Safety and Efficacy of CD10367 in Psoriasis Vulgaris

Psoriasis Vulgaris Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03025282
• Other study ID #: RD.03.SPR.112075
• Status: Completed
• Phase: Phase 2
• First received: January 17, 2017
• Last updated: April 4, 2017
• Start date: November 3, 2016
• Est. completion date: March 24, 2017

Study information

• Verified date: April 2017
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 24, 2017
• Est. primary completion date: March 24, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Psoriasis
• Psoriasis Vulgaris

Intervention

Drug:
• CD10367 3% Solution - Non-desquamated zone
Once daily application for 3 weeks
• CD10367 1% Solution - Non-desquamated zone
Once daily application for 3 weeks
• CD10367 solution placebo - Non-desquamated zone
Once daily application for 3 weeks
• Betneval ointment - Non-desquamated zone
Once daily application for 3 weeks
• CD10367 3% Solution - Desquamated zone
Once daily application for 3 weeks
• CD10367 solution placebo - Desquamated zone
Once daily application for 3 weeks

Locations

Country	Name	City	State
France	Galderma Investigational Site	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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