The purpose of this study is to evaluate the anti-psoriatic effect of Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes), Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) compared with Daivobet® gel and Daivobet® gel vehicle applied for 24 hours (+/- 2 hours), using the psoriasis plaque test modified from the method developed by KJ Dumas and JR Scholtz.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
24
Once daily application, 3 weeks
Once daily application, 3 weeks
Once daily application, 3 weeks
Centre de Pharmacologie Clinique Appliquée à la Dermatologie (CPCAD)
Nice, France
Change in Total Clinical Score From Baseline to Day 22
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
Time frame: baseline to day 22
Change in Total Clinical Score at Day 4 Compared to Baseline
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 Clinical Score.
Time frame: Baseline to day 4
Change in Total Clinical Score at Day 8 Compared to Baseline
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 Clinical Score.
Time frame: Baseline to day 8
Change in Total Clinical Score at Day 11 Compared to Baseline
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 Clinical Score.
Time frame: Baseline to day 11
Change in Total Clinical Score at Day 15 Compared to Baseline
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 Clinial Score.
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Once daily application, 3 weeks
Time frame: Baseline to day 15
Change in Total Clinical Score at Day 18 Compared to Baseline
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 Clinical Score.
Time frame: Baseline to day 18
Change From Baseline in Erythema at Day 4.
Investigator's rating of the clinical appearance of erythema. Maximum score is 3 (most severe); minimum score is 0 (absent).
Time frame: Baseline to day 4
Change From Baseline in Erythema at Day 8.
Investigator's rating of the clinical appearance of erythema. Maximum score is 3 (most severe); minimum score is 0 (absent).
Time frame: Baseline to day 8
Change From Baseline in Erythema at Day 11
Investigator's rating of the clinical appearance of erythema. Maximum score is 3 (most severe); minimum score is 0 (absent).
Time frame: Baseline to day 11
Change From Baseline in Erythema at Day 15
Investigator's rating of the clinical appearance of erythema. Maximum score is 3 (most severe); minimum score is 0 (absent).
Time frame: Baseline to day 15
Change From Baseline in Erythema at Day 18
Investigator's rating of the clinical appearance of erythema. Maximum score is 3 (most severe); minimum score is 0 (absent).
Time frame: Baseline to day 18
Change From Baseline in Erythema at Day 22
Investigator's rating of the clinical appearance of erythema. Maximum score is 3 (most severe); minimum score is 0 (absent).
Time frame: Baseline to day 22
Change From Baseline in Infiltration at Day 4
Investigator's rating of the clinical appearance of infiltration. Maximum score is 3 (most severe); minimum score is 0 (absent).
Time frame: Baseline to day 4
Change From Baseline in Infiltration at Day 8
Investigator's rating of the clinical appearance of infiltration. Maximum score is 3 (most severe); minimum score is 0 (absent).
Time frame: Baseline to day 8
Change From Baseline in Infiltration at Day 11
Investigator's rating of the clinical appearance of infiltration. Maximum score is 3 (most severe); minimum score is 0 (absent).
Time frame: Baseline to day 11
Change From Baseline in Infiltration at Day 15
Investigator's rating of the clinical appearance of infiltration. Maximum score is 3 (most severe); minimum score is 0 (absent).
Time frame: Baseline to day 15
Change From Baseline in Infiltration at Day 18
Investigator's rating of the clinical appearance of infiltration. Maximum score is 3 (most severe); minimum score is 0 (absent).
Time frame: Baseline to day 18
Change From Baseline in Infiltration at Day 22
Investigator's rating of the clinical appearance of infiltration. Maximum score is 3 (most severe); minimum score is 0 (absent).
Time frame: Baseline to day 22
Change From Baseline in Scaling at Day 4
Investigator's rating of the clinical appearance of scaling. Maximum score is 3 (most severe); minimum score is 0 (absent).
Time frame: Baseline to day 4
Change From Baseline in Scaling at Day 8
Investigator's rating of the clinical appearance of scaling. Maximum score is 3 (most severe); minimum score is 0 (absent).
Time frame: Baseline to day 8
Change From Baseline in Scaling at Day 11
Investigator's rating of the clinical appearance of scaling. Maximum score is 3 (most severe); minimum score is 0 (absent).
Time frame: Baseline to day 11
Change From Baseline in Scaling at Day 15
Investigator's rating of the clinical appearance of scaling. Maximum score is 3 (most severe); minimum score is 0 (absent).
Time frame: Baseline to day 15
Change From Baseline in Scaling at Day 18
Investigator's rating of the clinical appearance of scaling. Maximum score is 3 (most severe); minimum score is 0 (absent).
Time frame: Baseline to day 18
Change From Baseline in Scaling at Day 22
Investigator's rating of the clinical appearance of scaling. Maximum score is 3 (most severe); minimum score is 0 (absent).
Time frame: Baseline to day 22
Change in Lesion Thickness Measured by Ultrasound From Baseline to Day 22.
Time frame: Baseline to day 22
Change in Skin Thickness - Echo-poor Band - Measured by Ultrasound From Baseline to Day 22
Time frame: Baseline to day 22