Safety and Efficacy of CD10367 in Psoriasis Vulgaris

Exploratory Study to Evaluate the Safety and Efficacy of CD10367 in Subjects With Psoriasis

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.

Study Overview

• Status: Completed
• Conditions: Psoriasis Vulgaris
• Intervention / Treatment: Drug: CD10367 3% Solution - Non-desquamated zone; Drug: CD10367 1% Solution - Non-desquamated zone; Drug: CD10367 solution placebo - Non-desquamated zone; Drug: Betneval ointment - Non-desquamated zone; Drug: CD10367 3% Solution - Desquamated zone; Drug: CD10367 solution placebo - Desquamated zone

Detailed Description

Study drugs will be applied in each subject once daily, 5 days a week during the first 2 weeks and for 4 days the third week on 6 mini-zones located on at least 2 psoriatic plaques as described below:

• on 2 mini-zones pretreated by a keratolytic product, will be tested:

  • CD10367 3% solution
  • CD10367 solution placebo

• on 4 mini-zones non-pretreated, will be tested:

  • CD10367 3% solution
  • CD10367 1% solution
  • CD10367 solution placebo
  • Betneval 0.1% ointment

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Nice, France
    • Galderma Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CD10367 3% Solution - Non-desquamated zone	Drug: CD10367 3% Solution - Non-desquamated zone; Once daily application for 3 weeks
Experimental: CD10367 1% Solution - Non-desquamated zone	Drug: CD10367 1% Solution - Non-desquamated zone; Once daily application for 3 weeks
Placebo Comparator: CD10367 solution placebo - Non-desquamated zone; CD10367 solution placebo serves as negative control.	Drug: CD10367 solution placebo - Non-desquamated zone; Once daily application for 3 weeks
Active Comparator: Betneval ointment - Non-desquamated zone; This comparator containing Betamethasone valerate 0.1% serves as positive control.	Drug: Betneval ointment - Non-desquamated zone; Once daily application for 3 weeks; Other Names: Betamethasone Valerate
Experimental: CD10367 3% Solution - Desquamated zone	Drug: CD10367 3% Solution - Desquamated zone; Once daily application for 3 weeks
Placebo Comparator: CD10367 solution placebo - Desquamated zone	Drug: CD10367 solution placebo - Desquamated zone; Once daily application for 3 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Curve (AUC) of Total Sum Score (sum of erythema, scaling and induration scores) from Baseline to Day 19	Investigator's rating of the clinical appearance of each psoriatic mini-zone. The single items erythema, scaling, and induration (maximum score 4 each) are summed to obtain the Total Sum Score. Maximum score is 12 (very severe); minimum score is 0 (None).	Baseline to Day 19

Collaborators and Investigators

• Sponsor: Galderma R&D

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2016
• Primary Completion (Actual): March 24, 2017
• Study Completion (Actual): March 24, 2017

Study Registration Dates

• First Submitted: January 17, 2017
• First Submitted That Met QC Criteria: January 17, 2017
• First Posted (Estimate): January 19, 2017

Study Record Updates

• Last Update Posted (Actual): April 5, 2017
• Last Update Submitted That Met QC Criteria: April 4, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Asthmatic Agents; Respiratory System Agents; Betamethasone; Betamethasone Valerate; Pharmaceutical Solutions
• Other Study ID Numbers: RD.03.SPR.112075