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

A Plaque Test Comparing 4 Steroids With Daivobet® Ointment and a Vehicle Control for the Treatment of Psoriasis Vulgaris

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00845481

Enrollment

Registered

2009-02-18

Start date

2009-01-31

Completion date

2009-05-31

Last updated

2025-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis Vulgaris

Brief summary

The purpose of the study is to compare the anti-psoriatic effect of marketed products with Daivobet® ointment in a plaque test

Interventions

DRUGDaivobet® ointment

Once daily application 6 days a week for 3 weeks

DRUGBetnovat® ointment

Once daily application 6 days a week for 3 weeks

DRUGDiprosalic ointment

Once daily application 6 days a week for 3 weeks

DRUGDermovat ointment

Once daily application 6 days a week for 3 weeks

DRUGElocon ointment

Once daily application 6 days a week for 3 weeks

DRUGDaivobet® ointment vehicle

Once daily application 6 days a week for 3 weeks

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

(in summary) * Subjects having understood and signed an informed consent form * All skin types * Subjects with a diagnosis of psoriasis vulgaris with lesions located on arms, legs or trunk. The lesions must have a total size suitable for application. The subjects should be asked if their lesions have been stable * Subjects willing and able to follow all the study procedures and complete the whole study * Subjects affiliated to social security system

Exclusion criteria

(in summary) * Females who are pregnant, of child-bearing potential and who wish to become pregnant during the study, or who are breast feeding * Subjects using biological therapies (marketed or not marketed) with a possible effect on psoriasis (e.g. alefacept, efalizumab, etanercept, infliximab, adalimumab) within 12 weeks prior to study drug administration * Systemic treatments with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (e.g., corticosteroids, vitamin D-analogues, retinoids, immunosuppressants) within the 4-week period prior to randomisation * Subjects using one of the following topical drugs for the treatment of psoriasis within four (4) weeks prior to study drug administration: - Potent or very potent (WHO group III-IV) corticosteroids - PUVA or Grenz ray therapy * Subjects using one of the following topical drugs for the treatment of psoriasis within two (2) weeks prior to study drug administration: - WHO group I-II corticosteroids - Topical retinoids - Vitamin D-analogues - Topical immunomodulators (e.g. macrolides) - Anthracen derivatives - Tar - Salicylic acid - UVB therapy * Subjects with skin manifestations in relation to syphilis or tuberculosis, rosacea, perioral dermatitis, acne vulgaris, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, acne rosacea, ulcers and wounds within the plaque test areas

Design outcomes

Primary

Measure	Time frame	Description
The Absolute Change in Total Clinical Score (TCS) at End of Treatment Compared to Baseline for Daivobet® Ointment	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)
The Absolute Change in Total Clinical Score (TCS) at End of Treatment Compared to Baseline for Betnovat® Ointment	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)
The Absolute Change in Total Clinical Score (TCS) at End of Treatment Compared to Baseline for Elocon Ointment	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)
The Absolute Change in Total Clinical Score (TCS) at End of Treatment Compared to Baseline for Daivobet Ointment Vehicle	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)
The Absolute Change in Total Clinical Score (TCS) at End of Treatment Compared to Baseline for Dermovat Ointment	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)
The Absolute Change in Total Clinical Score (TCS) at End of Treatment Compared to Baseline for Diprosalic Ointment	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)

Countries

France

Participant flow

Participants by arm

Arm	Count
Patients Treated Treatments are given at the same time on different locations of the skin with psoriasis in the same group of participants.	24
Total	24

Baseline characteristics

Characteristic	Patients Treated
Age, Continuous	50.5 years STANDARD_DEVIATION 9.6
Age, Customized <=18 years	0 participants
Age, Customized >=68 years	1 participants
Age, Customized Between 18 and 67 years	23 participants
Region of Enrollment France	24 participants
Sex: Female, Male Female	8 Participants
Sex: Female, Male Male	16 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	0 / 24
serious Total, serious adverse events	0 / 24