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

NCT01607853 | Completed Phase 2 Results

• 2 other identifiers: LP0076-572012-001507-21
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Psoriasis Vulgaris

Outcome Measures

Primary Outcomes (1)

• 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

  baseline to day 22

Secondary Outcomes (25)

• Change in Total Clinical Score at Day 4 Compared to Baseline

  Baseline to day 4

• Change in Total Clinical Score at Day 8 Compared to Baseline

  Baseline to day 8

• Change in Total Clinical Score at Day 11 Compared to Baseline

  Baseline to day 11

• Change in Total Clinical Score at Day 15 Compared to Baseline

  Baseline to day 15

• Change in Total Clinical Score at Day 18 Compared to Baseline

  Baseline to day 18

Study Arms (1)

Daivobet® gel

EXPERIMENTAL

Drug: 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)

Interventions

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

Once daily application, 3 weeks

Daivobet® gel

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

Once daily application, 3 weeks

Daivobet® gel

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

Once daily application, 3 weeks

Daivobet® gel

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

Once daily application, 3 weeks

Daivobet® gel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Age 18 years or above.
• Either sex.
• All skin types.
• 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.
• Subjects with, in the opinion of the investigator, stable psoriasis based on Total Plaque Score evaluated at screening visit and at visit 2 (baseline).
• 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.
• Subjects willing and able to follow all the study procedures and complete the whole study.
• Subjects affiliated to a social security system.
• 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).
• Female with a negative urine pregnancy test (at screening visit).

You may not qualify if:

• Females who are pregnant, of child-bearing potential and who wish to become pregnant during the study, or who are breast feeding.
• 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.
• 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.
• 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).
• 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.
• 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),
• Topical retinoids,
• Vitamin D analogues,
• Topical immunomodulators (e.g. calcineurin inhibitors),
• Anthracen derivatives,
• Tar,

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (1)

Centre de Pharmacologie Clinique Appliquée à la Dermatologie (CPCAD)

Nice, 06202, France

Location

Related Links

• Clinical Trials at LEO Pharma

Limitations and Caveats

In this small exploratory trial the subjects received all 4 investigational products on small dermal test sites. Regarding Adverse Events, only local dermal reactions could be potentially attributed to a specific investigational product.

Results Point of Contact

• Title: Clinical Trial Disclosure Manager
• Organization: Leo Pharma A/S

ctr.disclosure@leo-pharma.com

00 45 44 94 58 88

Study Officials

• Catherine Queille-Roussel, MD

  Centre de Pharmacologie Clinique Appliquée à la Dermatologie (CPCAD), Hôpital l'Archet 2, 151 route Saint-Antoine de Ginestière 06202 Nice Cedex 3, France

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2012
• First Posted: May 30, 2012
• Study Start: June 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: March 10, 2025
• Results First Posted: December 24, 2013

Record last verified: 2015-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)