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Safety and Efficacy of CD10367 in Psoriasis Vulgaris

Primary Purpose

Psoriasis Vulgaris

Status

Completed

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

CD10367 3% Solution - Non-desquamated zone

CD10367 1% Solution - Non-desquamated zone

CD10367 solution placebo - Non-desquamated zone

Betneval ointment - Non-desquamated zone

CD10367 3% Solution - Desquamated zone

CD10367 solution placebo - Desquamated zone

About this trial

This is an interventional treatment trial for Psoriasis Vulgaris

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Adult male or female aged at least 18 and up to 70 years old inclusive at screening visit.
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).
Subject has a skin phototype I to IV on Fitzpatrick's scale. (Screening visit).
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).
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,
Subject agrees not to wear his/her contact lenses from the Baseline visit till the D19 visit, (Screening visit)

Exclusion Criteria:

The subject presents guttate, erythrodermic, exfoliative, inverse, pustular, palmo plantar, infected or ulcerated psoriasis (Screening visit).
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).
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).
The subject has known history of adverse drug reaction or hypersensitivity to a product with the same mode of action
The subject has any abnormal clinically significant findings according to the ophthalmologist, at the ophthalmological exam at Screening visit,
The subject presents any abnormal laboratory tests judged clinically significant by the investigator (blood samplings and urinalysis done at Screening visit),
The subject has QTc interval >450msec or any abnormal ECG value considered as clinically significant by the cardiologist (Screening visit).
The subject has received, applied or taken some specified treatments within the specified time frame prior to the Baseline visit.

Sites / Locations

Galderma Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Placebo Comparator

Active Comparator

Experimental

Placebo Comparator

Arm Label

CD10367 3% Solution - Non-desquamated zone

CD10367 1% Solution - Non-desquamated zone

CD10367 solution placebo - Non-desquamated zone

Betneval ointment - Non-desquamated zone

CD10367 3% Solution - Desquamated zone

CD10367 solution placebo - Desquamated zone

Arm Description

CD10367 solution placebo serves as negative control.

This comparator containing Betamethasone valerate 0.1% serves as positive control.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

NCT ID

NCT03025282

First Posted

January 17, 2017

Last Updated

April 4, 2017

Sponsor

Galderma R&D

1. Study Identification

Unique Protocol Identification Number

NCT03025282

Brief Title

Safety and Efficacy of CD10367 in Psoriasis Vulgaris

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Completed

Study Start Date

November 3, 2016 (Actual)

Primary Completion Date

March 24, 2017 (Actual)

Study Completion Date

March 24, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Galderma R&D

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriasis Vulgaris

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CD10367 3% Solution - Non-desquamated zone

Arm Type

Experimental

Arm Title

CD10367 1% Solution - Non-desquamated zone

Arm Type

Experimental

Arm Title

CD10367 solution placebo - Non-desquamated zone

Arm Type

Placebo Comparator

Arm Description

CD10367 solution placebo serves as negative control.

Arm Title

Betneval ointment - Non-desquamated zone

Arm Type

Active Comparator

Arm Description

This comparator containing Betamethasone valerate 0.1% serves as positive control.

Arm Title

CD10367 3% Solution - Desquamated zone

Arm Type

Experimental

Arm Title

CD10367 solution placebo - Desquamated zone

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

CD10367 3% Solution - Non-desquamated zone

Intervention Description

Once daily application for 3 weeks

Intervention Type

Drug

Intervention Name(s)

CD10367 1% Solution - Non-desquamated zone

Intervention Description

Once daily application for 3 weeks

Intervention Type

Drug

Intervention Name(s)

CD10367 solution placebo - Non-desquamated zone

Intervention Description

Once daily application for 3 weeks

Intervention Type

Drug

Intervention Name(s)

Betneval ointment - Non-desquamated zone

Other Intervention Name(s)

Betamethasone Valerate

Intervention Description

Once daily application for 3 weeks

Intervention Type

Drug

Intervention Name(s)

CD10367 3% Solution - Desquamated zone

Intervention Description

Once daily application for 3 weeks

Intervention Type

Drug

Intervention Name(s)

CD10367 solution placebo - Desquamated zone

Intervention Description

Once daily application for 3 weeks

Primary Outcome Measure Information:

Title

Area Under the Curve (AUC) of Total Sum Score (sum of erythema, scaling and induration scores) from Baseline to Day 19

Description

Time Frame

Baseline to Day 19

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Adult male or female aged at least 18 and up to 70 years old inclusive at screening visit. 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). Subject has a skin phototype I to IV on Fitzpatrick's scale. (Screening visit). 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). 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, Subject agrees not to wear his/her contact lenses from the Baseline visit till the D19 visit, (Screening visit) Exclusion Criteria: The subject presents guttate, erythrodermic, exfoliative, inverse, pustular, palmo plantar, infected or ulcerated psoriasis (Screening visit). 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). 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). The subject has known history of adverse drug reaction or hypersensitivity to a product with the same mode of action The subject has any abnormal clinically significant findings according to the ophthalmologist, at the ophthalmological exam at Screening visit, The subject presents any abnormal laboratory tests judged clinically significant by the investigator (blood samplings and urinalysis done at Screening visit), The subject has QTc interval >450msec or any abnormal ECG value considered as clinically significant by the cardiologist (Screening visit). The subject has received, applied or taken some specified treatments within the specified time frame prior to the Baseline visit.

Facility Information:

Facility Name

Galderma Investigational Site

City

Nice

Country

France

12. IPD Sharing Statement

Learn more about this trial

Safety and Efficacy of CD10367 in Psoriasis Vulgaris

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