Safety and Efficacy of CD10367 in Psoriasis Vulgaris

• Status: Completed
• Trial end date: 2017-03-24
• Target enrollment: 0
• Participant gender: All

Summary

This is an exploratory, single-centre, investigator blinded, randomized, controlled, intra-individual study, involving subjects with psoriasis vulgaris.

The objective is to evaluate, in a modified Dumas-Scholtz psoriasis mini-zone test, the safety and efficacy of CD10367 solution at 1% and 3% after a 3-week treatment period of once daily application.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Galderma R&D
• Treatments: Betamethasone; Betamethasone benzoate; Betamethasone sodium phosphate; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

1. Adult male or female aged at least 18 and up to 70 years old inclusive at screening visit.

2. Female of non childbearing potential (postmenopausal [absence of menstrual bleeding for 1 year prior to screening, without any other medical reason], hysterectomy or bilateral oophorectomy).

3. Subject has a skin phototype I to IV on Fitzpatrick's scale. (Screening visit).

4. The subject has a clinical diagnosis of stable plaque psoriasis, defined as no flare during the month before Screening visit and no change between Screening visit and Baseline visit, of mild to moderate severity. (Screening visit and Baseline Visit).

5. The subject presents with at least six eligible mini-zones, on at least two psoriasis plaques (Screening visit and verified also at Baseline Visit) with specific severity grades,

6. Subject agrees not to wear his/her contact lenses from the Baseline visit till the D19 visit, (Screening visit)

Exclusion Criteria:

1. The subject presents guttate, erythrodermic, exfoliative, inverse, pustular, palmo plantar, infected or ulcerated psoriasis (Screening visit).

2. The subject has any uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with the interpretation of the clinical trial results, and/or put the subject at significant risk (according to Investigator's judgment) if he/she participates in the clinical trial (e.g. history of on-going gastric or duodenal ulcer, clinically significant lung disease, etc.) (Screening visit).

3. The subject has known or suspected allergies or sensitivities to any components of the study drugs or of the keratolytic product (see Investigator's Brochure/Product label). (Screening visit).

4. The subject has known history of adverse drug reaction or hypersensitivity to a product with the same mode of action

5. The subject has any abnormal clinically significant findings according to the ophthalmologist, at the ophthalmological exam at Screening visit,

6. The subject presents any abnormal laboratory tests judged clinically significant by the investigator (blood samplings and urinalysis done at Screening visit),

7. The subject has QTc interval >450msec or any abnormal ECG value considered as clinically significant by the cardiologist (Screening visit).

8. The subject has received, applied or taken some specified treatments within the specified time frame prior to the Baseline visit.