STUDY OF THE EFFICACY AND SAFETY OF A PAD™ CALCIPOTRIOL CREAM IN THE PSORIASIS PLAQUE TEST

Phase 1

• Conditions: Psoriasis vulgaris; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2015-003893-34-FR
• Lead Sponsor: Drug Delivery Solutions Aps (DDS) c/o MC2 Biotek Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-03-16
• Study Completion: 2016-09-27
• Last Update Posted: 3 May 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1.Male or female subjects aged 18 years or above having signed and dated an informed consent,
2.Female subject of non-child bearing potential, defined as surgically sterile or post-menopausal (at least one year post cessation of menses),
3.Female of childbearing potential who has been, in the opinion of the Investigator, using an approved method of birth control (e.g. oral contraception pill or patch, intra-uterine devices, contraceptive implants or vaginal rings, condoms) for at least 1 month prior to Screening visit. Subject having a negative urine pregnancy test at screening and agreeing to continue adequate contraception during the entire study period and 1 month after the end of the study,
4.Subjects with a diagnosis of psoriasis vulgaris with lesions located on arms and/or legs and/or trunk. The subjects should have one or more plaques for the application of the six (6) products,
5.Subjects with, in the opinion of the investigator, stable psoriasis based on Total Plaque Score evaluated at screening visit and at baseline visit,
6.Subjects with psoriasis lesions (plaques) which must have a sum of scores of erythema, scaling and infiltration = 5 and each individual item must be = 1,

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 24
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 24

Exclusion Criteria

1.Subjects with current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis,
2.Female subjects who are pregnant or who are breast feeding,
3.Subjects with systemic treatment with biological therapies (marketed or not marketed) with a possible effect on psoriasis vulgaris within 4 months prior to randomisation and during the study,
4.Subjects with any systemic treatments, with a potential effect on psoriasis vulgaris (e.g., corticosteroids, retinoids, immunosuppressants) within the 4-week period prior to randomisation and during the study.
5.Subjects using any potent or very potent (WHO group III-IV) topical corticosteroids within the 4 week period prior to randomisation,
6.Subjects using of phototherapy within 4 weeks prior to randomisation:
7.Subjects using topical drugs for the treatment of psoriasis within two weeks prior to randomisation such as:
-Topical retinoids (e.g. tazarotene),
-Topical vitamin D analogues (e.g. calcipotriol),
-Topical immunomodulators (e.g. macrolides),
-WHO group I-II corticosteroids (except on facial psoriasis),
8.Subjects using emollients on the selected plaques within one week before randomisation and during the study,
9.Subjects with initiation of, or expected changes to concomitant medication that may affect psoriasis vulgaris (e.g., beta blockers, anti-malaria drugs, lithium and ACE inhibitors) within 2 weeks prior to randomisation and during the study,

Study & Design

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