Trial Outcomes & Findings for Effect of Topical Calcipotriene/Betamethasone (Taclonex) in Managing Localized Breakthrough in Moderate to Severe Plaque Psoriasis in Patients Receiving Efalizumab (Raptiva) (NCT NCT00608777)

NCT ID: NCT00608777

Last Updated: 2012-08-10

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

6 participants

Primary outcome timeframe

week 2

Results posted on

2012-08-10

Participant Flow

Recruitment from January 2008 through December 2008. Subjects recruited from physician data base.

Subjects experiencing mild localized breakthrough associated with Raptiva use were recruited.

Participant milestones

Participant milestones
Measure
Open Label Taclonex
Overall Study
STARTED
6
Overall Study
COMPLETED
6
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Topical Calcipotriene/Betamethasone (Taclonex) in Managing Localized Breakthrough in Moderate to Severe Plaque Psoriasis in Patients Receiving Efalizumab (Raptiva)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Open Label Taclonex
n=6 Participants
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
5 Participants
n=5 Participants
Age, Categorical
>=65 years
1 Participants
n=5 Participants
Sex: Female, Male
Female
2 Participants
n=5 Participants
Sex: Female, Male
Male
4 Participants
n=5 Participants
Region of Enrollment
United States
6 participants
n=5 Participants

PRIMARY outcome

Timeframe: week 2

Outcome measures

Outcome data not reported

Adverse Events

Open Label

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Leon Kircik, M.D.

DermResearch, PLLC

Phone: 502-5451-9000

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place