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Completed

NCT Number: NCT03025282

Safety and Efficacy of CD10367 in Psoriasis Vulgaris

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.

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Key information

Conditions

Psoriasis Vulgaris

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Galderma Investigational Site

Nice, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).
  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

CD10367 3% Solution - Non-desquamated zone

Drug

Once daily application for 3 weeks

CD10367 1% Solution - Non-desquamated zone

Drug

Once daily application for 3 weeks

CD10367 solution placebo - Non-desquamated zone

Drug

Once daily application for 3 weeks

Betneval ointment - Non-desquamated zone

Drug

Once daily application for 3 weeks

Other names: Betamethasone Valerate

CD10367 3% Solution - Desquamated zone

Drug

Once daily application for 3 weeks

CD10367 solution placebo - Desquamated zone

Drug

Once daily application for 3 weeks

Primary outcomes

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

    Time frame: Day 1 to Day 19

    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.

Secondary outcomes

  1. Area Under the Curve (AUC) of Individual Clinical Scores

    Time frame: Day 1 to Day 19

    Each mini zone was evaluated by recording individual clinical scores (items: erythema, scaling, induration) for each participant using 5-point scale for each item and score ranged from 0(none), 1(mild), 2(moderate), 3(severe) and 4(very severe). Erythema: 0=No detectable erythema,1=Slight pinkness present, 2=Definite redness, easily recognized, 3=Intense redness, 4=Very intense redness; Scaling: 0=No shedding, 1=Barely perceptible shedding, noticeable only on light scratching or rubbing, 2=Obvious but not profuse shedding, 3=Heavy scale production, 4=Very thick scales; Induration: 0=Normal skin thickness/No elevation of skin, 1=Barely perceptible elevation (by touching) of the psoriasis plaques, 2=Obvious elevation above normal skin level/moderate thickening, 3=Definite thick elevation above normal skin level, 4=Very thick elevation. Higher score indicated worst conditions. The mean AUC for each intervention was calculated for each participant.

  2. Total Sum Score (TSS) of Individual Clinical Scores

    Time frame: Day 1, Day 4, Day 8, Day 11, Day 15 and Day 19

    The TSS was 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). where maximum total score was 12 (worst condition) and minimum total score was 0 (no symptoms).

  3. Percent Change in Total Sum Score (TSS)

    Time frame: Day 1, Day 4, Day 8, Day 11, Day 15 and Day 19

    The TSS was 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). where maximum score was 12 (worst condition) and minimum score was 0 (no symptoms). The TSS percentage change from Day 1 at each visit and erythema, scaling and induration scores and their changes from Day 1 at each visit were evaluated by visit and by treatment received.

  4. Erythema, Scaling and Induration Scores at Each Visit

    Time frame: Day 1, Day 4, Day 8, Day 11, Day 15 and Day 19

    Status of psoriasis for each mini zone was evaluated by recording individual clinical scores (items: erythema, scaling, induration) using 5-point scale for each item and score ranged from 0(none), 1(mild), 2(moderate), 3(severe) and 4(very severe). Erythema: 0=No detectable erythema,1=Slight pinkness present, 2=Definite redness, easily recognized, 3=Intense redness, 4=Very intense redness; Scaling: 0=No shedding, 1=Barely perceptible shedding, noticeable only on light scratching or rubbing, 2=Obvious but not profuse shedding, 3=Heavy scale production, 4=Very thick scales; Induration: 0=Normal skin thickness/No elevation of skin, 1=Barely perceptible elevation (by touching) of the psoriasis plaques, 2=Obvious elevation above normal skin level/moderate thickening, 3=Definite thick elevation above normal skin level, 4=Very thick elevation. Higher score indicated worst conditions.

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

    Time frame: Day 1, Day 4, Day 8, Day 11, Day 15, Day 19

    Status of psoriasis for each mini zone was evaluated by recording individual clinical scores (items: erythema, scaling, induration) using 5-point scale for each item and score ranged from 0(none), 1(mild), 2(moderate), 3(severe) and 4(very severe). Erythema: 0=No detectable erythema,1=Slight pinkness present, 2=Definite redness, easily recognized, 3=Intense redness, 4=Very intense redness; Scaling: 0=No shedding, 1=Barely perceptible shedding, noticeable only on light scratching or rubbing, 2=Obvious but not profuse shedding, 3=Heavy scale production, 4=Very thick scales; Induration: 0=Normal skin thickness/No elevation of skin, 1=Barely perceptible elevation (by touching) of the psoriasis plaques, 2=Obvious elevation above normal skin level/moderate thickening, 3=Definite thick elevation above normal skin level, 4=Very thick elevation. Higher score indicated worst conditions.

  6. Number of Participants With Success Rate at Each Visit

    Time frame: Day 4, Day 8, Day 11, Day 15 and Day 19

    Success rate was defined as a clearing score of 0 or 1, at each evaluation visit (Day 4, Day 8, Day 11, Day 15 and Day 19). The clearing score was ranged from 0 to 2, where scores were indicated as follows: 0=complete clearing (no scaling and no infiltration even on palpation. Post inflammatory hypo- or hyperpigmentation might be present, 1=almost clear (Residual erythema with some induration/infiltration [not clinically visible but palpable] without scaling, or residual erythema and residual scaling with no infiltration, 2=unchanged (unchanged or less than almost clear). Higher score indicated less success in clearing condition (worse outcome).

  7. Time to First Success

    Time frame: Day 1 to Day 19

    The time to first success was defined as 0=no Success at any day, 1=success at Day 19 and not before, 2=success at Day 15 and not before, 3=success at Day 11 and not before, where lower score indicated less success in clearing condition (worse outcome).

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 19, 2017
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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