Trial Outcomes & Findings for Taclonex Ointment With Hydrogel Patch Occlusion for the Treatment of Psoriasis (NCT NCT00924950)
NCT ID: NCT00924950
Last Updated: 2019-04-18
Results Overview
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.
TERMINATED
PHASE4
35 participants
4 weeks
2019-04-18
Participant Flow
Recruitment took place at the University of California at San Francisco (UCSF) Psoriasis and Skin Treatment Center.
Patients were assessed for psoriasis severity as well as washout from other concomitant medications
Participant milestones
| Measure |
Ointment + Patch vs. Ointment Alone
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
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
28
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Ointment + Patch vs. Ointment Alone
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
|
|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
Baseline Characteristics
Taclonex Ointment With Hydrogel Patch Occlusion for the Treatment of Psoriasis
Baseline characteristics by cohort
| Measure |
Ointment + Patch vs. Ointment Alone
n=30 Participants
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
NA Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
NA Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: The number of participants was chosen by our budget restrictions. 35 patients were enrolled. 5 patients were lost to follow-up.
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.
Outcome measures
| Measure |
Taclonex Ointment Occluded With Hydrogel Patch
n=30 Participants
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 Alone
n=30 Participants
Taclonex (calcipotriene 0.005% and betamethasone dipropionate 0.064%) ointment used daily without hydrogel patch.
|
|---|---|---|
|
Change in Total Modified PASI Score at Week 4 Compared to Baseline
|
0.86 Units on a scale
Interval 0.4 to 1.31
|
2.2 Units on a scale
Interval 1.7 to 3.58
|
SECONDARY outcome
Timeframe: 6 WeeksPopulation: This outcome measure was not analyzed due to termination of the study
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.
Outcome measures
Outcome data not reported
Adverse Events
Ointment + Patch vs. Ointment Alone
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place