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COMPLETEDPHASE2

A Short-contact Plaque Test Study With Daivobet® Gel in Psoriasis Vulgaris

A Phase IIa Exploratory Study Evaluating the Anti-psoriatic Effect of Daivobet® Gel Applied Then Removed After 10 Minutes, Daivobet® Gel Applied Then Removed After 20 Minutes, Daivobet® Gel Applied for 24 Hours and Daivobet® Gel Vehicle Applied for 24 Hours

NCT01607853•LEO Pharma

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Following verbal and written information about the trial, the subject has to provide signed and dated informed consent before any study related activities are carried out.
•2. Age 18 years or above.
•3. Either sex.
•4. All skin types.
•5. Subjects with a diagnosis of psoriasis vulgaris with lesions located on arms, legs and/or trunk. The lesions must have a total size suitable for application of 4 different products.
•6. Subjects with, in the opinion of the investigator, stable psoriasis based on Total Plaque Score evaluated at screening visit and at visit 2 (baseline).
•7. Subjects with psoriasis lesions (plaques) assessed by a Total Clinical Score (sum of scores of erythema, scaling and infiltration) of 4 to 9 inclusive, but each individual item ≥ 1.
•8. Subjects willing and able to follow all the study procedures and complete the whole study.
•9. Subjects affiliated to a social security system.
•10. Female subjects of childbearing potential using a reliable method of contraception for at least 1 month before the study start and during the course of the study (e.g., oral contraceptive pill, intrauterine device, contraceptive patches, implantable contraception, condoms) or females of non-childbearing potential (i.e. postmenopausal (absence of menstrual bleeding for 2 years), hysterectomy, bilateral ovariectomy or tubal section/ligation).
+1 more criteria

Exclusion Criteria

•1. Females who are pregnant, of child-bearing potential and who wish to become pregnant during the study, or who are breast feeding.
•2. Systemic treatment with biological therapies (marketed or not marketed) with a possible effect on psoriasis vulgaris within 4 weeks (etanercept), 2 months (adalimumab, alefacept, infliximab), 4 months (ustekinumab) or 4 weeks/5 half-lives (which-ever is longer) for experimental biological products prior to randomisation and during the study.
•3. Systemic treatments with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (e.g., corticosteroids, retinoids, immunosuppressants) within the 4- week period prior to randomisation and during the study.
•4. Use of phototherapy within the following time periods prior to randomisation and during the study:
•* PUVA or Grenz ray therapy (4 weeks),
•* UVB (2 weeks).
•5. Subjects using one of the following topical drugs within 4 weeks prior to randomisation and during the study:
•\- Potent or very potent (WHO group III-IV) corticosteroids.
•6. Subjects using one of the following topical drugs for the treatment of psoriasis within 2 weeks prior to randomisation and during the study:
•* WHO group I-II corticosteroids (except if used for treatment of scalp and/or facial psoriasis),
+23 more criteria

Locations (1)

Centre de Pharmacologie Clinique Appliquée à la Dermatologie (CPCAD)

Nice, France

Key Dates

Start Date

June 1, 2012

Primary Completion Date

October 1, 2012

Completion Date

October 1, 2012

Last Updated

March 10, 2025

Enrollment

ACTUAL participants

Conditions

Psoriasis Vulgaris

Interventions

Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes)

DRUG

Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes)

DRUG

Daivobet® gel applied for 24 hours (+/- 2 hours)

DRUG

Daivobet® gel vehicle applied for 24 hours (+/- 2 hours)

DRUG

Therapeutic Drug Monitoring of Brodalumab in Psoriasis Patients (BIOLOPTIM-BRO)

NCT04080635

Psoriasis Vulgaris

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COMPLETEDPHASE4

Dose Reduction of IL17 and IL23 Inhibitors in Psoriasis

NCT04340076

PsoriasisPsoriasis Vulgaris

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WITHDRAWNNA

Safety and Effectiveness of Combined LED Light for the Treatment of Mild to Moderate Plaque Type Psoriasis Vulgaris

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 10, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Short-contact Plaque Test Study With Daivobet® Gel in Psoriasis Vulgaris

Inclusion Criteria

Exclusion Criteria

Therapeutic Drug Monitoring of Brodalumab in Psoriasis Patients (BIOLOPTIM-BRO)

Dose Reduction of IL17 and IL23 Inhibitors in Psoriasis

Safety and Effectiveness of Combined LED Light for the Treatment of Mild to Moderate Plaque Type Psoriasis Vulgaris

Special Drug Use-results Survey to Evaluate Safety and Efficacy of Cosentyx in Pediatric Patients With PsV, PsA, or GPP

A Pilot Study to Explore the Role of Gut Flora in Psoriasis

The Mediterranean Diet and Time-Restricted Eating Dietary Interventions for Psoriasis Study