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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-002774-12 | EudraCT Number |
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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.
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:
on 4 mini-zones non-pretreated, would be tested:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CD10367 3% Solution - Non-desquamated zone | Experimental |
| |
| CD10367 1% Solution - Non-desquamated zone | Experimental |
| |
| CD10367 solution placebo - Non-desquamated zone | Placebo Comparator | CD10367 solution placebo serves as negative control. |
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| Betneval ointment - Non-desquamated zone | Active Comparator | This comparator containing Betamethasone valerate 0.1% serves as positive control. |
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| CD10367 3% Solution - Desquamated zone | Experimental |
| |
| CD10367 solution placebo - Desquamated zone | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CD10367 3% Solution - Non-desquamated zone | Drug | Once daily application for 3 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve (AUC) of Individual Clinical Scores | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Galderma Investigational Site | Nice | France |
A total of 29 participants were screened, of which 24 participants were enrolled and randomized to receive the study treatments on 6 target mini-zones (on upper and/or the lower extremities [elbows, knees and tibiae shin area excluded] and/or on the trunk).
The study was conducted at single center in France from 03-November-2016 to 24-March-2017.
| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | Participants received 50 microliter (mcL) of 3 percent (3%) CD10367 solution and their matched placebo topically, on one or two desquamated psoriatic plaque (pre-treated) and 50 mcL of 3%, 1% CD10367 solution, their matched placebo and Betneval® 0.1% (positive control) topically, on one or two non-desquamated psoriatic plaque once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 16, 2016 | Jun 29, 2023 |
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| 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 |
|
|
| CD10367 3% Solution - Desquamated zone | Drug | Once daily application for 3 weeks |
|
| CD10367 solution placebo - Desquamated zone | Drug | Once daily application for 3 weeks |
|
| Day 1 to Day 19 |
| Total Sum Score (TSS) of Individual Clinical Scores | 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). | Day 1, Day 4, Day 8, Day 11, Day 15 and Day 19 |
| Percent Change in Total Sum Score (TSS) | 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. | Day 1, Day 4, Day 8, Day 11, Day 15 and Day 19 |
| Erythema, Scaling and Induration Scores at Each Visit | 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. | 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 | 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. | Day 1, Day 4, Day 8, Day 11, Day 15, Day 19 |
| Number of Participants With Success Rate at Each Visit | 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). | Day 4, Day 8, Day 11, Day 15 and Day 19 |
| Time to First Success | 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). | Day 1 to Day 19 |
| COMPLETED |
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| NOT COMPLETED |
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Analysis was performed on intent to treat (ITT) population that included all randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Participants received 50 mcL of 3% CD10367 solution or their matched placebo topically, on one or two desquamated psoriatic plaque (pre-treated) and 50 mcL of 3% and 1% CD10367 solution or their matched placebo and Betneval® 0.1% (positive control) topically, on one or two non-desquamated psoriatic plaque (pre-treated) once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Analysis was performed on ITT population, which comprised of all participants who were randomized | Posted | Mean | Standard Deviation | score on a scale*days | Day 1 to Day 19 | mini-zones | mini-zones |
|
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Area Under the Curve (AUC) of Individual Clinical Scores | 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. | Analysis was performed on ITT population, which comprised all participants who were randomized | Posted | Mean | Standard Deviation | score on a scale*days | Day 1 to Day 19 | mini-zones | mini-zones |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Total Sum Score (TSS) of Individual Clinical Scores | 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). | Analysis was performed on ITT population, which comprised all participants who were randomized. | Posted | Mean | Standard Deviation | score on a scale | Day 1, Day 4, Day 8, Day 11, Day 15 and Day 19 | mini-zones | mini-zones |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change in Total Sum Score (TSS) | 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. | Analysis was performed on ITT population, which comprised all participants who were randomized. | Posted | Mean | Standard Deviation | percent change | Day 1, Day 4, Day 8, Day 11, Day 15 and Day 19 | mini-zones | mini-zones |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Erythema, Scaling and Induration Scores at Each Visit | 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. | Analysis was performed on ITT population, which comprised all participants who were randomized | Posted | Mean | Standard Deviation | score on scale | Day 1, Day 4, Day 8, Day 11, Day 15 and Day 19 | mini-zones | mini-zones |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Changes of Erythema, Scaling and Induration From Day 1 to 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. | Analysis was performed on ITT population, which comprised all participants who were randomized | Posted | Mean | Standard Deviation | percent change | Day 1, Day 4, Day 8, Day 11, Day 15, Day 19 | mini-zones | mini-zones |
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| Secondary | Number of Participants With Success Rate at Each Visit | 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). | Analysis was performed on ITT population, which comprised all participants who were randomized. | Posted | Count of Participants | Participants | Day 4, Day 8, Day 11, Day 15 and Day 19 |
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| Secondary | Time to First Success | 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). | Analysis was performed on ITT population, which comprised all participants who were randomized. | Posted | Count of Units | mini-zones | Day 1 to Day 19 | mini-zones | mini-zones |
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Adverse events were collected from the informed consent form signature (up to 3 weeks before Day 1) until follow up (up to Day 26).
Analysis was performed on safety population that included all participants who had received at least once the study treatment during the treatment period (from the day of first application of study treatment to the end of the study).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CD10367 Placebo Pretreated | Participants received 50 mcL matched placebo solution topically, on one or two desquamated psoriatic plaque (pre-treated), once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week. | 0 | 24 | 0 | 24 | 4 | 24 |
| EG001 | CD10367 3% Pretreated | Participants received 50 mcL 3% CD10367 solution topically, on one or two desquamated psoriatic plaque (pre-treated), once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week. | 0 | 24 | 0 | 24 | 4 | 24 |
| EG002 | CD10367 Placebo | Participants received matched placebo 50 mcL solution topically, on one or more psoriatic plaque, once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week. | 0 | 24 | 0 | 24 | 4 | 24 |
| EG003 | CD10367 1% | Participants received 50 mcL 1% CD10367 solution topically, on one or more psoriatic plaque, once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week. | 0 | 24 | 0 | 24 | 4 | 24 |
| EG004 | CD10367 3% | Participants received 50 mcL 3% CD10367 solution topically, on one or more psoriatic plaque, once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week. | 0 | 24 | 0 | 24 | 4 | 24 |
| EG005 | Betneval 0.1% | Participants received 50 mcL of 0.1% Betneval ointment topically, on one or more psoriatic plaque, once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week. | 0 | 24 | 0 | 24 | 4 | 24 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Operations | Galderma | 817 961 5000 | 1 | Clinical.Studies@galderma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 9, 2017 | Jun 29, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D001624 | Betamethasone Valerate |
| ID | Term |
|---|---|
| D001623 | Betamethasone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
Not provided
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
|
| mini-zones |
|
Participants received 50 mcL of 3% CD10367 solution topically, on one or two desquamated psoriatic plaque (pre-treated), once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week.
| OG002 | CD10367 Placebo | Participants received 50 mcL of matched placebo solution topically, on one or more psoriatic plaque, once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week. |
| OG003 | CD10367 1% | Participants received 50 mcL of 1% CD10367 solution topically, on one or more psoriatic plaque, once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week. |
| OG004 | CD10367 3% | Participants received 50 mcL of 3% CD10367 solution topically, on one or more psoriatic plaque, once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week. |
| OG005 | Betneval 0.1% | Participants received 50 mcL of 0.1% Betneval ointment topically, on one or more psoriatic plaque, once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week. |
|
|
Participants received 50 mcL of matched placebo solution topically, on one or more psoriatic plaque, once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week.
| OG003 | CD10367 1% | Participants received 50 mcL of 1% CD10367 solution topically, on one or more psoriatic plaque, once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week. |
| OG004 | CD10367 3% | Participants received 50 mcL of 3% CD10367 solution topically, on one or more psoriatic plaque, once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week. |
| OG005 | Betneval 0.1% | Participants received 50 mcL of 0.1% Betneval ointment topically, on one or more psoriatic plaque, once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week. |
|
|
| OG002 |
| CD10367 Placebo |
Participants received 50 mcL of matched placebo solution topically, on one or more psoriatic plaque, once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week. |
| OG003 | CD10367 1% | Participants received 50 mcL of 1% CD10367 solution topically, on one or more psoriatic plaque, once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week. |
| OG004 | CD10367 3% | Participants received 50 mcL of 3% CD10367 solution topically, on one or more psoriatic plaque, once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week. |
| OG005 | Betneval 0.1% | Participants received 50 mcL of 0.1% Betneval ointment topically, on one or more psoriatic plaque, once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week. |
|
|
Participants received 50 mcL of 3% CD10367 solution topically, on one or two desquamated psoriatic plaque (pre-treated), once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week.
| OG002 | CD10367 Placebo | Participants received 50 mcL of matched placebo solution topically, on one or more psoriatic plaque, once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week. |
| OG003 | CD10367 1% | Participants received 50 mcL of 1% CD10367 solution topically, on one or more psoriatic plaque, once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week. |
| OG004 | CD10367 3% | Participants received 50 mcL of 3% CD10367 solution topically, on one or more psoriatic plaque, once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week. |
| OG005 | Betneval 0.1% | Participants received 50 mcL of 0.1% Betneval ointment topically, on one or more psoriatic plaque, once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week. |
|
|
Participants received 50 mcL of 3% CD10367 solution topically, on one or two desquamated psoriatic plaque (pre-treated), once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week.
| OG002 | CD10367 Placebo | Participants received 50 mcL of matched placebo solution topically, on one or more psoriatic plaque, once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week. |
| OG003 | CD10367 1% | Participants received 50 mcL of 1% CD10367 solution topically, on one or more psoriatic plaque, once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week. |
| OG004 | CD10367 3% | Participants received 50 mcL of 3% CD10367 solution topically, on one or more psoriatic plaque, once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week. |
| OG005 | Betneval 0.1% | Participants received 50 mcL of 0.1% Betneval ointment topically, on one or more psoriatic plaque, once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week. |
|
|
| OG002 | CD10367 Placebo | Participants received 50 mcL of matched placebo solution topically, on one or more psoriatic plaque, once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week. |
| OG003 | CD10367 1% | Participants received 50 mcL of 1% CD10367 solution topically, on one or more psoriatic plaque, once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week. |
| OG004 | CD10367 3% | Participants received 50 mcL of 3% CD10367 solution topically, on one or more psoriatic plaque, once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week. |
| OG005 | Betneval 0.1% | Participants received 50 mcL of 0.1% Betneval ointment topically, on one or more psoriatic plaque, once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week. |
|
|
| OG003 | CD10367 1% | Participants received 50 mcL of 1% CD10367 solution topically, on one or more psoriatic plaque, once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week. |
| OG004 | CD10367 3% | Participants received 50 mcL of 3% CD10367 solution topically, on one or more psoriatic plaque, once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week. |
| OG005 | Betneval 0.1% | Participants received 50 mcL of 0.1% Betneval ointment topically, on one or more psoriatic plaque, once daily, for 5 consecutive days a week for 2 weeks and 4 consecutive days in the third week. |
|
|