Clinical trial NCT03025282: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis Vulgaris
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2017-01-19
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This was an exploratory, single-center, investigator blinded, randomized, controlled, intra-individual study, involving participants with psoriasis vulgaris.

The objective was 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 would be applied in each participant 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, would be tested:

  * CD10367 3% solution
  * CD10367 solution placebo
* on 4 mini-zones non-pretreated, would be tested:

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

Eligibility 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. Participant had a skin phototype I to IV on Fitzpatrick's scale. (Screening visit).
4. The participant had 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 participant presented 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. Participant agreed not to wear his/her contact lenses from the Baseline visit till the D19 visit (Screening visit).

Exclusion Criteria:

1. The participant presented guttate, erythrodermic, exfoliative, inverse, pustular, palmo plantar, infected or ulcerated psoriasis (Screening visit).
2. The participant had any uncontrolled or serious disease, or any medical or surgical condition, that might either interfere with the interpretation of the clinical trial results, and/or put the participant at significant risk (according to Investigator's judgment) if he/she participated in the clinical trial (e.g. history of on-going gastric or duodenal ulcer, clinically significant lung disease, etc.) (Screening visit).
3. The participant had 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 participant had known history of adverse drug reaction or hypersensitivity to a product with the same mode of action.
5. The participant had any abnormal clinically significant findings according to the ophthalmologist, at the ophthalmological exam at Screening visit,
6. The participant presented any abnormal laboratory tests judged clinically significant by the investigator (blood samplings and urinalysis done at Screening visit),
7. The participant had QTc interval \>450 millisecond (msec) or any abnormal electrocardiogram (ECG) value considered as clinically significant by the cardiologist (Screening visit).
8. The participant had received, applied or taken some specified treatments within the specified time frame prior to the Baseline visit.

Primary outcomes:
measure: Area Under the Curve (AUC) of Total Sum Score (Sum of Erythema, Scaling and Induration Scores)
timeFrame: Day 1 to Day 19
Secondary outcomes:
measure: Area Under the Curve (AUC) of Individual Clinical Scores
timeFrame: Day 1 to Day 19
measure: Total Sum Score (TSS) of Individual Clinical Scores
timeFrame: Day 1, Day 4, Day 8, Day 11, Day 15 and Day 19
measure: Percent Change in Total Sum Score (TSS)
timeFrame: Day 1, Day 4, Day 8, Day 11, Day 15 and Day 19
measure: Erythema, Scaling and Induration Scores at Each Visit
timeFrame: Day 1, Day 4, Day 8, Day 11, Day 15 and Day 19
measure: Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19
timeFrame: Day 1, Day 4, Day 8, Day 11, Day 15, Day 19
measure: Number of Participants With Success Rate at Each Visit
timeFrame: Day 4, Day 8, Day 11, Day 15 and Day 19
measure: Time to First Success
timeFrame: Day 1 to Day 19
Other outcomes:
Locations:
city: Nice
country: France
facility: Galderma Investigational Site
Study officials:
References: