Efficacy and Safety Study of CD 2027 Spray in Subjects With Plaque-type Psoriasis

DSS is the sum of all the individual score of evaluated target lesion that includes plaque elevation (abnormal thickness of the psoriasis lesion), erythema (abnormal redness of the skin), and scaling (shedding of the stratum corneum). Each individual parameters evaluated the affected area by using a 5-point scale ranging from 0 to 4, that is, 0 = None; 1 = Mild; 2 = Moderate; 3 = Severe and 4 =Very severe, where higher score indicated worst condition. All missing values were imputed by last observation carried forward (LOCF). The total score of each parameter ranges from 0-12, where higher score indicated worst condition.

Time frame: Baseline, Week 8

Population: ITT population is defined as all participants who were randomized and to whom medication is dispensed.

Erythema (abnormal redness of skin) score is a 5-point scale: 0=None (No detectable erythema. Skin of normal color); 1=Mild (Slight pinkness present); 2=Moderate (Definite redness, easily recognized); 3=Severe (Intense redness) and 4=Severe (Very Intense redness). Scaling (shedding of stratum corneum) score is a 5- point scale: 0=None (No shedding); 1=Mild (Barely perceptible shedding, noticeable only on light scratching or rubbing); 2=Moderate (Obvious but not profuse shedding); 3=Severe (heavy scale production) and 4=Very severe (very thick scales). Plaque elevation (abnormal thickness of psoriasis lesion) score was a 5- point scale: 0=None (Normal skin thickness. No elevation of skin); 1=Mild (Barely perceptible elevation (by touching) of psoriasis plaques); 2=Moderate (Obvious elevation above normal skin level; moderate thickening); 3=Severe (definite thick elevation above normal skin level) and 4=Severe (Very thick elevation).

Time frame: Baseline, Week 8

Population: ITT population is defined as all participants who were randomized and to whom medication is dispensed.

Success Rate 1 was defined as percentage of participants who achieved at least 2-grade improvement from Baseline on Global Severity Score (GSS) at Week 8. GSS is a 5-point scale which ranges from 0-4, where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe, higher score indicated higher severity. All missing values were imputed by last observation carried forward (LOCF).

Time frame: Week 8

Population: ITT population is defined as all participants who were randomized and to whom medication is dispensed.

Success Rate 2 was defined as percentage of participants who achieved clear or almost clear on GSS at Week 8. GSS is a 5-point scale which ranges from 0-4, where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe, higher score indicated higher severity. All missing values were imputed by last observation carried forward (LOCF).

Time frame: Week 8

Population: ITT population is defined as all participants who were randomized and to whom medication is dispensed.

Change from baseline in Blood Chemistry: Alkaline Phosphatase, AST and ALT were reported.

Time frame: Baseline, Week 8

Population: The Safety population is defined as all participants in the ITT population who have applied the study medication at least once. Here, Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure.

Change from baseline in Blood Chemistry: Bilirubin Direct, Bilirubin Total, BUN and Creatinine were reported.

Time frame: Baseline, Week 8

Population: The Safety population is defined as all participants in the ITT population who have applied the study medication at least once. Here, Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure.

Change from baseline in calcitriol plasma levels were reported.

Time frame: Baseline, Week 8

Population: The Safety population is defined as all participants in the ITT population who have applied the study medication at least once. Here, Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure.

Change from baseline in serum calcium homeostasis parameter (Albumin) were reported.

Time frame: Baseline, Week 8

Population: The Safety population is defined as all participants in the ITT population who have applied the study medication at least once. Here, Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure.

Change from baseline in serum calcium homeostasis parameter (Albumin-adjusted calcium) were reported.

Time frame: Baseline, Week 8

Population: The Safety population is defined as all participants in the ITT population who have applied the study medication at least once. Here, Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure.

Change from baseline in serum calcium homeostasis parameter (Calcium) were reported.

Time frame: Baseline, Week 8

Population: The Safety population is defined as all participants in the ITT population who have applied the study medication at least once. Here, Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure.

Change from baseline in serum calcium homeostasis parameter (PTH intact) were reported.

Time frame: Baseline, Week 8

Population: The Safety population is defined as all participants in the ITT population who have applied the study medication at least once. Here, Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure

Change from baseline in serum calcium homeostasis parameter (Phosphorus) were reported.

Time frame: Baseline, Week 8

Population: The Safety population is defined as all participants in the ITT population who have applied the study medication at least once. Here, Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure.

Change from baseline in vital sign parameter: heart rate was reported.

Time frame: Baseline, Week 8

Population: The Safety population is defined as all participants in the ITT population who have applied the study medication at least once. Here, Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure.

Change from baseline in vital sign parameter: Systolic Blood Pressure and Diastolic Blood Pressure was reported.

Time frame: Baseline, Week 8

Population: The Safety population is defined as all participants in the ITT population who have applied the study medication at least once. Here, Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure.

AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily had a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

Time frame: up to Week 8

Population: The Safety population is defined as all participants in the ITT population who have applied the study medication at least once.

Local tolerability skin assessments were performed by the investigator and based on 5-point scale which ranges from 0 to 4. 0 = none (no evidence of local intolerance); 1=mild (minimal erythema and/or edema, slight glazed appearance); 2 = moderate (definite erythema and/or edema with peeling and/or cracking but needs no adaptation of posology); 3 = severe (erythema, edema glazing with fissures, few vesicles or papules) and 4 = very severe (strong reaction spreading beyond the treated area, bullous reaction, erosions). Higher grades indicated worsening of condition. Percentage of participants with increase in score by Week 8 from baseline has been presented here, where the row titles indicate participant's new scores by Week 8.

Time frame: up to Week 8

Population: The Safety population is defined as all participants in the ITT population who have applied the study medication at least once.