Psoriasis Vulgaris
Conditions
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
Interventions
DRUGCD10367 3% Solution - Non-desquamated zone
Once daily application for 3 weeks
DRUGCD10367 1% Solution - Non-desquamated zone
Once daily application for 3 weeks
DRUGCD10367 solution placebo - Non-desquamated zone
Once daily application for 3 weeks
DRUGBetneval ointment - Non-desquamated zone
Once daily application for 3 weeks
DRUGCD10367 3% Solution - Desquamated zone
Once daily application for 3 weeks
DRUGCD10367 solution placebo - Desquamated zone
Once daily application for 3 weeks
Sponsors
Galderma R&D
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Curve (AUC) of Total Sum Score (Sum of Erythema, Scaling and Induration Scores) | 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
| Measure | Time frame | Description |
|---|---|---|
| Total Sum Score (TSS) of Individual Clinical Scores | 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). |
| Percent Change in Total Sum Score (TSS) | 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. |
| Erythema, Scaling and Induration Scores at Each Visit | 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. |
| Area Under the Curve (AUC) of Individual Clinical Scores | 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. |
| Number of Participants With Success Rate at Each Visit | 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). |
| Time to First Success | 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). |
| 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 | 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. |
Countries
France
Participant flow
Recruitment details
The study was conducted at single center in France from 03-November-2016 to 24-March-2017.
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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. | 24 |
| Total | 24 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 52.0 years STANDARD_DEVIATION 9.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 24 Participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 24 | 0 / 24 | 0 / 24 | 0 / 24 | 0 / 24 |
| other Total, other adverse events | 4 / 24 | 4 / 24 | 4 / 24 | 4 / 24 | 4 / 24 | 4 / 24 |
| serious Total, serious adverse events | 0 / 24 | 0 / 24 | 0 / 24 | 0 / 24 | 0 / 24 | 0 / 24 |
Outcome results
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.
Time frame: Day 1 to Day 19
Population: Analysis was performed on ITT population, which comprised of all participants who were randomized
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CD10367 Placebo Pretreated | Area Under the Curve (AUC) of Total Sum Score (Sum of Erythema, Scaling and Induration Scores) | 103.4 score on a scale*days | Standard Deviation 24.5 |
| CD10367 3% Pretreated | Area Under the Curve (AUC) of Total Sum Score (Sum of Erythema, Scaling and Induration Scores) | 101.7 score on a scale*days | Standard Deviation 22.5 |
| CD10367 Placebo | Area Under the Curve (AUC) of Total Sum Score (Sum of Erythema, Scaling and Induration Scores) | 118.0 score on a scale*days | Standard Deviation 23.2 |
| CD10367 1% | Area Under the Curve (AUC) of Total Sum Score (Sum of Erythema, Scaling and Induration Scores) | 118.6 score on a scale*days | Standard Deviation 24 |
| CD10367 3% | Area Under the Curve (AUC) of Total Sum Score (Sum of Erythema, Scaling and Induration Scores) | 116.6 score on a scale*days | Standard Deviation 26.3 |
| Betneval 0.1% | Area Under the Curve (AUC) of Total Sum Score (Sum of Erythema, Scaling and Induration Scores) | 75.3 score on a scale*days | Standard Deviation 16.3 |
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.
Time frame: Day 1 to Day 19
Population: Analysis was performed on ITT population, which comprised all participants who were randomized
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CD10367 Placebo Pretreated | Area Under the Curve (AUC) of Individual Clinical Scores | Scaling | 32.3 score on a scale*days | Standard Deviation 12.8 |
| CD10367 Placebo Pretreated | Area Under the Curve (AUC) of Individual Clinical Scores | Induration | 34.0 score on a scale*days | Standard Deviation 5.6 |
| CD10367 Placebo Pretreated | Area Under the Curve (AUC) of Individual Clinical Scores | Erythema | 37.1 score on a scale*days | Standard Deviation 7.7 |
| CD10367 3% Pretreated | Area Under the Curve (AUC) of Individual Clinical Scores | Scaling | 31.1 score on a scale*days | Standard Deviation 11.3 |
| CD10367 3% Pretreated | Area Under the Curve (AUC) of Individual Clinical Scores | Erythema | 37.7 score on a scale*days | Standard Deviation 7.6 |
| CD10367 3% Pretreated | Area Under the Curve (AUC) of Individual Clinical Scores | Induration | 32.9 score on a scale*days | Standard Deviation 6.2 |
| CD10367 Placebo | Area Under the Curve (AUC) of Individual Clinical Scores | Induration | 36.9 score on a scale*days | Standard Deviation 7.2 |
| CD10367 Placebo | Area Under the Curve (AUC) of Individual Clinical Scores | Erythema | 42.7 score on a scale*days | Standard Deviation 7.5 |
| CD10367 Placebo | Area Under the Curve (AUC) of Individual Clinical Scores | Scaling | 38.4 score on a scale*days | Standard Deviation 11 |
| CD10367 1% | Area Under the Curve (AUC) of Individual Clinical Scores | Scaling | 40.2 score on a scale*days | Standard Deviation 11.8 |
| CD10367 1% | Area Under the Curve (AUC) of Individual Clinical Scores | Erythema | 41.3 score on a scale*days | Standard Deviation 7.7 |
| CD10367 1% | Area Under the Curve (AUC) of Individual Clinical Scores | Induration | 37.1 score on a scale*days | Standard Deviation 7 |
| CD10367 3% | Area Under the Curve (AUC) of Individual Clinical Scores | Erythema | 41.7 score on a scale*days | Standard Deviation 8.6 |
| CD10367 3% | Area Under the Curve (AUC) of Individual Clinical Scores | Induration | 35.3 score on a scale*days | Standard Deviation 7.8 |
| CD10367 3% | Area Under the Curve (AUC) of Individual Clinical Scores | Scaling | 39.6 score on a scale*days | Standard Deviation 12.6 |
| Betneval 0.1% | Area Under the Curve (AUC) of Individual Clinical Scores | Scaling | 20.5 score on a scale*days | Standard Deviation 4.9 |
| Betneval 0.1% | Area Under the Curve (AUC) of Individual Clinical Scores | Erythema | 27.2 score on a scale*days | Standard Deviation 7.4 |
| Betneval 0.1% | Area Under the Curve (AUC) of Individual Clinical Scores | Induration | 27.5 score on a scale*days | Standard Deviation 5.8 |
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.
Time frame: Day 1, Day 4, Day 8, Day 11, Day 15 and Day 19
Population: Analysis was performed on ITT population, which comprised all participants who were randomized
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CD10367 Placebo Pretreated | Erythema, Scaling and Induration Scores at Each Visit | Induration: Day 15 | 1.9 score on scale | Standard Deviation 0.6 |
| CD10367 Placebo Pretreated | Erythema, Scaling and Induration Scores at Each Visit | Scaling: Day 8 | 2.1 score on scale | Standard Deviation 0.8 |
| CD10367 Placebo Pretreated | Erythema, Scaling and Induration Scores at Each Visit | Induration: Day 4 | 2.0 score on scale | Standard Deviation 0.2 |
| CD10367 Placebo Pretreated | Erythema, Scaling and Induration Scores at Each Visit | Erythema: Day 4 | 2.0 score on scale | Standard Deviation 0.4 |
| CD10367 Placebo Pretreated | Erythema, Scaling and Induration Scores at Each Visit | Erythema: Day 11 | 2.0 score on scale | Standard Deviation 0.5 |
| CD10367 Placebo Pretreated | Erythema, Scaling and Induration Scores at Each Visit | Scaling: Day 1 | 1.0 score on scale | Standard Deviation 0.2 |
| CD10367 Placebo Pretreated | Erythema, Scaling and Induration Scores at Each Visit | Induration: Day 19 | 1.6 score on scale | Standard Deviation 0.8 |
| CD10367 Placebo Pretreated | Erythema, Scaling and Induration Scores at Each Visit | Induration: Day 1 | 2.0 score on scale | Standard Deviation 0 |
| CD10367 Placebo Pretreated | Erythema, Scaling and Induration Scores at Each Visit | Erythema: Day 8 | 2.3 score on scale | Standard Deviation 0.6 |
| CD10367 Placebo Pretreated | Erythema, Scaling and Induration Scores at Each Visit | Scaling: Day 19 | 1.7 score on scale | Standard Deviation 1 |
| CD10367 Placebo Pretreated | Erythema, Scaling and Induration Scores at Each Visit | Erythema: Day 15 | 2.0 score on scale | Standard Deviation 0.7 |
| CD10367 Placebo Pretreated | Erythema, Scaling and Induration Scores at Each Visit | Induration: Day 11 | 1.8 score on scale | Standard Deviation 0.5 |
| CD10367 Placebo Pretreated | Erythema, Scaling and Induration Scores at Each Visit | Erythema: Day 1 | 2.0 score on scale | Standard Deviation 0.2 |
| CD10367 Placebo Pretreated | Erythema, Scaling and Induration Scores at Each Visit | Scaling: Day 4 | 1.5 score on scale | Standard Deviation 0.7 |
| CD10367 Placebo Pretreated | Erythema, Scaling and Induration Scores at Each Visit | Scaling: Day 15 | 2.0 score on scale | Standard Deviation 1 |
| CD10367 Placebo Pretreated | Erythema, Scaling and Induration Scores at Each Visit | Erythema: Day 19 | 1.9 score on scale | Standard Deviation 0.7 |
| CD10367 Placebo Pretreated | Erythema, Scaling and Induration Scores at Each Visit | Induration: Day 8 | 2.0 score on scale | Standard Deviation 0.3 |
| CD10367 Placebo Pretreated | Erythema, Scaling and Induration Scores at Each Visit | Scaling: Day 11 | 1.9 score on scale | Standard Deviation 0.9 |
| CD10367 3% Pretreated | Erythema, Scaling and Induration Scores at Each Visit | Erythema: Day 1 | 2.0 score on scale | Standard Deviation 0.2 |
| CD10367 3% Pretreated | Erythema, Scaling and Induration Scores at Each Visit | Scaling: Day 8 | 2.0 score on scale | Standard Deviation 0.8 |
| CD10367 3% Pretreated | Erythema, Scaling and Induration Scores at Each Visit | Scaling: Day 1 | 1.0 score on scale | Standard Deviation 0.2 |
| CD10367 3% Pretreated | Erythema, Scaling and Induration Scores at Each Visit | Scaling: Day 4 | 1.5 score on scale | Standard Deviation 0.8 |
| CD10367 3% Pretreated | Erythema, Scaling and Induration Scores at Each Visit | Induration: Day 15 | 1.8 score on scale | Standard Deviation 0.6 |
| CD10367 3% Pretreated | Erythema, Scaling and Induration Scores at Each Visit | Induration: Day 11 | 1.7 score on scale | Standard Deviation 0.6 |
| CD10367 3% Pretreated | Erythema, Scaling and Induration Scores at Each Visit | Erythema: Day 4 | 2.1 score on scale | Standard Deviation 0.5 |
| CD10367 3% Pretreated | Erythema, Scaling and Induration Scores at Each Visit | Induration: Day 8 | 1.9 score on scale | Standard Deviation 0.4 |
| CD10367 3% Pretreated | Erythema, Scaling and Induration Scores at Each Visit | Erythema: Day 8 | 2.3 score on scale | Standard Deviation 0.5 |
| CD10367 3% Pretreated | Erythema, Scaling and Induration Scores at Each Visit | Induration: Day 19 | 1.6 score on scale | Standard Deviation 0.6 |
| CD10367 3% Pretreated | Erythema, Scaling and Induration Scores at Each Visit | Induration: Day 4 | 1.9 score on scale | Standard Deviation 0.3 |
| CD10367 3% Pretreated | Erythema, Scaling and Induration Scores at Each Visit | Induration: Day 1 | 2.0 score on scale | Standard Deviation 0 |
| CD10367 3% Pretreated | Erythema, Scaling and Induration Scores at Each Visit | Erythema: Day 11 | 2.1 score on scale | Standard Deviation 0.6 |
| CD10367 3% Pretreated | Erythema, Scaling and Induration Scores at Each Visit | Scaling: Day 19 | 1.4 score on scale | Standard Deviation 0.6 |
| CD10367 3% Pretreated | Erythema, Scaling and Induration Scores at Each Visit | Erythema: Day 15 | 2.1 score on scale | Standard Deviation 0.6 |
| CD10367 3% Pretreated | Erythema, Scaling and Induration Scores at Each Visit | Scaling: Day 15 | 1.8 score on scale | Standard Deviation 0.9 |
| CD10367 3% Pretreated | Erythema, Scaling and Induration Scores at Each Visit | Erythema: Day 19 | 1.8 score on scale | Standard Deviation 0.5 |
| CD10367 3% Pretreated | Erythema, Scaling and Induration Scores at Each Visit | Scaling: Day 11 | 2.0 score on scale | Standard Deviation 0.9 |
| CD10367 Placebo | Erythema, Scaling and Induration Scores at Each Visit | Erythema: Day 4 | 2.5 score on scale | Standard Deviation 0.6 |
| CD10367 Placebo | Erythema, Scaling and Induration Scores at Each Visit | Scaling: Day 8 | 2.4 score on scale | Standard Deviation 0.7 |
| CD10367 Placebo | Erythema, Scaling and Induration Scores at Each Visit | Erythema: Day 1 | 2.6 score on scale | Standard Deviation 0.5 |
| CD10367 Placebo | Erythema, Scaling and Induration Scores at Each Visit | Erythema: Day 8 | 2.5 score on scale | Standard Deviation 0.6 |
| CD10367 Placebo | Erythema, Scaling and Induration Scores at Each Visit | Erythema: Day 11 | 2.3 score on scale | Standard Deviation 0.5 |
| CD10367 Placebo | Erythema, Scaling and Induration Scores at Each Visit | Erythema: Day 15 | 2.3 score on scale | Standard Deviation 0.6 |
| CD10367 Placebo | Erythema, Scaling and Induration Scores at Each Visit | Erythema: Day 19 | 2.0 score on scale | Standard Deviation 0.6 |
| CD10367 Placebo | Erythema, Scaling and Induration Scores at Each Visit | Scaling: Day 1 | 2.5 score on scale | Standard Deviation 0.5 |
| CD10367 Placebo | Erythema, Scaling and Induration Scores at Each Visit | Scaling: Day 4 | 2.2 score on scale | Standard Deviation 0.6 |
| CD10367 Placebo | Erythema, Scaling and Induration Scores at Each Visit | Scaling: Day 11 | 2.0 score on scale | Standard Deviation 0.8 |
| CD10367 Placebo | Erythema, Scaling and Induration Scores at Each Visit | Scaling: Day 15 | 2.0 score on scale | Standard Deviation 0.9 |
| CD10367 Placebo | Erythema, Scaling and Induration Scores at Each Visit | Scaling: Day 19 | 1.7 score on scale | Standard Deviation 0.8 |
| CD10367 Placebo | Erythema, Scaling and Induration Scores at Each Visit | Induration: Day 1 | 2.2 score on scale | Standard Deviation 0.4 |
| CD10367 Placebo | Erythema, Scaling and Induration Scores at Each Visit | Induration: Day 4 | 2.1 score on scale | Standard Deviation 0.3 |
| CD10367 Placebo | Erythema, Scaling and Induration Scores at Each Visit | Induration: Day 8 | 2.2 score on scale | Standard Deviation 0.4 |
| CD10367 Placebo | Erythema, Scaling and Induration Scores at Each Visit | Induration: Day 11 | 1.8 score on scale | Standard Deviation 0.6 |
| CD10367 Placebo | Erythema, Scaling and Induration Scores at Each Visit | Induration: Day 15 | 2.1 score on scale | Standard Deviation 0.6 |
| CD10367 Placebo | Erythema, Scaling and Induration Scores at Each Visit | Induration: Day 19 | 1.9 score on scale | Standard Deviation 0.5 |
| CD10367 1% | Erythema, Scaling and Induration Scores at Each Visit | Erythema: Day 11 | 2.2 score on scale | Standard Deviation 0.7 |
| CD10367 1% | Erythema, Scaling and Induration Scores at Each Visit | Induration: Day 11 | 2.0 score on scale | Standard Deviation 0.6 |
| CD10367 1% | Erythema, Scaling and Induration Scores at Each Visit | Induration: Day 19 | 1.9 score on scale | Standard Deviation 0.5 |
| CD10367 1% | Erythema, Scaling and Induration Scores at Each Visit | Induration: Day 1 | 2.2 score on scale | Standard Deviation 0.4 |
| CD10367 1% | Erythema, Scaling and Induration Scores at Each Visit | Scaling: Day 11 | 2.2 score on scale | Standard Deviation 0.9 |
| CD10367 1% | Erythema, Scaling and Induration Scores at Each Visit | Erythema: Day 4 | 2.4 score on scale | Standard Deviation 0.7 |
| CD10367 1% | Erythema, Scaling and Induration Scores at Each Visit | Scaling: Day 15 | 2.3 score on scale | Standard Deviation 0.9 |
| CD10367 1% | Erythema, Scaling and Induration Scores at Each Visit | Erythema: Day 8 | 2.3 score on scale | Standard Deviation 0.6 |
| CD10367 1% | Erythema, Scaling and Induration Scores at Each Visit | Induration: Day 8 | 2.2 score on scale | Standard Deviation 0.5 |
| CD10367 1% | Erythema, Scaling and Induration Scores at Each Visit | Induration: Day 4 | 2.0 score on scale | Standard Deviation 0.4 |
| CD10367 1% | Erythema, Scaling and Induration Scores at Each Visit | Erythema: Day 19 | 2.1 score on scale | Standard Deviation 0.4 |
| CD10367 1% | Erythema, Scaling and Induration Scores at Each Visit | Scaling: Day 8 | 2.3 score on scale | Standard Deviation 0.9 |
| CD10367 1% | Erythema, Scaling and Induration Scores at Each Visit | Scaling: Day 4 | 2.3 score on scale | Standard Deviation 0.7 |
| CD10367 1% | Erythema, Scaling and Induration Scores at Each Visit | Induration: Day 15 | 2.1 score on scale | Standard Deviation 0.5 |
| CD10367 1% | Erythema, Scaling and Induration Scores at Each Visit | Scaling: Day 1 | 2.5 score on scale | Standard Deviation 0.5 |
| CD10367 1% | Erythema, Scaling and Induration Scores at Each Visit | Scaling: Day 19 | 1.7 score on scale | Standard Deviation 1 |
| CD10367 1% | Erythema, Scaling and Induration Scores at Each Visit | Erythema: Day 15 | 2.3 score on scale | Standard Deviation 0.5 |
| CD10367 1% | Erythema, Scaling and Induration Scores at Each Visit | Erythema: Day 1 | 2.5 score on scale | Standard Deviation 0.5 |
| CD10367 3% | Erythema, Scaling and Induration Scores at Each Visit | Scaling: Day 8 | 2.3 score on scale | Standard Deviation 1 |
| CD10367 3% | Erythema, Scaling and Induration Scores at Each Visit | Erythema: Day 19 | 2.0 score on scale | Standard Deviation 0.6 |
| CD10367 3% | Erythema, Scaling and Induration Scores at Each Visit | Scaling: Day 11 | 2.1 score on scale | Standard Deviation 1.1 |
| CD10367 3% | Erythema, Scaling and Induration Scores at Each Visit | Erythema: Day 15 | 2.4 score on scale | Standard Deviation 0.6 |
| CD10367 3% | Erythema, Scaling and Induration Scores at Each Visit | Induration: Day 15 | 2.0 score on scale | Standard Deviation 0.6 |
| CD10367 3% | Erythema, Scaling and Induration Scores at Each Visit | Scaling: Day 15 | 2.1 score on scale | Standard Deviation 0.9 |
| CD10367 3% | Erythema, Scaling and Induration Scores at Each Visit | Erythema: Day 11 | 2.2 score on scale | Standard Deviation 0.7 |
| CD10367 3% | Erythema, Scaling and Induration Scores at Each Visit | Scaling: Day 19 | 1.7 score on scale | Standard Deviation 0.8 |
| CD10367 3% | Erythema, Scaling and Induration Scores at Each Visit | Induration: Day 1 | 2.1 score on scale | Standard Deviation 0.3 |
| CD10367 3% | Erythema, Scaling and Induration Scores at Each Visit | Erythema: Day 8 | 2.4 score on scale | Standard Deviation 0.7 |
| CD10367 3% | Erythema, Scaling and Induration Scores at Each Visit | Induration: Day 4 | 2.1 score on scale | Standard Deviation 0.4 |
| CD10367 3% | Erythema, Scaling and Induration Scores at Each Visit | Erythema: Day 4 | 2.3 score on scale | Standard Deviation 0.6 |
| CD10367 3% | Erythema, Scaling and Induration Scores at Each Visit | Induration: Day 8 | 2.0 score on scale | Standard Deviation 0.6 |
| CD10367 3% | Erythema, Scaling and Induration Scores at Each Visit | Induration: Day 11 | 1.8 score on scale | Standard Deviation 0.7 |
| CD10367 3% | Erythema, Scaling and Induration Scores at Each Visit | Erythema: Day 1 | 2.6 score on scale | Standard Deviation 0.5 |
| CD10367 3% | Erythema, Scaling and Induration Scores at Each Visit | Scaling: Day 1 | 2.6 score on scale | Standard Deviation 0.5 |
| CD10367 3% | Erythema, Scaling and Induration Scores at Each Visit | Induration: Day 19 | 1.8 score on scale | Standard Deviation 0.7 |
| CD10367 3% | Erythema, Scaling and Induration Scores at Each Visit | Scaling: Day 4 | 2.4 score on scale | Standard Deviation 0.6 |
| Betneval 0.1% | Erythema, Scaling and Induration Scores at Each Visit | Induration: Day 1 | 2.1 score on scale | Standard Deviation 0.3 |
| Betneval 0.1% | Erythema, Scaling and Induration Scores at Each Visit | Erythema: Day 1 | 2.5 score on scale | Standard Deviation 0.5 |
| Betneval 0.1% | Erythema, Scaling and Induration Scores at Each Visit | Scaling: Day 11 | 0.8 score on scale | Standard Deviation 0.5 |
| Betneval 0.1% | Erythema, Scaling and Induration Scores at Each Visit | Erythema: Day 8 | 1.5 score on scale | Standard Deviation 0.5 |
| Betneval 0.1% | Erythema, Scaling and Induration Scores at Each Visit | Scaling: Day 8 | 1.3 score on scale | Standard Deviation 0.4 |
| Betneval 0.1% | Erythema, Scaling and Induration Scores at Each Visit | Induration: Day 11 | 1.3 score on scale | Standard Deviation 0.5 |
| Betneval 0.1% | Erythema, Scaling and Induration Scores at Each Visit | Scaling: Day 4 | 1.2 score on scale | Standard Deviation 0.5 |
| Betneval 0.1% | Erythema, Scaling and Induration Scores at Each Visit | Scaling: Day 19 | 0.7 score on scale | Standard Deviation 0.5 |
| Betneval 0.1% | Erythema, Scaling and Induration Scores at Each Visit | Scaling: Day 1 | 2.5 score on scale | Standard Deviation 0.5 |
| Betneval 0.1% | Erythema, Scaling and Induration Scores at Each Visit | Erythema: Day 19 | 1.1 score on scale | Standard Deviation 0.5 |
| Betneval 0.1% | Erythema, Scaling and Induration Scores at Each Visit | Induration: Day 15 | 1.3 score on scale | Standard Deviation 0.5 |
| Betneval 0.1% | Erythema, Scaling and Induration Scores at Each Visit | Induration: Day 4 | 1.8 score on scale | Standard Deviation 0.4 |
| Betneval 0.1% | Erythema, Scaling and Induration Scores at Each Visit | Erythema: Day 4 | 1.5 score on scale | Standard Deviation 0.6 |
| Betneval 0.1% | Erythema, Scaling and Induration Scores at Each Visit | Scaling: Day 15 | 1.0 score on scale | Standard Deviation 0.4 |
| Betneval 0.1% | Erythema, Scaling and Induration Scores at Each Visit | Induration: Day 19 | 1.1 score on scale | Standard Deviation 0.5 |
| Betneval 0.1% | Erythema, Scaling and Induration Scores at Each Visit | Erythema: Day 15 | 1.4 score on scale | Standard Deviation 0.6 |
| Betneval 0.1% | Erythema, Scaling and Induration Scores at Each Visit | Erythema: Day 11 | 1.3 score on scale | Standard Deviation 0.5 |
| Betneval 0.1% | Erythema, Scaling and Induration Scores at Each Visit | Induration: Day 8 | 1.7 score on scale | Standard Deviation 0.5 |
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).
Time frame: Day 4, Day 8, Day 11, Day 15 and Day 19
Population: Analysis was performed on ITT population, which comprised all participants who were randomized.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CD10367 Placebo Pretreated | Number of Participants With Success Rate at Each Visit | Day 8: No | 24 Participants |
| CD10367 Placebo Pretreated | Number of Participants With Success Rate at Each Visit | Day 8: Yes | 0 Participants |
| CD10367 Placebo Pretreated | Number of Participants With Success Rate at Each Visit | Day 19: No | 23 Participants |
| CD10367 Placebo Pretreated | Number of Participants With Success Rate at Each Visit | Day 19: Yes | 1 Participants |
| CD10367 Placebo Pretreated | Number of Participants With Success Rate at Each Visit | Day 15: No | 23 Participants |
| CD10367 Placebo Pretreated | Number of Participants With Success Rate at Each Visit | Day 15: Yes | 1 Participants |
| CD10367 Placebo Pretreated | Number of Participants With Success Rate at Each Visit | Day 4: No | 24 Participants |
| CD10367 Placebo Pretreated | Number of Participants With Success Rate at Each Visit | Day 4: Yes | 0 Participants |
| CD10367 Placebo Pretreated | Number of Participants With Success Rate at Each Visit | Day 11: No | 24 Participants |
| CD10367 Placebo Pretreated | Number of Participants With Success Rate at Each Visit | Day 11: Yes | 0 Participants |
| CD10367 3% Pretreated | Number of Participants With Success Rate at Each Visit | Day 4: No | 24 Participants |
| CD10367 3% Pretreated | Number of Participants With Success Rate at Each Visit | Day 4: Yes | 0 Participants |
| CD10367 3% Pretreated | Number of Participants With Success Rate at Each Visit | Day 8: Yes | 0 Participants |
| CD10367 3% Pretreated | Number of Participants With Success Rate at Each Visit | Day 8: No | 24 Participants |
| CD10367 3% Pretreated | Number of Participants With Success Rate at Each Visit | Day 11: Yes | 0 Participants |
| CD10367 3% Pretreated | Number of Participants With Success Rate at Each Visit | Day 11: No | 24 Participants |
| CD10367 3% Pretreated | Number of Participants With Success Rate at Each Visit | Day 15: Yes | 0 Participants |
| CD10367 3% Pretreated | Number of Participants With Success Rate at Each Visit | Day 15: No | 24 Participants |
| CD10367 3% Pretreated | Number of Participants With Success Rate at Each Visit | Day 19: Yes | 1 Participants |
| CD10367 3% Pretreated | Number of Participants With Success Rate at Each Visit | Day 19: No | 23 Participants |
| CD10367 Placebo | Number of Participants With Success Rate at Each Visit | Day 8: No | 24 Participants |
| CD10367 Placebo | Number of Participants With Success Rate at Each Visit | Day 15: No | 24 Participants |
| CD10367 Placebo | Number of Participants With Success Rate at Each Visit | Day 4: Yes | 0 Participants |
| CD10367 Placebo | Number of Participants With Success Rate at Each Visit | Day 11: Yes | 0 Participants |
| CD10367 Placebo | Number of Participants With Success Rate at Each Visit | Day 8: Yes | 0 Participants |
| CD10367 Placebo | Number of Participants With Success Rate at Each Visit | Day 4: No | 24 Participants |
| CD10367 Placebo | Number of Participants With Success Rate at Each Visit | Day 11: No | 24 Participants |
| CD10367 Placebo | Number of Participants With Success Rate at Each Visit | Day 19: Yes | 0 Participants |
| CD10367 Placebo | Number of Participants With Success Rate at Each Visit | Day 19: No | 24 Participants |
| CD10367 Placebo | Number of Participants With Success Rate at Each Visit | Day 15: Yes | 0 Participants |
| CD10367 1% | Number of Participants With Success Rate at Each Visit | Day 15: Yes | 0 Participants |
| CD10367 1% | Number of Participants With Success Rate at Each Visit | Day 15: No | 24 Participants |
| CD10367 1% | Number of Participants With Success Rate at Each Visit | Day 4: No | 24 Participants |
| CD10367 1% | Number of Participants With Success Rate at Each Visit | Day 19: No | 23 Participants |
| CD10367 1% | Number of Participants With Success Rate at Each Visit | Day 19: Yes | 1 Participants |
| CD10367 1% | Number of Participants With Success Rate at Each Visit | Day 4: Yes | 0 Participants |
| CD10367 1% | Number of Participants With Success Rate at Each Visit | Day 11: No | 24 Participants |
| CD10367 1% | Number of Participants With Success Rate at Each Visit | Day 11: Yes | 0 Participants |
| CD10367 1% | Number of Participants With Success Rate at Each Visit | Day 8: No | 24 Participants |
| CD10367 1% | Number of Participants With Success Rate at Each Visit | Day 8: Yes | 0 Participants |
| CD10367 3% | Number of Participants With Success Rate at Each Visit | Day 15: Yes | 0 Participants |
| CD10367 3% | Number of Participants With Success Rate at Each Visit | Day 8: No | 24 Participants |
| CD10367 3% | Number of Participants With Success Rate at Each Visit | Day 11: Yes | 0 Participants |
| CD10367 3% | Number of Participants With Success Rate at Each Visit | Day 11: No | 24 Participants |
| CD10367 3% | Number of Participants With Success Rate at Each Visit | Day 4: Yes | 0 Participants |
| CD10367 3% | Number of Participants With Success Rate at Each Visit | Day 15: No | 24 Participants |
| CD10367 3% | Number of Participants With Success Rate at Each Visit | Day 19: No | 23 Participants |
| CD10367 3% | Number of Participants With Success Rate at Each Visit | Day 19: Yes | 1 Participants |
| CD10367 3% | Number of Participants With Success Rate at Each Visit | Day 8: Yes | 0 Participants |
| CD10367 3% | Number of Participants With Success Rate at Each Visit | Day 4: No | 24 Participants |
| Betneval 0.1% | Number of Participants With Success Rate at Each Visit | Day 11: No | 19 Participants |
| Betneval 0.1% | Number of Participants With Success Rate at Each Visit | Day 19: No | 17 Participants |
| Betneval 0.1% | Number of Participants With Success Rate at Each Visit | Day 4: No | 24 Participants |
| Betneval 0.1% | Number of Participants With Success Rate at Each Visit | Day 8: Yes | 0 Participants |
| Betneval 0.1% | Number of Participants With Success Rate at Each Visit | Day 11: Yes | 5 Participants |
| Betneval 0.1% | Number of Participants With Success Rate at Each Visit | Day 15: Yes | 2 Participants |
| Betneval 0.1% | Number of Participants With Success Rate at Each Visit | Day 8: No | 24 Participants |
| Betneval 0.1% | Number of Participants With Success Rate at Each Visit | Day 15: No | 22 Participants |
| Betneval 0.1% | Number of Participants With Success Rate at Each Visit | Day 4: Yes | 0 Participants |
| Betneval 0.1% | Number of Participants With Success Rate at Each Visit | Day 19: Yes | 7 Participants |
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.
Time frame: Day 1, Day 4, Day 8, Day 11, Day 15 and Day 19
Population: Analysis was performed on ITT population, which comprised all participants who were randomized.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CD10367 Placebo Pretreated | Percent Change in Total Sum Score (TSS) | Day 8 | 28.3 percent change | Standard Deviation 26.8 |
| CD10367 Placebo Pretreated | Percent Change in Total Sum Score (TSS) | Day 15 | 17.6 percent change | Standard Deviation 38.5 |
| CD10367 Placebo Pretreated | Percent Change in Total Sum Score (TSS) | Day 11 | 15.0 percent change | Standard Deviation 30.6 |
| CD10367 Placebo Pretreated | Percent Change in Total Sum Score (TSS) | Day 4 | 9.7 percent change | Standard Deviation 20 |
| CD10367 Placebo Pretreated | Percent Change in Total Sum Score (TSS) | Day 19 | 3.4 percent change | Standard Deviation 43.3 |
| CD10367 3% Pretreated | Percent Change in Total Sum Score (TSS) | Day 15 | 14.4 percent change | Standard Deviation 31.4 |
| CD10367 3% Pretreated | Percent Change in Total Sum Score (TSS) | Day 8 | 24.1 percent change | Standard Deviation 25.5 |
| CD10367 3% Pretreated | Percent Change in Total Sum Score (TSS) | Day 11 | 16.1 percent change | Standard Deviation 32.2 |
| CD10367 3% Pretreated | Percent Change in Total Sum Score (TSS) | Day 4 | 11.6 percent change | Standard Deviation 24.1 |
| CD10367 3% Pretreated | Percent Change in Total Sum Score (TSS) | Day 19 | -5.8 percent change | Standard Deviation 25.5 |
| CD10367 Placebo | Percent Change in Total Sum Score (TSS) | Day 8 | -2.9 percent change | Standard Deviation 11 |
| CD10367 Placebo | Percent Change in Total Sum Score (TSS) | Day 4 | -7.3 percent change | Standard Deviation 11.4 |
| CD10367 Placebo | Percent Change in Total Sum Score (TSS) | Day 19 | -22.3 percent change | Standard Deviation 18 |
| CD10367 Placebo | Percent Change in Total Sum Score (TSS) | Day 15 | -11.7 percent change | Standard Deviation 21.9 |
| CD10367 Placebo | Percent Change in Total Sum Score (TSS) | Day 11 | -17.4 percent change | Standard Deviation 20.3 |
| CD10367 1% | Percent Change in Total Sum Score (TSS) | Day 8 | -6.1 percent change | Standard Deviation 17.7 |
| CD10367 1% | Percent Change in Total Sum Score (TSS) | Day 19 | -22.0 percent change | Standard Deviation 19.4 |
| CD10367 1% | Percent Change in Total Sum Score (TSS) | Day 4 | -7.4 percent change | Standard Deviation 14.7 |
| CD10367 1% | Percent Change in Total Sum Score (TSS) | Day 15 | -7.4 percent change | Standard Deviation 21.4 |
| CD10367 1% | Percent Change in Total Sum Score (TSS) | Day 11 | -12.2 percent change | Standard Deviation 21.2 |
| CD10367 3% | Percent Change in Total Sum Score (TSS) | Day 19 | -26.6 percent change | Standard Deviation 19.1 |
| CD10367 3% | Percent Change in Total Sum Score (TSS) | Day 4 | -7.8 percent change | Standard Deviation 13 |
| CD10367 3% | Percent Change in Total Sum Score (TSS) | Day 8 | -8.5 percent change | Standard Deviation 20.6 |
| CD10367 3% | Percent Change in Total Sum Score (TSS) | Day 11 | -17.0 percent change | Standard Deviation 22.7 |
| CD10367 3% | Percent Change in Total Sum Score (TSS) | Day 15 | -11.7 percent change | Standard Deviation 17.2 |
| Betneval 0.1% | Percent Change in Total Sum Score (TSS) | Day 15 | -48.1 percent change | Standard Deviation 14.9 |
| Betneval 0.1% | Percent Change in Total Sum Score (TSS) | Day 11 | -51.9 percent change | Standard Deviation 13.2 |
| Betneval 0.1% | Percent Change in Total Sum Score (TSS) | Day 8 | -36.9 percent change | Standard Deviation 14.1 |
| Betneval 0.1% | Percent Change in Total Sum Score (TSS) | Day 19 | -58.4 percent change | Standard Deviation 16.6 |
| Betneval 0.1% | Percent Change in Total Sum Score (TSS) | Day 4 | -36.6 percent change | Standard Deviation 13.3 |
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.
Time frame: Day 1, Day 4, Day 8, Day 11, Day 15, Day 19
Population: Analysis was performed on ITT population, which comprised all participants who were randomized
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CD10367 Placebo Pretreated | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Induration: Day 8 | 0.0 percent change | Standard Deviation 0.3 |
| CD10367 Placebo Pretreated | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Erythema: Day 15 | -0.0 percent change | Standard Deviation 0.6 |
| CD10367 Placebo Pretreated | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Erythema: Day 8 | 0.3 percent change | Standard Deviation 0.5 |
| CD10367 Placebo Pretreated | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Erythema: Day 4 | -0.0 percent change | Standard Deviation 0.4 |
| CD10367 Placebo Pretreated | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Scaling: Day 11 | 1.0 percent change | Standard Deviation 1 |
| CD10367 Placebo Pretreated | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Induration: Day 15 | -0.1 percent change | Standard Deviation 0.6 |
| CD10367 Placebo Pretreated | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Induration: Day 19 | -0.4 percent change | Standard Deviation 0.8 |
| CD10367 Placebo Pretreated | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Induration: Day 11 | -0.2 percent change | Standard Deviation 0.5 |
| CD10367 Placebo Pretreated | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Scaling: Day 4 | 0.6 percent change | Standard Deviation 0.7 |
| CD10367 Placebo Pretreated | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Erythema: Day 19 | -0.1 percent change | Standard Deviation 0.7 |
| CD10367 Placebo Pretreated | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Scaling: Day 19 | 0.7 percent change | Standard Deviation 1 |
| CD10367 Placebo Pretreated | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Scaling: Day 15 | 1.0 percent change | Standard Deviation 1 |
| CD10367 Placebo Pretreated | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Induration: Day 4 | -0.0 percent change | Standard Deviation 0.2 |
| CD10367 Placebo Pretreated | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Scaling: Day 8 | 1.2 percent change | Standard Deviation 0.8 |
| CD10367 Placebo Pretreated | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Erythema: Day 11 | 0.0 percent change | Standard Deviation 0.4 |
| CD10367 3% Pretreated | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Scaling: Day 8 | 1.1 percent change | Standard Deviation 0.7 |
| CD10367 3% Pretreated | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Erythema: Day 19 | -0.3 percent change | Standard Deviation 0.4 |
| CD10367 3% Pretreated | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Scaling: Day 4 | 0.6 percent change | Standard Deviation 0.8 |
| CD10367 3% Pretreated | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Induration: Day 19 | -0.4 percent change | Standard Deviation 0.6 |
| CD10367 3% Pretreated | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Induration: Day 11 | -0.3 percent change | Standard Deviation 0.6 |
| CD10367 3% Pretreated | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Erythema: Day 4 | 0.1 percent change | Standard Deviation 0.5 |
| CD10367 3% Pretreated | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Induration: Day 8 | -0.1 percent change | Standard Deviation 0.4 |
| CD10367 3% Pretreated | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Erythema: Day 8 | 0.2 percent change | Standard Deviation 0.5 |
| CD10367 3% Pretreated | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Induration: Day 15 | -0.2 percent change | Standard Deviation 0.6 |
| CD10367 3% Pretreated | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Erythema: Day 11 | 0.1 percent change | Standard Deviation 0.6 |
| CD10367 3% Pretreated | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Scaling: Day 15 | 0.9 percent change | Standard Deviation 0.9 |
| CD10367 3% Pretreated | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Scaling: Day 11 | 1.0 percent change | Standard Deviation 0.9 |
| CD10367 3% Pretreated | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Scaling: Day 19 | 0.4 percent change | Standard Deviation 0.6 |
| CD10367 3% Pretreated | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Induration: Day 4 | -0.1 percent change | Standard Deviation 0.3 |
| CD10367 3% Pretreated | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Erythema: Day 15 | -0.0 percent change | Standard Deviation 0.6 |
| CD10367 Placebo | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Induration: Day 19 | -0.3 percent change | Standard Deviation 0.4 |
| CD10367 Placebo | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Erythema: Day 11 | -0.4 percent change | Standard Deviation 0.7 |
| CD10367 Placebo | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Induration: Day 15 | -0.0 percent change | Standard Deviation 0.6 |
| CD10367 Placebo | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Scaling: Day 15 | -0.5 percent change | Standard Deviation 0.8 |
| CD10367 Placebo | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Scaling: Day 4 | -0.4 percent change | Standard Deviation 0.6 |
| CD10367 Placebo | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Scaling: Day 19 | -0.8 percent change | Standard Deviation 0.8 |
| CD10367 Placebo | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Scaling: Day 11 | -0.5 percent change | Standard Deviation 0.8 |
| CD10367 Placebo | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Erythema: Day 19 | -0.6 percent change | Standard Deviation 0.8 |
| CD10367 Placebo | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Induration: Day 8 | 0.0 percent change | Standard Deviation 0.3 |
| CD10367 Placebo | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Induration: Day 11 | -0.4 percent change | Standard Deviation 0.5 |
| CD10367 Placebo | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Erythema: Day 4 | -0.1 percent change | Standard Deviation 0.4 |
| CD10367 Placebo | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Scaling: Day 8 | -0.1 percent change | Standard Deviation 0.5 |
| CD10367 Placebo | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Erythema: Day 15 | -0.3 percent change | Standard Deviation 0.7 |
| CD10367 Placebo | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Erythema: Day 8 | -0.1 percent change | Standard Deviation 0.4 |
| CD10367 Placebo | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Induration: Day 4 | -0.0 percent change | Standard Deviation 0.2 |
| CD10367 1% | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Erythema: Day 4 | -0.1 percent change | Standard Deviation 0.4 |
| CD10367 1% | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Induration: Day 4 | -0.1 percent change | Standard Deviation 0.3 |
| CD10367 1% | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Erythema: Day 19 | -0.5 percent change | Standard Deviation 0.5 |
| CD10367 1% | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Erythema: Day 11 | -0.3 percent change | Standard Deviation 0.8 |
| CD10367 1% | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Erythema: Day 8 | -0.2 percent change | Standard Deviation 0.5 |
| CD10367 1% | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Scaling: Day 11 | -0.3 percent change | Standard Deviation 1 |
| CD10367 1% | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Scaling: Day 4 | -0.3 percent change | Standard Deviation 0.8 |
| CD10367 1% | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Induration: Day 11 | -0.2 percent change | Standard Deviation 0.4 |
| CD10367 1% | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Scaling: Day 19 | -0.8 percent change | Standard Deviation 1 |
| CD10367 1% | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Scaling: Day 15 | -0.3 percent change | Standard Deviation 0.9 |
| CD10367 1% | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Induration: Day 15 | -0.0 percent change | Standard Deviation 0.5 |
| CD10367 1% | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Scaling: Day 8 | -0.2 percent change | Standard Deviation 0.9 |
| CD10367 1% | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Induration: Day 19 | -0.3 percent change | Standard Deviation 0.5 |
| CD10367 1% | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Erythema: Day 15 | -0.3 percent change | Standard Deviation 0.6 |
| CD10367 1% | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Induration: Day 8 | 0.0 percent change | Standard Deviation 0.3 |
| CD10367 3% | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Scaling: Day 8 | -0.3 percent change | Standard Deviation 1 |
| CD10367 3% | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Induration: Day 11 | -0.3 percent change | Standard Deviation 0.6 |
| CD10367 3% | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Induration: Day 15 | -0.2 percent change | Standard Deviation 0.5 |
| CD10367 3% | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Induration: Day 19 | -0.3 percent change | Standard Deviation 0.6 |
| CD10367 3% | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Erythema: Day 4 | -3.0 percent change | Standard Deviation 0.5 |
| CD10367 3% | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Erythema: Day 8 | -0.2 percent change | Standard Deviation 0.6 |
| CD10367 3% | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Scaling: Day 11 | -0.5 percent change | Standard Deviation 1 |
| CD10367 3% | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Scaling: Day 15 | -0.5 percent change | Standard Deviation 0.7 |
| CD10367 3% | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Erythema: Day 11 | -0.4 percent change | Standard Deviation 0.8 |
| CD10367 3% | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Scaling: Day 19 | -0.9 percent change | Standard Deviation 0.6 |
| CD10367 3% | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Induration: Day 4 | -0.0 percent change | Standard Deviation 0.4 |
| CD10367 3% | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Erythema: Day 15 | -0.2 percent change | Standard Deviation 0.7 |
| CD10367 3% | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Erythema: Day 19 | -0.7 percent change | Standard Deviation 0.6 |
| CD10367 3% | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Scaling: Day 4 | -0.2 percent change | Standard Deviation 0.5 |
| CD10367 3% | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Induration: Day 8 | -0.1 percent change | Standard Deviation 0.4 |
| Betneval 0.1% | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Erythema: Day 19 | -1.4 percent change | Standard Deviation 0.7 |
| Betneval 0.1% | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Erythema: Day 15 | -1.1 percent change | Standard Deviation 0.7 |
| Betneval 0.1% | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Induration: Day 4 | -0.3 percent change | Standard Deviation 0.5 |
| Betneval 0.1% | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Scaling: Day 19 | -1.8 percent change | Standard Deviation 0.7 |
| Betneval 0.1% | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Scaling: Day 8 | -1.3 percent change | Standard Deviation 0.6 |
| Betneval 0.1% | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Erythema: Day 11 | -1.2 percent change | Standard Deviation 0.6 |
| Betneval 0.1% | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Scaling: Day 15 | -1.5 percent change | Standard Deviation 0.6 |
| Betneval 0.1% | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Scaling: Day 11 | -1.7 percent change | Standard Deviation 0.6 |
| Betneval 0.1% | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Erythema: Day 8 | -1.0 percent change | Standard Deviation 0.4 |
| Betneval 0.1% | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Erythema: Day 4 | -1.0 percent change | Standard Deviation 0.6 |
| Betneval 0.1% | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Induration: Day 19 | -0.1 percent change | Standard Deviation 0.5 |
| Betneval 0.1% | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Induration: Day 11 | -0.8 percent change | Standard Deviation 0.4 |
| Betneval 0.1% | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Induration: Day 8 | -0.4 percent change | Standard Deviation 0.5 |
| Betneval 0.1% | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Induration: Day 15 | -0.8 percent change | Standard Deviation 0.4 |
| Betneval 0.1% | Percent Changes of Erythema, Scaling and Induration From Day 1 to Day 19 | Scaling: Day 4 | -1.3 percent change | Standard Deviation 0.6 |
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).
Time frame: Day 1 to Day 19
Population: Analysis was performed on ITT population, which comprised all participants who were randomized.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| CD10367 Placebo Pretreated | Time to First Success | 3-Success at Day 11 and not before | 0 mini-zones |
| CD10367 Placebo Pretreated | Time to First Success | 2-Success at Day 15 and not before | 1 mini-zones |
| CD10367 Placebo Pretreated | Time to First Success | 1-Success at Day 19 and not before | 0 mini-zones |
| CD10367 Placebo Pretreated | Time to First Success | 0-No success at any day | 23 mini-zones |
| CD10367 3% Pretreated | Time to First Success | 3-Success at Day 11 and not before | 0 mini-zones |
| CD10367 3% Pretreated | Time to First Success | 0-No success at any day | 23 mini-zones |
| CD10367 3% Pretreated | Time to First Success | 2-Success at Day 15 and not before | 0 mini-zones |
| CD10367 3% Pretreated | Time to First Success | 1-Success at Day 19 and not before | 1 mini-zones |
| CD10367 Placebo | Time to First Success | 0-No success at any day | 24 mini-zones |
| CD10367 Placebo | Time to First Success | 3-Success at Day 11 and not before | 0 mini-zones |
| CD10367 Placebo | Time to First Success | 1-Success at Day 19 and not before | 0 mini-zones |
| CD10367 Placebo | Time to First Success | 2-Success at Day 15 and not before | 0 mini-zones |
| CD10367 1% | Time to First Success | 3-Success at Day 11 and not before | 0 mini-zones |
| CD10367 1% | Time to First Success | 2-Success at Day 15 and not before | 0 mini-zones |
| CD10367 1% | Time to First Success | 0-No success at any day | 23 mini-zones |
| CD10367 1% | Time to First Success | 1-Success at Day 19 and not before | 1 mini-zones |
| CD10367 3% | Time to First Success | 1-Success at Day 19 and not before | 1 mini-zones |
| CD10367 3% | Time to First Success | 2-Success at Day 15 and not before | 0 mini-zones |
| CD10367 3% | Time to First Success | 0-No success at any day | 23 mini-zones |
| CD10367 3% | Time to First Success | 3-Success at Day 11 and not before | 0 mini-zones |
| Betneval 0.1% | Time to First Success | 3-Success at Day 11 and not before | 5 mini-zones |
| Betneval 0.1% | Time to First Success | 0-No success at any day | 15 mini-zones |
| Betneval 0.1% | Time to First Success | 1-Success at Day 19 and not before | 4 mini-zones |
| Betneval 0.1% | Time to First Success | 2-Success at Day 15 and not before | 0 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).
Time frame: Day 1, Day 4, Day 8, Day 11, Day 15 and Day 19
Population: Analysis was performed on ITT population, which comprised all participants who were randomized.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CD10367 Placebo Pretreated | Total Sum Score (TSS) of Individual Clinical Scores | Day 8 | 6.4 score on a scale | Standard Deviation 1.4 |
| CD10367 Placebo Pretreated | Total Sum Score (TSS) of Individual Clinical Scores | Day 15 | 5.9 score on a scale | Standard Deviation 2.1 |
| CD10367 Placebo Pretreated | Total Sum Score (TSS) of Individual Clinical Scores | Day 4 | 5.5 score on a scale | Standard Deviation 1.1 |
| CD10367 Placebo Pretreated | Total Sum Score (TSS) of Individual Clinical Scores | Day 11 | 5.8 score on a scale | Standard Deviation 1.6 |
| CD10367 Placebo Pretreated | Total Sum Score (TSS) of Individual Clinical Scores | Day 1 | 5.0 score on a scale | Standard Deviation 0.3 |
| CD10367 Placebo Pretreated | Total Sum Score (TSS) of Individual Clinical Scores | Day 19 | 5.2 score on a scale | Standard Deviation 2.3 |
| CD10367 3% Pretreated | Total Sum Score (TSS) of Individual Clinical Scores | Day 15 | 5.8 score on a scale | Standard Deviation 1.8 |
| CD10367 3% Pretreated | Total Sum Score (TSS) of Individual Clinical Scores | Day 11 | 5.8 score on a scale | Standard Deviation 1.8 |
| CD10367 3% Pretreated | Total Sum Score (TSS) of Individual Clinical Scores | Day 1 | 5.0 score on a scale | Standard Deviation 0.3 |
| CD10367 3% Pretreated | Total Sum Score (TSS) of Individual Clinical Scores | Day 4 | 5.6 score on a scale | Standard Deviation 1.3 |
| CD10367 3% Pretreated | Total Sum Score (TSS) of Individual Clinical Scores | Day 19 | 4.8 score on a scale | Standard Deviation 1.5 |
| CD10367 3% Pretreated | Total Sum Score (TSS) of Individual Clinical Scores | Day 8 | 6.2 score on a scale | Standard Deviation 1.4 |
| CD10367 Placebo | Total Sum Score (TSS) of Individual Clinical Scores | Day 15 | 6.5 score on a scale | Standard Deviation 1.9 |
| CD10367 Placebo | Total Sum Score (TSS) of Individual Clinical Scores | Day 11 | 6.0 score on a scale | Standard Deviation 1.7 |
| CD10367 Placebo | Total Sum Score (TSS) of Individual Clinical Scores | Day 8 | 7.1 score on a scale | Standard Deviation 1.3 |
| CD10367 Placebo | Total Sum Score (TSS) of Individual Clinical Scores | Day 19 | 5.7 score on a scale | Standard Deviation 1.5 |
| CD10367 Placebo | Total Sum Score (TSS) of Individual Clinical Scores | Day 1 | 7.3 score on a scale | Standard Deviation 1 |
| CD10367 Placebo | Total Sum Score (TSS) of Individual Clinical Scores | Day 4 | 6.8 score on a scale | Standard Deviation 1.3 |
| CD10367 1% | Total Sum Score (TSS) of Individual Clinical Scores | Day 11 | 6.4 score on a scale | Standard Deviation 1.8 |
| CD10367 1% | Total Sum Score (TSS) of Individual Clinical Scores | Day 1 | 7.3 score on a scale | Standard Deviation 1 |
| CD10367 1% | Total Sum Score (TSS) of Individual Clinical Scores | Day 4 | 6.7 score on a scale | Standard Deviation 1.4 |
| CD10367 1% | Total Sum Score (TSS) of Individual Clinical Scores | Day 8 | 6.8 score on a scale | Standard Deviation 1.8 |
| CD10367 1% | Total Sum Score (TSS) of Individual Clinical Scores | Day 15 | 6.7 score on a scale | Standard Deviation 1.6 |
| CD10367 1% | Total Sum Score (TSS) of Individual Clinical Scores | Day 19 | 5.7 score on a scale | Standard Deviation 1.7 |
| CD10367 3% | Total Sum Score (TSS) of Individual Clinical Scores | Day 1 | 7.3 score on a scale | Standard Deviation 1 |
| CD10367 3% | Total Sum Score (TSS) of Individual Clinical Scores | Day 4 | 6.8 score on a scale | Standard Deviation 1.3 |
| CD10367 3% | Total Sum Score (TSS) of Individual Clinical Scores | Day 8 | 6.8 score on a scale | Standard Deviation 1.9 |
| CD10367 3% | Total Sum Score (TSS) of Individual Clinical Scores | Day 11 | 6.1 score on a scale | Standard Deviation 2.1 |
| CD10367 3% | Total Sum Score (TSS) of Individual Clinical Scores | Day 15 | 6.5 score on a scale | Standard Deviation 1.6 |
| CD10367 3% | Total Sum Score (TSS) of Individual Clinical Scores | Day 19 | 5.5 score on a scale | Standard Deviation 1.9 |
| Betneval 0.1% | Total Sum Score (TSS) of Individual Clinical Scores | Day 15 | 3.7 score on a scale | Standard Deviation 1.2 |
| Betneval 0.1% | Total Sum Score (TSS) of Individual Clinical Scores | Day 8 | 4.5 score on a scale | Standard Deviation 1.1 |
| Betneval 0.1% | Total Sum Score (TSS) of Individual Clinical Scores | Day 4 | 4.5 score on a scale | Standard Deviation 1.2 |
| Betneval 0.1% | Total Sum Score (TSS) of Individual Clinical Scores | Day 1 | 7.2 score on a scale | Standard Deviation 1 |
| Betneval 0.1% | Total Sum Score (TSS) of Individual Clinical Scores | Day 11 | 3.5 score on a scale | Standard Deviation 1.1 |
| Betneval 0.1% | Total Sum Score (TSS) of Individual Clinical Scores | Day 19 | 3.0 score on a scale | Standard Deviation 1.3 |