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Trial record 5 of 810 for:    Psoriasis 4

Taclonex Ointment With Hydrogel Patch Occlusion for the Treatment of Psoriasis

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ClinicalTrials.gov Identifier: NCT00924950
Recruitment Status : Terminated
First Posted : June 19, 2009
Results First Posted : December 5, 2012
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Plaque Psoriasis
Psoriasis Vulgaris
Interventions Drug: Taclonex Ointment and Hydrogel Patch
Drug: Taclonex Ointment
Enrollment 35
Recruitment Details Recruitment took place at the University of California at San Francisco (UCSF) Psoriasis and Skin Treatment Center.
Pre-assignment Details Patients were assessed for psoriasis severity as well as washout from other concomitant medications
Arm/Group Title Ointment + Patch vs. Ointment Alone
Hide Arm/Group Description Taclonex (calcipotriene 0.005% and betamethasone dipropionate 0.064%) ointment used topically to treat one psoriatic plaque with Hydrogel patch used over for occlusion for 6-8 hours daily. Within the same patient another patch of similar severity was chosen and was treated with Taclonex ointment alone without hydrogel patch occlusion
Period Title: Overall Study
Started 30
Completed 28
Not Completed 2
Reason Not Completed
Lost to Follow-up             2
Arm/Group Title Ointment + Patch vs. Ointment Alone
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
<=18 years
0
   0.0%
Between 18 and 65 years
30
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female NA [1] 
Male NA [1] 
[1]
Gender was not measured in each arm
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 30 participants
30
1.Primary Outcome
Title Change in Total Modified PASI Score at Week 4 Compared to Baseline
Hide Description Modified psoriasis severity index measures erythema, induration, and scaling each measured from 0-4, with a maximum summed score of 12. A higher score means greater psoriasis severity and a lower score means lower psoriasis severity.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants was chosen by our budget restrictions. 35 patients were enrolled. 5 patients were lost to follow-up.
Arm/Group Title Taclonex Ointment Occluded With Hydrogel Patch Taclonex Alone
Hide Arm/Group Description:
Taclonex (calcipotriene 0.005% and betamethasone dipropionate 0.064%) ointment used daily topically to treat one psoriatic plaque, occluded with hydrogel patch for 6-8 hours each day.
Taclonex (calcipotriene 0.005% and betamethasone dipropionate 0.064%) ointment used daily without hydrogel patch.
Overall Number of Participants Analyzed 30 30
Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
0.86
(0.40 to 1.31)
2.2
(1.7 to 3.58)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Taclonex Ointment Occluded With Hydrogel Patch, Taclonex Alone
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0008
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.8571
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change in Modified PASI Scores Between Week 4 and Week 6 During the Follow-up Period. This is to Determine Whether There is Further Improvement of Psoriasis After the Cessation of Occlusion
Hide Description Change in Modified PASI Scores Between Week 4 and Week 6 During the Follow-up Period. This is to Determine Whether There is Further Improvement of Psoriasis After the Cessation of Occlusion.
Time Frame 6 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome measure was not analyzed due to termination of the study
Arm/Group Title Taclonex Ointment/Hydrogel Patch Applied Topically Once Daily Taclonex Ointment Topically Once Daily
Hide Arm/Group Description:

Taclonex ointment once daily used to treat one psoriatic plaque, along with the Hydrogel Patch used once daily.

Taclonex Ointment and Hydrogel Patch: Each patient will have bilateral symmetrical psoriatic plaques. One plaque will be treated with Taclonex Ointment daily along with Hydrogel Patch daily. All treatment will be for 4 weeks.

Taclonex Ointment: Taclonex ointment daily for one psoriatic plaque.
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 Ointment + Patch vs. Ointment Alone
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
Ointment + Patch vs. Ointment Alone
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Ointment + Patch vs. Ointment Alone
Affected / at Risk (%)
Total   0/30 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ointment + Patch vs. Ointment Alone
Affected / at Risk (%)
Total   0/30 (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: Tina Bhutani
Organization: UCSF
Phone: 4154763396
EMail: tinabhutanimd@gmail.com
Layout table for additonal information
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00924950     History of Changes
Other Study ID Numbers: H5939-31328-02
First Submitted: June 17, 2009
First Posted: June 19, 2009
Results First Submitted: August 4, 2011
Results First Posted: December 5, 2012
Last Update Posted: April 18, 2019