44.4%
3
  42.9%
4
  44.4%
11
  44.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 9 participants 7 participants 9 participants 25 participants
9 7 9 21
1.Primary Outcome
Title Adherence to Locoid
Hide Description Adherence measured by MEMS cap as the % of days that the two total prescribed doses were applied
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cream Ointment Lipocream
Hide Arm/Group Description:
topical hydrocortisone 17-butyrate 0.1% cream applied twice daily to all areas of atopic dermatitis
topical hydrocortisone 17-butyrate 0.1% ointment applied twice daily to all areas of atopic dermatitis
topical hydrocortisone 17-butyrate 0.1% Lipocream applied twice daily to all areas of atopic dermatitis
Overall Number of Participants Analyzed 6 7 8
Mean (Standard Deviation)
Unit of Measure: percentage of days
.55  (.07) .60  (.07) .50  (.07)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Topical Hydrocortisone 17-butyrate 0.1% Cream Topical Hydrocortisone 17-butyrate 0.1% Ointment Topical Hydrocortisone 17-butyrate 0.1% Lipocream
Hide Arm/Group Description topical hydrocortisone 17-butyrate 0.1% cream applied twice daily topical hydrocortisone 17-butyrate 0.1% ointment applied twice daily topical hydrocortisone 17-butyrate 0.1% lipocream applied twice daily
All-Cause Mortality
Topical Hydrocortisone 17-butyrate 0.1% Cream Topical Hydrocortisone 17-butyrate 0.1% Ointment Topical Hydrocortisone 17-butyrate 0.1% Lipocream
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/7 (0.00%)   0/8 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Topical Hydrocortisone 17-butyrate 0.1% Cream Topical Hydrocortisone 17-butyrate 0.1% Ointment Topical Hydrocortisone 17-butyrate 0.1% Lipocream
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/7 (0.00%)   0/8 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Topical Hydrocortisone 17-butyrate 0.1% Cream Topical Hydrocortisone 17-butyrate 0.1% Ointment Topical Hydrocortisone 17-butyrate 0.1% Lipocream
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/7 (0.00%)   0/8 (0.00%) 
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
Layout table for Results Point of Contact information
Name/Title: Steven Feldman, MD, PhD
Organization: Wake Forest University Health Sciences
Phone: 336-716-3775
EMail: sfeldman@wfubmc.edu
Layout table for additonal information
Responsible Party: Wake Forest University Health Sciences ( Wake Forest University )
ClinicalTrials.gov Identifier: NCT00693693     History of Changes
Other Study ID Numbers: IRB00000702
First Submitted: June 5, 2008
First Posted: June 9, 2008
Results First Submitted: January 27, 2017
Results First Posted: March 17, 2017
Last Update Posted: September 10, 2018