Trial Outcomes & Findings for A Plaque Test Comparing the Anti-psoriatic Effect of Marketed Products for Topical Use for Psoriasis Vulgaris (NCT NCT00845481)

NCT ID: NCT00845481

Last Updated: 2025-03-12

Results Overview

The Total Clinical Score is the sum of three psoriasis scores (redness, thickness, and scaliness) and will range from 0 (best) to 9 (worst)

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

24 participants

Primary outcome timeframe

Baseline and 3 weeks

Results posted on

2025-03-12

Participant Flow

Participant milestones

Participant milestones
Measure
Patients Treated
Treatments are given at the same time on different locations of the skin with psoriasis in the same group of participants.
Overall Study
STARTED
24
Overall Study
COMPLETED
24
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Plaque Test Comparing the Anti-psoriatic Effect of Marketed Products for Topical Use for Psoriasis Vulgaris

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Patients Treated
n=24 Participants
Treatments are given at the same time on different locations of the skin with psoriasis in the same group of participants.
Age, Continuous
50.5 years
STANDARD_DEVIATION 9.6 • n=99 Participants
Age, Customized
<=18 years
0 participants
n=99 Participants
Age, Customized
Between 18 and 67 years
23 participants
n=99 Participants
Age, Customized
>=68 years
1 participants
n=99 Participants
Sex: Female, Male
Female
8 Participants
n=99 Participants
Sex: Female, Male
Male
16 Participants
n=99 Participants
Region of Enrollment
France
24 participants
n=99 Participants

PRIMARY outcome

Timeframe: Baseline and 3 weeks

The Total Clinical Score is the sum of three psoriasis scores (redness, thickness, and scaliness) and will range from 0 (best) to 9 (worst)

Outcome measures

Outcome measures
Measure
Patients Treated With Daivobet® Ointment
n=24 Participants
Treatments are given at the same time on different locations of the skin with psoriasis in the same group of participants. The treatment for this outcome measure is Daivobet® ointment
The Absolute Change in Total Clinical Score (TCS) at End of Treatment Compared to Baseline for Daivobet® Ointment
-5.15 Scores on a scale
Standard Error 1.31

PRIMARY outcome

Timeframe: Baseline and 3 weeks

The Total Clinical Score is the sum of three psoriasis scores (redness, thickness, and scaliness) and will range from 0 (best) to 9 (worst)

Outcome measures

Outcome measures
Measure
Patients Treated With Daivobet® Ointment
n=24 Participants
Treatments are given at the same time on different locations of the skin with psoriasis in the same group of participants. The treatment for this outcome measure is Daivobet® ointment
The Absolute Change in Total Clinical Score (TCS) at End of Treatment Compared to Baseline for Betnovat® Ointment
-3.33 Scores on a scale
Standard Error 2.44

PRIMARY outcome

Timeframe: Baseline and 3 weeks

The Total Clinical Score is the sum of three psoriasis scores (redness, thickness, and scaliness) and will range from 0 (best) to 9 (worst)

Outcome measures

Outcome measures
Measure
Patients Treated With Daivobet® Ointment
n=24 Participants
Treatments are given at the same time on different locations of the skin with psoriasis in the same group of participants. The treatment for this outcome measure is Daivobet® ointment
The Absolute Change in Total Clinical Score (TCS) at End of Treatment Compared to Baseline for Elocon Ointment
-4.50 Scores on a scale
Standard Error 1.74

PRIMARY outcome

Timeframe: Baseline and 3 weeks

The Total Clinical Score is the sum of three psoriasis scores (redness, thickness, and scaliness) and will range from 0 (best) to 9 (worst)

Outcome measures

Outcome measures
Measure
Patients Treated With Daivobet® Ointment
n=24 Participants
Treatments are given at the same time on different locations of the skin with psoriasis in the same group of participants. The treatment for this outcome measure is Daivobet® ointment
The Absolute Change in Total Clinical Score (TCS) at End of Treatment Compared to Baseline for Daivobet Ointment Vehicle
-1.91 Scores on a scale
Standard Error 1.15

PRIMARY outcome

Timeframe: Baseline and 3 weeks

The Total Clinical Score is the sum of three psoriasis scores (redness, thickness, and scaliness) and will range from 0 (best) to 9 (worst)

Outcome measures

Outcome measures
Measure
Patients Treated With Daivobet® Ointment
n=24 Participants
Treatments are given at the same time on different locations of the skin with psoriasis in the same group of participants. The treatment for this outcome measure is Daivobet® ointment
The Absolute Change in Total Clinical Score (TCS) at End of Treatment Compared to Baseline for Dermovat Ointment
-5.71 Scores on a scale
Standard Error 1.39

PRIMARY outcome

Timeframe: Baseline and 3 weeks

The Total Clinical Score is the sum of three psoriasis scores (redness, thickness, and scaliness) and will range from 0 (best) to 9 (worst)

Outcome measures

Outcome measures
Measure
Patients Treated With Daivobet® Ointment
n=24 Participants
Treatments are given at the same time on different locations of the skin with psoriasis in the same group of participants. The treatment for this outcome measure is Daivobet® ointment
The Absolute Change in Total Clinical Score (TCS) at End of Treatment Compared to Baseline for Diprosalic Ointment
-4.50 Scores on a scale
Standard Error 1.84

Adverse Events

Patients Treated

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

Torsten Skov, Senior Medical Advisor

LEO Pharma

Phone: +45 20 73 62 94

Results disclosure agreements

  • Principal investigator is a sponsor employee LEO retains the right to publish the results of this clinical trial
  • Publication restrictions are in place

Restriction type: OTHER