Trial Outcomes & Findings for A Short-contact Plaque Test Study With Daivobet® Gel in Psoriasis Vulgaris (NCT NCT01607853)
NCT ID: NCT01607853
Last Updated: 2025-03-10
Results Overview
Investigator's rating of the clinical appearance of a psoriatic lesion. Maximum score is 9 (most severe); minimum score is 0 (least severe). The single items erythema, scaling, and infiltration (maximum score 3 each) are summed to obtain the Total Clincal Score
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
24 participants
Primary outcome timeframe
baseline to day 22
Results posted on
2025-03-10
Participant Flow
Start date: 28-Jun-2012 Completion date: 15-Oct-2012
Prior to randomisation, the subjects entered a washout phase (if required) where antipsoriatic treatment and other relevant treatments had to be discontinued as defined by the exclusion criteria. Depending on prior use of disallowed treatments, the washout phase could last for up to 21 days.
Participant milestones
| Measure |
Daivobet® Gel
Each of the 24 subjects participating in this exploratory trial received:
* Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks
* Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
* Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks
* Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
|---|---|
|
Overall Study
STARTED
|
24
|
|
Overall Study
COMPLETED
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Short-contact Plaque Test Study With Daivobet® Gel in Psoriasis Vulgaris
Baseline characteristics by cohort
| Measure |
Daivobet® Gel
n=24 Participants
Each of the 24 subjects participating in this exploratory trial received:
* Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks
* Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
* Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks
* Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
|
Age, Continuous
|
46.7 years
STANDARD_DEVIATION 14.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
24 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline to day 22Investigator's rating of the clinical appearance of a psoriatic lesion. Maximum score is 9 (most severe); minimum score is 0 (least severe). The single items erythema, scaling, and infiltration (maximum score 3 each) are summed to obtain the Total Clincal Score
Outcome measures
| Measure |
Daivobet® Gel Applied Then Removed After 10 Minutes
n=24 Participants
Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
Daivobet® Gel Applied Then Removed After 20 Minutes
n=24 Participants
\- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
Daivobet® Gel Applied for 24 Hours
n=24 Participants
\- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
Daivobet® Gel Vehicle Applied for 24 Hours
n=24 Participants
Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
|---|---|---|---|---|
|
Change in Total Clinical Score From Baseline to Day 22
|
-3.6 units on a scale
Standard Deviation 1.6
|
-3.7 units on a scale
Standard Deviation 2.0
|
-4.9 units on a scale
Standard Deviation 1.5
|
-1.3 units on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: Baseline to day 4Investigator's rating of the clinical appearance of a psoriatic lesion. Maximum score is 9 (most severe); minimum score is 0 (least severe). The single items erythema, scaling, and infiltration (maximum score 3 each) are summed to obtain the Total Clinical Score.
Outcome measures
| Measure |
Daivobet® Gel Applied Then Removed After 10 Minutes
n=24 Participants
Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
Daivobet® Gel Applied Then Removed After 20 Minutes
n=24 Participants
\- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
Daivobet® Gel Applied for 24 Hours
n=24 Participants
\- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
Daivobet® Gel Vehicle Applied for 24 Hours
n=24 Participants
Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
|---|---|---|---|---|
|
Change in Total Clinical Score at Day 4 Compared to Baseline
|
-0.5 units on a scale
Standard Deviation 0.8
|
-0.5 units on a scale
Standard Deviation 0.6
|
-0.4 units on a scale
Standard Deviation 0.7
|
-0.1 units on a scale
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: Baseline to day 8Investigator's rating of the clinical appearance of a psoriatic lesion. Maximum score is 9 (most severe); minimum score is 0 (least severe). The single items erythema, scaling, and infiltration (maximum score 3 each) are summed to obtain the Total Clinical Score.
Outcome measures
| Measure |
Daivobet® Gel Applied Then Removed After 10 Minutes
n=24 Participants
Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
Daivobet® Gel Applied Then Removed After 20 Minutes
n=24 Participants
\- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
Daivobet® Gel Applied for 24 Hours
n=24 Participants
\- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
Daivobet® Gel Vehicle Applied for 24 Hours
n=24 Participants
Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
|---|---|---|---|---|
|
Change in Total Clinical Score at Day 8 Compared to Baseline
|
-1.5 units on a scale
Standard Deviation 1.2
|
-1.4 units on a scale
Standard Deviation 1.4
|
-1.6 units on a scale
Standard Deviation 1.3
|
-0.2 units on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: Baseline to day 11Investigator's rating of the clinical appearance of a psoriatic lesion. Maximum score is 9 (most severe); minimum score is 0 (least severe). The single items erythema, scaling, and infiltration (maximum score 3 each) are summed to obtain the Total Clinical Score.
Outcome measures
| Measure |
Daivobet® Gel Applied Then Removed After 10 Minutes
n=24 Participants
Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
Daivobet® Gel Applied Then Removed After 20 Minutes
n=24 Participants
\- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
Daivobet® Gel Applied for 24 Hours
n=24 Participants
\- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
Daivobet® Gel Vehicle Applied for 24 Hours
n=24 Participants
Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
|---|---|---|---|---|
|
Change in Total Clinical Score at Day 11 Compared to Baseline
|
-2.3 units on a scale
Standard Deviation 1.4
|
-2.3 units on a scale
Standard Deviation 1.4
|
-3.0 units on a scale
Standard Deviation 1.4
|
-0.7 units on a scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Baseline to day 15Investigator's rating of the clinical appearance of a psoriatic lesion. Maximum score is 9 (most severe); minimum score is 0 (least severe). The single items erythema, scaling, and infiltration (maximum score 3 each) are summed to obtain the Total Clinial Score.
Outcome measures
| Measure |
Daivobet® Gel Applied Then Removed After 10 Minutes
n=24 Participants
Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
Daivobet® Gel Applied Then Removed After 20 Minutes
n=24 Participants
\- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
Daivobet® Gel Applied for 24 Hours
n=24 Participants
\- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
Daivobet® Gel Vehicle Applied for 24 Hours
n=24 Participants
Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
|---|---|---|---|---|
|
Change in Total Clinical Score at Day 15 Compared to Baseline
|
-3.0 units on a scale
Standard Deviation 1.3
|
-2.8 units on a scale
Standard Deviation 1.6
|
-3.9 units on a scale
Standard Deviation 1.5
|
-0.9 units on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: Baseline to day 18Investigator's rating of the clinical appearance of a psoriatic lesion. Maximum score is 9 (most severe); minimum score is 0 (least severe). The single items erythema, scaling, and infiltration (maximum score 3 each) are summed to obtain the Total Clinical Score.
Outcome measures
| Measure |
Daivobet® Gel Applied Then Removed After 10 Minutes
n=24 Participants
Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
Daivobet® Gel Applied Then Removed After 20 Minutes
n=24 Participants
\- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
Daivobet® Gel Applied for 24 Hours
n=24 Participants
\- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
Daivobet® Gel Vehicle Applied for 24 Hours
n=24 Participants
Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
|---|---|---|---|---|
|
Change in Total Clinical Score at Day 18 Compared to Baseline
|
-3.4 units on a scale
Standard Deviation 1.5
|
-3.4 units on a scale
Standard Deviation 1.6
|
-4.3 units on a scale
Standard Deviation 1.5
|
-1.1 units on a scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Baseline to day 4Investigator's rating of the clinical appearance of erythema. Maximum score is 3 (most severe); minimum score is 0 (absent).
Outcome measures
| Measure |
Daivobet® Gel Applied Then Removed After 10 Minutes
n=24 Participants
Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
Daivobet® Gel Applied Then Removed After 20 Minutes
n=24 Participants
\- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
Daivobet® Gel Applied for 24 Hours
n=24 Participants
\- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
Daivobet® Gel Vehicle Applied for 24 Hours
n=24 Participants
Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
|---|---|---|---|---|
|
Change From Baseline in Erythema at Day 4.
|
-0.17 units on a scale
Standard Deviation 0.32
|
-0.23 units on a scale
Standard Deviation 0.36
|
-0.23 units on a scale
Standard Deviation 0.36
|
-0.06 units on a scale
Standard Deviation 0.22
|
SECONDARY outcome
Timeframe: Baseline to day 8Investigator's rating of the clinical appearance of erythema. Maximum score is 3 (most severe); minimum score is 0 (absent).
Outcome measures
| Measure |
Daivobet® Gel Applied Then Removed After 10 Minutes
n=24 Participants
Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
Daivobet® Gel Applied Then Removed After 20 Minutes
n=24 Participants
\- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
Daivobet® Gel Applied for 24 Hours
n=24 Participants
\- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
Daivobet® Gel Vehicle Applied for 24 Hours
n=24 Participants
Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
|---|---|---|---|---|
|
Change From Baseline in Erythema at Day 8.
|
-0.54 units on a scale
Standard Deviation 0.51
|
-0.56 units on a scale
Standard Deviation 0.50
|
-0.67 units on a scale
Standard Deviation 0.55
|
-0.15 units on a scale
Standard Deviation 0.35
|
SECONDARY outcome
Timeframe: Baseline to day 11Investigator's rating of the clinical appearance of erythema. Maximum score is 3 (most severe); minimum score is 0 (absent).
Outcome measures
| Measure |
Daivobet® Gel Applied Then Removed After 10 Minutes
n=24 Participants
Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
Daivobet® Gel Applied Then Removed After 20 Minutes
n=24 Participants
\- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
Daivobet® Gel Applied for 24 Hours
n=24 Participants
\- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
Daivobet® Gel Vehicle Applied for 24 Hours
n=24 Participants
Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
|---|---|---|---|---|
|
Change From Baseline in Erythema at Day 11
|
-0.79 units on a scale
Standard Deviation 0.57
|
-0.85 units on a scale
Standard Deviation 0.52
|
-1.06 units on a scale
Standard Deviation 0.58
|
-0.27 units on a scale
Standard Deviation 0.36
|
SECONDARY outcome
Timeframe: Baseline to day 15Investigator's rating of the clinical appearance of erythema. Maximum score is 3 (most severe); minimum score is 0 (absent).
Outcome measures
| Measure |
Daivobet® Gel Applied Then Removed After 10 Minutes
n=24 Participants
Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
Daivobet® Gel Applied Then Removed After 20 Minutes
n=24 Participants
\- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
Daivobet® Gel Applied for 24 Hours
n=24 Participants
\- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
Daivobet® Gel Vehicle Applied for 24 Hours
n=24 Participants
Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
|---|---|---|---|---|
|
Change From Baseline in Erythema at Day 15
|
-1.00 units on a scale
Standard Deviation 0.49
|
-1.04 units on a scale
Standard Deviation 0.62
|
-1.29 units on a scale
Standard Deviation 0.57
|
-0.31 units on a scale
Standard Deviation 0.48
|
SECONDARY outcome
Timeframe: Baseline to day 18Investigator's rating of the clinical appearance of erythema. Maximum score is 3 (most severe); minimum score is 0 (absent).
Outcome measures
| Measure |
Daivobet® Gel Applied Then Removed After 10 Minutes
n=24 Participants
Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
Daivobet® Gel Applied Then Removed After 20 Minutes
n=24 Participants
\- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
Daivobet® Gel Applied for 24 Hours
n=24 Participants
\- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
Daivobet® Gel Vehicle Applied for 24 Hours
n=24 Participants
Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
|---|---|---|---|---|
|
Change From Baseline in Erythema at Day 18
|
-1.04 units on a scale
Standard Deviation 0.53
|
-1.19 units on a scale
Standard Deviation 0.53
|
-1.42 units on a scale
Standard Deviation 0.50
|
-0.46 units on a scale
Standard Deviation 0.41
|
SECONDARY outcome
Timeframe: Baseline to day 22Investigator's rating of the clinical appearance of erythema. Maximum score is 3 (most severe); minimum score is 0 (absent).
Outcome measures
| Measure |
Daivobet® Gel Applied Then Removed After 10 Minutes
n=24 Participants
Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
Daivobet® Gel Applied Then Removed After 20 Minutes
n=24 Participants
\- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
Daivobet® Gel Applied for 24 Hours
n=24 Participants
\- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
Daivobet® Gel Vehicle Applied for 24 Hours
n=24 Participants
Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
|---|---|---|---|---|
|
Change From Baseline in Erythema at Day 22
|
-1.17 units on a scale
Standard Deviation 0.60
|
-1.31 units on a scale
Standard Deviation 0.66
|
-1.56 units on a scale
Standard Deviation 0.61
|
-0.42 units on a scale
Standard Deviation 0.41
|
SECONDARY outcome
Timeframe: Baseline to day 4Investigator's rating of the clinical appearance of infiltration. Maximum score is 3 (most severe); minimum score is 0 (absent).
Outcome measures
| Measure |
Daivobet® Gel Applied Then Removed After 10 Minutes
n=24 Participants
Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
Daivobet® Gel Applied Then Removed After 20 Minutes
n=24 Participants
\- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
Daivobet® Gel Applied for 24 Hours
n=24 Participants
\- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
Daivobet® Gel Vehicle Applied for 24 Hours
n=24 Participants
Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
|---|---|---|---|---|
|
Change From Baseline in Infiltration at Day 4
|
-0.10 units on a scale
Standard Deviation 0.29
|
-0.08 units on a scale
Standard Deviation 0.28
|
-0.10 units on a scale
Standard Deviation 0.25
|
0.02 units on a scale
Standard Deviation 0.10
|
SECONDARY outcome
Timeframe: Baseline to day 8Investigator's rating of the clinical appearance of infiltration. Maximum score is 3 (most severe); minimum score is 0 (absent).
Outcome measures
| Measure |
Daivobet® Gel Applied Then Removed After 10 Minutes
n=24 Participants
Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
Daivobet® Gel Applied Then Removed After 20 Minutes
n=24 Participants
\- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
Daivobet® Gel Applied for 24 Hours
n=24 Participants
\- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
Daivobet® Gel Vehicle Applied for 24 Hours
n=24 Participants
Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
|---|---|---|---|---|
|
Change From Baseline in Infiltration at Day 8
|
-0.33 units on a scale
Standard Deviation 0.38
|
-0.33 units on a scale
Standard Deviation 0.50
|
-0.38 units on a scale
Standard Deviation 0.47
|
0.00 units on a scale
Standard Deviation 0.26
|
SECONDARY outcome
Timeframe: Baseline to day 11Investigator's rating of the clinical appearance of infiltration. Maximum score is 3 (most severe); minimum score is 0 (absent).
Outcome measures
| Measure |
Daivobet® Gel Applied Then Removed After 10 Minutes
n=2 Participants
Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
Daivobet® Gel Applied Then Removed After 20 Minutes
n=24 Participants
\- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
Daivobet® Gel Applied for 24 Hours
n=24 Participants
\- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
Daivobet® Gel Vehicle Applied for 24 Hours
n=24 Participants
Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
|---|---|---|---|---|
|
Change From Baseline in Infiltration at Day 11
|
-0.63 units on a scale
Standard Deviation 0.52
|
-0.60 units on a scale
Standard Deviation 0.59
|
-0.81 units on a scale
Standard Deviation 0.53
|
-0.08 units on a scale
Standard Deviation 0.32
|
SECONDARY outcome
Timeframe: Baseline to day 15Investigator's rating of the clinical appearance of infiltration. Maximum score is 3 (most severe); minimum score is 0 (absent).
Outcome measures
| Measure |
Daivobet® Gel Applied Then Removed After 10 Minutes
n=24 Participants
Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
Daivobet® Gel Applied Then Removed After 20 Minutes
n=24 Participants
\- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
Daivobet® Gel Applied for 24 Hours
n=24 Participants
\- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
Daivobet® Gel Vehicle Applied for 24 Hours
n=24 Participants
Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
|---|---|---|---|---|
|
Change From Baseline in Infiltration at Day 15
|
-0.81 units on a scale
Standard Deviation 0.55
|
-0.73 units on a scale
Standard Deviation 0.63
|
-1.19 units on a scale
Standard Deviation 0.62
|
-0.15 units on a scale
Standard Deviation 0.28
|
SECONDARY outcome
Timeframe: Baseline to day 18Investigator's rating of the clinical appearance of infiltration. Maximum score is 3 (most severe); minimum score is 0 (absent).
Outcome measures
| Measure |
Daivobet® Gel Applied Then Removed After 10 Minutes
n=24 Participants
Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
Daivobet® Gel Applied Then Removed After 20 Minutes
n=24 Participants
\- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
Daivobet® Gel Applied for 24 Hours
n=24 Participants
\- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
Daivobet® Gel Vehicle Applied for 24 Hours
n=24 Participants
Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
|---|---|---|---|---|
|
Change From Baseline in Infiltration at Day 18
|
-1.00 units on a scale
Standard Deviation 0.59
|
-0.98 units on a scale
Standard Deviation 0.70
|
-1.42 units on a scale
Standard Deviation 0.65
|
-0.17 units on a scale
Standard Deviation 0.32
|
SECONDARY outcome
Timeframe: Baseline to day 22Investigator's rating of the clinical appearance of infiltration. Maximum score is 3 (most severe); minimum score is 0 (absent).
Outcome measures
| Measure |
Daivobet® Gel Applied Then Removed After 10 Minutes
n=24 Participants
Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
Daivobet® Gel Applied Then Removed After 20 Minutes
n=24 Participants
\- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
Daivobet® Gel Applied for 24 Hours
n=24 Participants
\- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
Daivobet® Gel Vehicle Applied for 24 Hours
n=24 Participants
Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
|---|---|---|---|---|
|
Change From Baseline in Infiltration at Day 22
|
-1.08 units on a scale
Standard Deviation 0.60
|
-1.06 units on a scale
Standard Deviation 0.74
|
-1.60 units on a scale
Standard Deviation 0.61
|
-0.31 units on a scale
Standard Deviation 0.32
|
SECONDARY outcome
Timeframe: Baseline to day 4Investigator's rating of the clinical appearance of scaling. Maximum score is 3 (most severe); minimum score is 0 (absent).
Outcome measures
| Measure |
Daivobet® Gel Applied Then Removed After 10 Minutes
n=24 Participants
Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
Daivobet® Gel Applied Then Removed After 20 Minutes
n=24 Participants
\- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
Daivobet® Gel Applied for 24 Hours
n=24 Participants
\- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
Daivobet® Gel Vehicle Applied for 24 Hours
n=24 Participants
Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
|---|---|---|---|---|
|
Change From Baseline in Scaling at Day 4
|
-0.19 units on a scale
Standard Deviation 0.32
|
-0.19 units on a scale
Standard Deviation 0.29
|
-0.10 units on a scale
Standard Deviation 0.33
|
-0.08 units on a scale
Standard Deviation 0.35
|
SECONDARY outcome
Timeframe: Baseline to day 8Investigator's rating of the clinical appearance of scaling. Maximum score is 3 (most severe); minimum score is 0 (absent).
Outcome measures
| Measure |
Daivobet® Gel Applied Then Removed After 10 Minutes
n=24 Participants
Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
Daivobet® Gel Applied Then Removed After 20 Minutes
n=24 Participants
\- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
Daivobet® Gel Applied for 24 Hours
n=24 Participants
\- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
Daivobet® Gel Vehicle Applied for 24 Hours
n=24 Participants
Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
|---|---|---|---|---|
|
Change From Baseline in Scaling at Day 8
|
-0.60 units on a scale
Standard Deviation 0.55
|
-0.46 units on a scale
Standard Deviation 0.57
|
-0.56 units on a scale
Standard Deviation 0.52
|
-0.06 units on a scale
Standard Deviation 0.45
|
SECONDARY outcome
Timeframe: Baseline to day 11Investigator's rating of the clinical appearance of scaling. Maximum score is 3 (most severe); minimum score is 0 (absent).
Outcome measures
| Measure |
Daivobet® Gel Applied Then Removed After 10 Minutes
n=24 Participants
Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
Daivobet® Gel Applied Then Removed After 20 Minutes
n=24 Participants
\- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
Daivobet® Gel Applied for 24 Hours
n=24 Participants
\- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
Daivobet® Gel Vehicle Applied for 24 Hours
n=24 Participants
Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
|---|---|---|---|---|
|
Change From Baseline in Scaling at Day 11
|
-0.90 units on a scale
Standard Deviation 0.57
|
-0.88 units on a scale
Standard Deviation 0.45
|
-1.08 units on a scale
Standard Deviation 0.58
|
-0.35 units on a scale
Standard Deviation 0.50
|
SECONDARY outcome
Timeframe: Baseline to day 15Investigator's rating of the clinical appearance of scaling. Maximum score is 3 (most severe); minimum score is 0 (absent).
Outcome measures
| Measure |
Daivobet® Gel Applied Then Removed After 10 Minutes
n=24 Participants
Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
Daivobet® Gel Applied Then Removed After 20 Minutes
n=24 Participants
\- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
Daivobet® Gel Applied for 24 Hours
n=24 Participants
\- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
Daivobet® Gel Vehicle Applied for 24 Hours
n=24 Participants
Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
|---|---|---|---|---|
|
Change From Baseline in Scaling at Day 15
|
-1.15 units on a scale
Standard Deviation 0.54
|
-1.04 units on a scale
Standard Deviation 0.55
|
-1.40 units on a scale
Standard Deviation 0.53
|
-0.42 units on a scale
Standard Deviation 0.55
|
SECONDARY outcome
Timeframe: Baseline to day 18Investigator's rating of the clinical appearance of scaling. Maximum score is 3 (most severe); minimum score is 0 (absent).
Outcome measures
| Measure |
Daivobet® Gel Applied Then Removed After 10 Minutes
n=24 Participants
Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
Daivobet® Gel Applied Then Removed After 20 Minutes
n=24 Participants
\- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
Daivobet® Gel Applied for 24 Hours
n=24 Participants
\- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
Daivobet® Gel Vehicle Applied for 24 Hours
n=24 Participants
Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
|---|---|---|---|---|
|
Change From Baseline in Scaling at Day 18
|
-1.35 units on a scale
Standard Deviation 0.56
|
-1.27 units on a scale
Standard Deviation 0.61
|
-1.50 units on a scale
Standard Deviation 0.63
|
-0.48 units on a scale
Standard Deviation 0.45
|
SECONDARY outcome
Timeframe: Baseline to day 22Investigator's rating of the clinical appearance of scaling. Maximum score is 3 (most severe); minimum score is 0 (absent).
Outcome measures
| Measure |
Daivobet® Gel Applied Then Removed After 10 Minutes
n=24 Participants
Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
Daivobet® Gel Applied Then Removed After 20 Minutes
n=24 Participants
\- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
Daivobet® Gel Applied for 24 Hours
n=24 Participants
\- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
Daivobet® Gel Vehicle Applied for 24 Hours
n=24 Participants
Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
|---|---|---|---|---|
|
Change From Baseline in Scaling at Day 22
|
-1.31 units on a scale
Standard Deviation 0.60
|
-1.31 units on a scale
Standard Deviation 0.70
|
-1.71 units on a scale
Standard Deviation 0.53
|
-0.54 units on a scale
Standard Deviation 0.41
|
SECONDARY outcome
Timeframe: Baseline to day 22Outcome measures
| Measure |
Daivobet® Gel Applied Then Removed After 10 Minutes
n=24 Participants
Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
Daivobet® Gel Applied Then Removed After 20 Minutes
n=24 Participants
\- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
Daivobet® Gel Applied for 24 Hours
n=24 Participants
\- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
Daivobet® Gel Vehicle Applied for 24 Hours
n=24 Participants
Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
|---|---|---|---|---|
|
Change in Lesion Thickness Measured by Ultrasound From Baseline to Day 22.
|
-0.61 millimeters
Standard Deviation 0.47
|
-0.80 millimeters
Standard Deviation 0.57
|
-0.90 millimeters
Standard Deviation 0.51
|
-0.11 millimeters
Standard Deviation 0.26
|
SECONDARY outcome
Timeframe: Baseline to day 22Outcome measures
| Measure |
Daivobet® Gel Applied Then Removed After 10 Minutes
n=24 Participants
Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
Daivobet® Gel Applied Then Removed After 20 Minutes
n=24 Participants
\- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
Daivobet® Gel Applied for 24 Hours
n=24 Participants
\- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
Daivobet® Gel Vehicle Applied for 24 Hours
n=24 Participants
Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
|---|---|---|---|---|
|
Change in Skin Thickness - Echo-poor Band - Measured by Ultrasound From Baseline to Day 22
|
-0.57 millimeters
Standard Deviation 0.35
|
-0.54 millimeters
Standard Deviation 0.50
|
-0.62 millimeters
Standard Deviation 0.33
|
-0.06 millimeters
Standard Deviation 0.30
|
Adverse Events
Daivobet® Gel
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Daivobet® Gel
n=24 participants at risk
Each of the 24 subjects participating in this exploratory trial received:
* Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks
* Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
* Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks
* Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks
The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque.
|
|---|---|
|
Infections and infestations
Nasopharyngititis
|
8.3%
2/24
|
|
Nervous system disorders
Headache
|
8.3%
2/24
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor is entitled to review and comment on publications prior to submission or presentation. Upon request of the sponsor, the investigator shall delay publication or presentation to allow for protection of the sponsors inventions and other intellectual property.
- Publication restrictions are in place
Restriction type: OTHER