Clincal study to compare the therapeutic effects of two ointments with active substances betamethasone dipropionate and salicylic acid and of one ointment without active substance for patients with chronic stable plaque psoriasis

Phase 1

• Conditions: Chronic stable plaque psoriasis; MedDRA version: 20.0Level: LLTClassification code 10050576Term: Psoriasis vulgarisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2020-004081-19-DE
• Lead Sponsor: Dermapharm AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-13
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 306

Inclusion Criteria

- Women and men = 18 years of age
- Written consent to study participation after patient information by the investigator
- Clinical diagnosis of chronic stable (at least 6 months) plaque psoriasis amenable to topical treatment and involving arms and/or legs and/or trunk
- Psoriasis affecting = 10% of the total body surface area (BSA)
- A modified PASI score of = 5 to = 15 at baseline
- For women of childbearing potential: Application of an efficient contraceptive method during the whole study
- For women of childbearing potential: Pregnancy test with negative result prior to study start
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative or pustular psoriasis
• Systemic therapy of psoriasis within the last 4 weeks before study inclusion and during the study
• Use of topical anti-psoriatic therapy (including topical retinoids, topical corticosteroids, vitamin D analogues, salicylic acid, dithranol, coal tar) within two weeks prior study inclusion
• Known intolerance or hypersensitivity against salicylic acid, betamethasone dipropionate or other glucocorticoids or any of the other ingredients in the study medication
• History of psoriasis unresponsive to topical treatment
• Current or past history of renal insufficiency or severe hepatic disorders
• Presence of any of the following skin conditions in the treatment area: viral infections (e.g. herpes simplex, herpes zoster, varicella), fungal and bacterial skin infections, parasitic infections, skin manifestations in relation to tuberculosis, perioral dermatitis, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, acne vulgaris, acne rosacea, rosacea, ulcers, wounds and vaccination reactions
• Other inflammatory skin disease in the treatment area that may confound the evaluation of the stable plaque psoriasis (e.g. atopic dermatitis, contact dermatitis, tinea corporis)
• Presence of pigmentation, extensive scarring, pigmented lesions or sunburn in the treatment area, which could interfere with the rating of efficacy and safety parameters
• Other severe acute or chronic concomitant disease with severe impairment of the general condition
• Other concomitant diseases which may - taking the present knowledge into account - influence the parameters evaluated in the study in a way that an objective evaluation would be impossible
• Other concomitant medication which may - taking the present knowledge into account - influence the methods of measurement used in this study or the resulting data
• Reasonable doubt concerning the co-operation of the patient
• Participation in another clinical study within the last 30 days prior to inclusion in this study
• Participation in this study at an earlier date
• Women with existing or intended pregnancy or during lactation

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified