Safety and Efficacy of CD10367 in Psoriasis Vulgaris

NCT03025282 | Completed Phase 2 Results

• 2 other identifiers: RD.03.SPR.1120752016-002774-12
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis Vulgaris

Outcome Measures

Primary Outcomes (1)

• Area Under the Curve (AUC) of Total Sum Score (Sum of Erythema, Scaling and Induration Scores)

  The TSS is the sum of the individual clinical scores of erythema, scaling and induration determined on a mini-zone. Each score was evaluated by the Investigator on all mini-zones using a 5-point scale (0: none; 1: mild; 2: moderate; 3: severe; 4: very severe) and were summed to obtain the Total Sum Score (TSS). Maximum total score was 12 (very severe); minimum total score was 0 (None). The mean AUC of TSSs were calculated for each intervention for all participants.

  Day 1 to Day 19

Secondary Outcomes (7)

• Area Under the Curve (AUC) of Individual Clinical Scores

  Day 1 to Day 19

• Total Sum Score (TSS) of Individual Clinical Scores

  Day 1, Day 4, Day 8, Day 11, Day 15 and Day 19

• Percent Change in Total Sum Score (TSS)

  Day 1, Day 4, Day 8, Day 11, Day 15 and Day 19

• Erythema, Scaling and Induration Scores at Each Visit

  Day 1, Day 4, Day 8, Day 11, Day 15 and Day 19

• Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19

  Day 1, Day 4, Day 8, Day 11, Day 15, Day 19

Study Arms (6)

CD10367 3% Solution - Non-desquamated zone

EXPERIMENTAL

Drug: CD10367 3% Solution - Non-desquamated zone

CD10367 1% Solution - Non-desquamated zone

EXPERIMENTAL

Drug: CD10367 1% Solution - Non-desquamated zone

CD10367 solution placebo - Non-desquamated zone

PLACEBO COMPARATOR

CD10367 solution placebo serves as negative control.

Drug: CD10367 solution placebo - Non-desquamated zone

Betneval ointment - Non-desquamated zone

ACTIVE COMPARATOR

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

Drug: Betneval ointment - Non-desquamated zone

CD10367 3% Solution - Desquamated zone

EXPERIMENTAL

Drug: CD10367 3% Solution - Desquamated zone

CD10367 solution placebo - Desquamated zone

PLACEBO COMPARATOR

Drug: CD10367 solution placebo - Desquamated zone

Interventions

CD10367 3% Solution - Non-desquamated zone DRUG

Once daily application for 3 weeks

CD10367 3% Solution - Non-desquamated zone

CD10367 1% Solution - Non-desquamated zone DRUG

Once daily application for 3 weeks

CD10367 1% Solution - Non-desquamated zone

CD10367 solution placebo - Non-desquamated zone DRUG

Once daily application for 3 weeks

CD10367 solution placebo - Non-desquamated zone

Betneval ointment - Non-desquamated zone DRUG

Once daily application for 3 weeks

Also known as: Betamethasone Valerate

Betneval ointment - Non-desquamated zone

CD10367 3% Solution - Desquamated zone DRUG

Once daily application for 3 weeks

CD10367 3% Solution - Desquamated zone

CD10367 solution placebo - Desquamated zone DRUG

Once daily application for 3 weeks

CD10367 solution placebo - Desquamated zone

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (1)

Galderma Investigational Site

Nice, France

Location

MeSH Terms

Interventions

Betamethasone Valerate

Intervention Hierarchy (Ancestors)

Betamethasone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Clinical Operations
• Organization: Galderma

Clinical.Studies@galderma.com

817 961 5000

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2017
• First Posted: January 19, 2017
• Study Start: November 3, 2016
• Primary Completion: March 24, 2017
• Study Completion: March 24, 2017
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-04

Locations

FR (1)