A Maximal Use Trial Evaluating the Pharmacokinetic Profile of MC2-01 Cream

• Sponsor: MC2 Therapeutics (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03462927
• Collaborator: (none)
• Enrollment: 63
• Location: 1
• Arms: 2
• Actual Duration (Months): 5.8
• Patients Per Site Per Month: 10.8

Study Details

Study Description

Brief Summary

This is a phase 2, randomised, open-label, parallel-group, multicentre trial in which MC2-01 cream and calcipotriene [CAL]/betamethasone [BDP] ointment (comparator) is investigated in subjects with clinically diagnosed extensive psoriasis vulgaris.

Condition or Disease	Intervention/Treatment	Phase
Psoriasis Vulgaris	Drug: MC2-01 Cream; Drug: CAL/BDP combination	Phase 2

Detailed Description

The MC2-01 cream is designed for optimal patient satisfaction - it quickly absorbs into the skin leaving it nicely moisturized allowing patients to move on with daily routines. In this trial, the MC2-01 cream will be compared to a marketed calcipotriene [CAL]/betamethasone dipropionate [BDP] ointment. The purpose of the trial, is to determine the pharmacokinetic parameters of MC2-01 cream and the comparator under maximum use conditions.

Study Design

• Study Type: Interventional
• Actual Enrollment: 63 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomised, Open-label, Maximal Use Trial, Evaluating the Pharmacokinetic Profile of Active Ingredients and Their Metabolites After Application of MC2-01 Cream Compared With Active Comparator in Subjects With Extensive Psoriasis Vulgaris
• Actual Study Start Date: Feb 8, 2018
• Actual Primary Completion Date: Aug 4, 2018
• Actual Study Completion Date: Aug 4, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MC2-01 Cream MC2-01 cream (CAL and BDP, w/w 0.005%/ 0.064%).	Drug: MC2-01 Cream; MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%)
Active Comparator: CAL/BDP combination CAL/BDP ointment (w/w 0.005%/0.064%).	Drug: CAL/BDP combination; Calcipotriene/betamethasone (calcipotriene/ betamethasone dipropionate, w/w 0.005%/0.064%)

Outcome Measures

Primary Outcome Measures

1. Maximum Plasma Concentration (Cmax) of the Active Ingredient Calcipotriene [Week 4]

   Geometric Mean for Maximum Plasma Concentration [Cmax] for the active ingredient Calcipotriene. Plasma concentration was measured at the following timepoints: pre-dose, 30 min, 1, 2, 3, 5 and 7 hours post-dose

2. Maximum Plasma Concentration (Cmax) of the Active Ingredient Calcipotriene [Week 8]

   Geometric Mean for Maximum Plasma Concentration [Cmax] for the active ingredient Calcipotriene. Plasma concentration was measured at the following timepoints: pre-dose, 30 min, 1, 2, 3, 5 and 7 hours post-dose

3. Maximum Plasma Concentration (Cmax) of Active Ingredient Betamethasone Dipropionate [Week 4]

   Geometric Mean for Maximum Plasma Concentration [Cmax] for the active ingredient Betamethasone Dipropionate. Plasma concentration was measured at the following timepoints: pre-dose, 30 min, 1, 2, 3, 5 and 7 hours post-dose

4. Maximum Plasma Concentration (Cmax) of Active Ingredient Betamethasone Dipropionate [Week 8]

   Geometric Mean for Maximum Plasma Concentration [Cmax] for the active ingredient Betamethasone Dipropionate. Plasma concentration was measured at the following timepoints: pre-dose, 30 min, 1, 2, 3, 5 and 7 hours post-dose

5. Maximum Plasma Concentration (Cmax) of the Metabolite MC1080 [Week 4]

   Geometric Mean for Maximum Plasma Concentration [Cmax] for the metabolite MC1080. Plasma concentration was measured at the following timepoints: pre-dose, 30 min, 1, 2, 3, 5 and 7 hours post-dose

6. Maximum Plasma Concentration (Cmax) of the Metabolite MC1080 [Week 8]

   Geometric Mean for Maximum Plasma Concentration [Cmax] for the metabolite MC1080. Plasma concentration was measured at the following timepoints: pre-dose, 30 min, 1, 2, 3, 5 and 7 hours post-dose

7. Maximum Plasma Concentration (Cmax) of Metabolite Betamethasone 17-propionate [Week 4]

   Geometric Mean for Maximum Plasma Concentration [Cmax] for the metabolite Betamethasone 17-propionate. Plasma concentration was measured at the following timepoints: pre-dose, 30 min, 1, 2, 3, 5 and 7 hours post-dose

8. Maximum Plasma Concentration (Cmax) of Metabolite Betamethasone 17-propionate [Week 8]

   Geometric Mean for Maximum Plasma Concentration [Cmax] for the metabolite Betamethasone 17-propionate. Plasma concentration was measured at the following timepoints: pre-dose, 30 min, 1, 2, 3, 5 and 7 hours post-dose

Secondary Outcome Measures

1. Number of Subjects With Hypothalamic-pituitary-adrenal [HPA] Suppression After 4 Weeks of Treatment [Week 4]

   The HPA axis evaluation is based on an Adrenocorticotropic hormone [ACTH] challenge test, defined by a 30 minutes ACTH stimulated cortisol value. Only subject with no HPA suppression at baseline were included in the analysis. The outcome measure lists the number of subjects with HPA suppression 30 minutes after ACTH challenge

2. Number of Subjects With Hypothalamic-pituitary-adrenal [HPA] Suppression After 8 Weeks of Treatment [Week 8]

   The HPA challenge test were only performed on subjects that were assigned to the MC2-01 cream group. Out of a total of 32 subjects, 5 subjects were excluded from the analysis as they had HPA suppression at baseline

3. Calcium Metabolism Evaluation in Albumin-corrected Serum Calcium [Baseline and week 4]

   Changes from baseline of albumin-corrected serum calcium [mmol/L]

4. Calcium Metabolism Evaluation in Albumin-corrected Serum Calcium [Baseline and week 8]

   Changes from baseline in albumin-corrected serum calcium [mmol/L]

5. Calcium Metabolism Evaluation of 24-hour Urinary Calcium Excretion [Baseline and week 4]

   Changes from baseline of 24-hour urinary calcium excretion [mmol/day]

6. Calcium Metabolism Evaluation of 24-hour Urinary Calcium Excretion [Baseline and week 8]

   Changes from baseline of 24-hour urinary calcium excretion [mmol/day]

7. Calcium Metabolism Evaluation of the Ratio of Urinary Calcium to Creatinine [Baseline and week 4]

   Changes from baseline in ratio of urinary calcium to creatinine defined as urinary calcium (mmol)/creatinine (g)

8. Calcium Metabolism Evaluation of the Ratio of Urinary Calcium to Creatinine [Baseline and week 8]

   Changes from baseline in ratio of urinary calcium to creatinine defined as urinary calcium (mmol)/creatinine (g)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Have provided written informed consent.

• Generally healthy males or non-pregnant females, of any race or ethnicity, who are at least 18 years of age at the time of screening.

• At Visit 1/Day 0, have a clinical diagnosis of plaque psoriasis (psoriasis vulgaris) of at least 6 months duration involving scalp and body (trunk and/or limbs) that is amenable to topical treatment with a maximum of 100 g of trial medication per week.

• Have a Physician's Global Assessment [PGA] of severity of at least moderate on the trunk, limbs and/or scalp, at Visit 1/Day 0.

• Have a treatment area between 20% and 30% of the body surface area [BSA] on the trunk, limbs and/or scalp, excluding psoriatic lesions on the face, genitals, and intertriginous areas, at Visit 1/Day 0.

Exclusion Criteria:

• Current diagnosis of unstable forms of psoriasis

• Other inflammatory skin disease in the treatment area

• Pigmentation, extensive scarring, pigmented lesions or sunburn in the treatment areas

• Planned exposure to natural or artificial sunlight

• Phototherapy and ultraviolet B radiation within 4 weeks prior to Visit 1/Baseline and during the trial;

• Current or past history of hypercalcemia, vitamin D toxicity, severe renal insufficiency, or severe hepatic disorders;

• Oral calcium supplements, vitamin D supplements, bisphosphonates or calcitonin within 4 weeks prior to Visit 1/Day 0 during the trial period.

• Planned initiation of, or changes to concomitant medication that could affect calcium metabolism during the trial;

• Planned initiation of, or changes to, concomitant estrogen therapy during the trial;

• Strong systemic cytochrome P450 3A4 (CYP 3A4) inhibitors within 4 weeks prior to Vist 1/Day 0 and during the trial period;

• Use of topical treatments, except for emollients and non-medicated shampoos, with a possible effect on psoriasis within 2 weeks prior to Visit 1/Day 0 and during the trial period;

• Systemic treatment with biological therapies

• Initiation of, or expected changes to, concomitant medication that may affect psoriasis during the trial period;

• Depression and endocrine disorders known to affect cortisol levels or HPA axis integrity, non-nocturnal sleep patterns

• Systemic medication that suppresses the immune system within 4 weeks prior to the Visit 1/Day 0 and during the trial period;

• Clinical signs of skin infection with bacteria, viruses, or fungi;

• Known human immunodeficiency virus [HIV] infection;

• Known or suspected of hypersensitivity to any component of the test product or reference product;

• Any chronic or acute medical condition that may pose a risk to the safety of the subject, or may interfere with the assessment of safety or efficacy in this trial;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lenus Research and Medical Group	Sweetwater	Florida	United States	33172

Sponsors and Collaborators

• MC2 Therapeutics

Investigators

• Principal Investigator: George Han, Department of Dermatology, Mount Sinai Beth Israel

Study Documents (Full-Text)

• Study Protocol - Dec 20, 2017
• Statistical Analysis Plan - Sep 21, 2018

More Information

Publications

None provided.

• Responsible Party: MC2 Therapeutics
• ClinicalTrials.gov Identifier: NCT03462927
• Other Study ID Numbers: MC2-01-C3
• First Posted: Mar 13, 2018
• Last Update Posted: Dec 24, 2019
• Last Verified: Dec 1, 2019

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Psoriasis

Study Results

Participant Flow

Recruitment Details	First Subject First Visit: 08Feb-2018. Last Subject Last Visit: 04-Aug-2018.
Pre-assignment Detail	Prior to randomization, the subject entered a washout period (if required) where anti-psoriatic treatment and other relevant medication/treatments were discontinued as defined by the exclusion criteria. The washout/screening period lasted for up to 4 weeks depending on which disallowed treatments the subject received.

Arm/Group Title	MC2-01 Cream	CAL/BDP Combination
Arm/Group Description	MC2-01 cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/ 0.064%). One application daily for 8 weeks. MC2-01 Cream: MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%)	CAL/BDP ointment (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%, w/w 0.005%/0.064%). One daily application for 4 weeks. CAL/BDP combination: Calcipotriene/betamethasone (calcipotriene/ betamethasone dipropionate, w/w 0.005%/0.064%)
Period Title: Overall Study
STARTED	32	31
COMPLETED	26	29
NOT COMPLETED	6	2

Baseline Characteristics

Arm/Group Title	MC2-01 Cream	CAL/BDP Combination	Total
Arm/Group Description	MC2-01 cream (CAL and BDP, w/w 0.005%/ 0.064%). MC2-01 Cream: MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%)	CAL/BDP ointment (w/w 0.005%/0.064%). CAL/BDP combination: Calcipotriene/betamethasone (calcipotriene/ betamethasone dipropionate, w/w 0.005%/0.064%)	Total of all reporting groups
Overall Participants	32	31	63
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	52.8 (15.5)	49.7 (16.2)	51.3 (15.8)
Sex: Female, Male (Count of Participants)
Female	19 59.4%	21 67.7%	40 63.5%
Male	13 40.6%	10 32.3%	23 36.5%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 3.1%	0 0%	1 1.6%
Asian	1 3.1%	1 3.2%	2 3.2%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	2 6.3%	2 6.5%	4 6.3%
White	28 87.5%	28 90.3%	56 88.9%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	32 100%	31 100%	63 100%
Baseline Physician's Global Assessment (PGA) (Count of Participants)
Moderate	29 90.6%	30 96.8%	59 93.7%
Severe	3 9.4%	1 3.2%	4 6.3%
Baseline Body Surface Area (BSA) (Percentage of psoriasis involvement) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Percentage of psoriasis involvement]	23.56 (2.52)	24.09 (3.13)	23.82 (2.82)
Fitzpatrick Skin Type (Count of Participants)
I	3 9.4%	2 6.5%	5 7.9%
II	11 34.4%	9 29%	20 31.7%
III	8 25%	6 19.4%	14 22.2%
IV	5 15.6%	9 29%	14 22.2%
V	3 9.4%	5 16.1%	8 12.7%
VI	2 6.3%	0 0%	2 3.2%

Outcome Measures

1. Primary Outcome

Title	Maximum Plasma Concentration (Cmax) of the Active Ingredient Calcipotriene
Description	Geometric Mean for Maximum Plasma Concentration [Cmax] for the active ingredient Calcipotriene. Plasma concentration was measured at the following timepoints: pre-dose, 30 min, 1, 2, 3, 5 and 7 hours post-dose
Time Frame	Week 4

Outcome Measure Data

Analysis Population Description

9 subjects were excluded from the PK evaluation at Week 4: 5 in the MC2-01 cream group and 4 in the active comparator group

Arm/Group Title	MC2-01 Cream	CAL/BDP Ointment
Arm/Group Description	MC2-01 cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%).	CAL/BDP ointment: Calcipotriene/betamethasone (calcipotriene/ betamethasone dipropionate, w/w 0.005%/0.064%)
Measure Participants	27	27
Geometric Mean (95% Confidence Interval) [pg/mL]	30.2	30.0

2. Primary Outcome

Title	Maximum Plasma Concentration (Cmax) of the Active Ingredient Calcipotriene
Description	Geometric Mean for Maximum Plasma Concentration [Cmax] for the active ingredient Calcipotriene. Plasma concentration was measured at the following timepoints: pre-dose, 30 min, 1, 2, 3, 5 and 7 hours post-dose
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

As per protocol, only subjects assigned to the MC2-01 cream had samples for PK testing collected at week 8. Only subjects that had a computable value of the PK parameter have been included in the analysis

Arm/Group Title	MC2-01 Cream
Arm/Group Description	MC2-01 cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%).
Measure Participants	19
Geometric Mean (95% Confidence Interval) [pg/mL]	30.0

3. Primary Outcome

Title	Maximum Plasma Concentration (Cmax) of Active Ingredient Betamethasone Dipropionate
Description	Geometric Mean for Maximum Plasma Concentration [Cmax] for the active ingredient Betamethasone Dipropionate. Plasma concentration was measured at the following timepoints: pre-dose, 30 min, 1, 2, 3, 5 and 7 hours post-dose
Time Frame	Week 4

Outcome Measure Data

Analysis Population Description

9 subjects were excluded from the PK evaluation at Week 4: 5 in the MC2-01 cream group and 4 in the active comparator group

Arm/Group Title	MC2-01 Cream	CAL/BDP Combination
Arm/Group Description	MC2-01 cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%)	CAL/BDP ointment: Calcipotriene/betamethasone (calcipotriene/ betamethasone dipropionate, w/w 0.005%/0.064%)
Measure Participants	27	27
Geometric Mean (95% Confidence Interval) [pg/mL]	21.5	23.1

4. Primary Outcome

Title	Maximum Plasma Concentration (Cmax) of Active Ingredient Betamethasone Dipropionate
Description	Geometric Mean for Maximum Plasma Concentration [Cmax] for the active ingredient Betamethasone Dipropionate. Plasma concentration was measured at the following timepoints: pre-dose, 30 min, 1, 2, 3, 5 and 7 hours post-dose
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

As per protocol, only subjects assigned to the MC2-01 cream had samples for PK testing collected at week 8. Only subjects that had a computable value of the PK parameter have been included in the analysis

Arm/Group Title	MC2-01 Cream
Arm/Group Description	MC2-01 cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%).
Measure Participants	19
Geometric Mean (95% Confidence Interval) [pg/mL]	20.0

5. Primary Outcome

Title	Maximum Plasma Concentration (Cmax) of the Metabolite MC1080
Description	Geometric Mean for Maximum Plasma Concentration [Cmax] for the metabolite MC1080. Plasma concentration was measured at the following timepoints: pre-dose, 30 min, 1, 2, 3, 5 and 7 hours post-dose
Time Frame	Week 4

Outcome Measure Data

Analysis Population Description

9 subjects were excluded from the PK evaluation at Week 4: 5 in the MC2-01 cream group and 4 in active comparator group

Arm/Group Title	MC2-01 Cream	CAL/BDP Ointment
Arm/Group Description	MC2-01 cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%).	CAL/BDP ointment: Calcipotriene/betamethasone (calcipotriene/ betamethasone dipropionate, w/w 0.005%/0.064%)
Measure Participants	27	27
Geometric Mean (95% Confidence Interval) [pg/mL]	29.8	29.2

6. Primary Outcome

Title	Maximum Plasma Concentration (Cmax) of the Metabolite MC1080
Description	Geometric Mean for Maximum Plasma Concentration [Cmax] for the metabolite MC1080. Plasma concentration was measured at the following timepoints: pre-dose, 30 min, 1, 2, 3, 5 and 7 hours post-dose
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

As per protocol, only subjects assigned to the MC2-01 cream had samples for PK testing collected at week 8. Only subjects that had a computable value of the PK parameter have been included in the analysis

Arm/Group Title	MC2-01 Cream
Arm/Group Description	MC2-01 cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%).
Measure Participants	19
Geometric Mean (95% Confidence Interval) [pg/mL]	29.1

7. Primary Outcome

Title	Maximum Plasma Concentration (Cmax) of Metabolite Betamethasone 17-propionate
Description	Geometric Mean for Maximum Plasma Concentration [Cmax] for the metabolite Betamethasone 17-propionate. Plasma concentration was measured at the following timepoints: pre-dose, 30 min, 1, 2, 3, 5 and 7 hours post-dose
Time Frame	Week 4

Outcome Measure Data

Analysis Population Description

9 subjects were excluded from the PK evaluation at Week 4: 5 in the MC2-01 cream group and 4 in active comparator group

Arm/Group Title	MC2-01 Cream	CAL/BDP Ointment
Arm/Group Description	MC2-01 cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%).	CAL/BDP ointment: Calcipotriene/betamethasone (calcipotriene/ betamethasone dipropionate, w/w 0.005%/0.064%)
Measure Participants	27	27
Geometric Mean (95% Confidence Interval) [pg/mL]	39.3	38.2

8. Primary Outcome

Title	Maximum Plasma Concentration (Cmax) of Metabolite Betamethasone 17-propionate
Description	Geometric Mean for Maximum Plasma Concentration [Cmax] for the metabolite Betamethasone 17-propionate. Plasma concentration was measured at the following timepoints: pre-dose, 30 min, 1, 2, 3, 5 and 7 hours post-dose
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

As per protocol, only subjects assigned to the MC2-01 cream had samples for PK testing collected at week 8. Only subjects that had a computable value of the PK parameter have been included in the analysis

Arm/Group Title	MC2-01 Cream
Arm/Group Description	MC2-01 cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%).
Measure Participants	19
Geometric Mean (95% Confidence Interval) [pg/mL]	26.2

9. Secondary Outcome

Title	Number of Subjects With Hypothalamic-pituitary-adrenal [HPA] Suppression After 4 Weeks of Treatment
Description	The HPA axis evaluation is based on an Adrenocorticotropic hormone [ACTH] challenge test, defined by a 30 minutes ACTH stimulated cortisol value. Only subject with no HPA suppression at baseline were included in the analysis. The outcome measure lists the number of subjects with HPA suppression 30 minutes after ACTH challenge
Time Frame	Week 4

Outcome Measure Data

Analysis Population Description

The HPA challenge test were only performed on subjects that were assigned to the MC2-01 cream group. No data were collected from the CAL/BDP Ointment group. Out of a total of 32 subjects, 5 subjects were excluded from the analysis as they had HPA suppression at baseline

Arm/Group Title	MC2-01 Cream
Arm/Group Description	MC2-01 cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%).
Measure Participants	27
Count of Participants [Participants]	1 3.1%

10. Secondary Outcome

Title	Number of Subjects With Hypothalamic-pituitary-adrenal [HPA] Suppression After 8 Weeks of Treatment
Description	The HPA challenge test were only performed on subjects that were assigned to the MC2-01 cream group. Out of a total of 32 subjects, 5 subjects were excluded from the analysis as they had HPA suppression at baseline
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

The HPA challenge test were only performed on subjects that were assigned to the MC2-01 cream group. No data were collected from the CAL/BDP Ointment group. Out of a total of 32 subjects, 6 subjects were excluded from the analysis; 5 as they had HPA suppression at baseline and 1 who withdrew consent

Arm/Group Title	MC2-01 Cream
Arm/Group Description	MC2-01 cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%).
Measure Participants	26
Count of Participants [Participants]	2 6.3%

11. Secondary Outcome

Title	Calcium Metabolism Evaluation in Albumin-corrected Serum Calcium
Description	Changes from baseline of albumin-corrected serum calcium [mmol/L]
Time Frame	Baseline and week 4

Outcome Measure Data

Analysis Population Description

As per protocol, only subjects assigned to the MC2-01 cream were included in the calcium metabolism evaluation. No data were collected from the CAL/BDP Ointment group. 5 subjects in the MC2-01 cream group were excluded from the analysis

Arm/Group Title	MC2-01 Cream
Arm/Group Description	MC2-01 cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%).
Measure Participants	27
Mean (Standard Deviation) [mmol/L]	-0.00 (0.09)

12. Secondary Outcome

Title	Calcium Metabolism Evaluation in Albumin-corrected Serum Calcium
Description	Changes from baseline in albumin-corrected serum calcium [mmol/L]
Time Frame	Baseline and week 8

Outcome Measure Data

Analysis Population Description

As per protocol, only subjects assigned to the MC2-01 cream were included in the calcium metabolism evaluation. No data were collected from the CAL/BDP Ointment group. 6 subjects in the MC2-01 cream group were excluded from the analysis

Arm/Group Title	MC2-01 Cream
Arm/Group Description	MC2-01 cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%).
Measure Participants	26
Mean (Standard Deviation) [mmol/L]	0.00 (0.07)

13. Secondary Outcome

Title	Calcium Metabolism Evaluation of 24-hour Urinary Calcium Excretion
Description	Changes from baseline of 24-hour urinary calcium excretion [mmol/day]
Time Frame	Baseline and week 4

Outcome Measure Data

Analysis Population Description

As per protocol, only subjects assigned to the MC2-01 cream were included in the calcium metabolism evaluation. No data were collected from the CAL/BDP Ointment group. 8 subjects in the MC2-01 cream group were excluded from the analysis

Arm/Group Title	MC2-01 Cream
Arm/Group Description	MC2-01 cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%).
Measure Participants	24
Mean (Standard Deviation) [mmol/day]	-0.56 (1.69)

14. Secondary Outcome

Title	Calcium Metabolism Evaluation of 24-hour Urinary Calcium Excretion
Description	Changes from baseline of 24-hour urinary calcium excretion [mmol/day]
Time Frame	Baseline and week 8

Outcome Measure Data

Analysis Population Description

As per protocol, only subjects assigned to the MC2-01 cream were included in the calcium metabolism evaluation. No data were collected from the CAL/BDP Ointment group. 12 subjects in the MC2-01 cream group were excluded from the analysis

Arm/Group Title	MC2-01 Cream
Arm/Group Description	MC2-01 cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%).
Measure Participants	20
Mean (Standard Deviation) [mmol/day]	-0.45 (1.08)

15. Secondary Outcome

Title	Calcium Metabolism Evaluation of the Ratio of Urinary Calcium to Creatinine
Description	Changes from baseline in ratio of urinary calcium to creatinine defined as urinary calcium (mmol)/creatinine (g)
Time Frame	Baseline and week 4

Outcome Measure Data

Analysis Population Description

As per protocol, only subjects assigned to the MC2-01 cream were included in the calcium metabolism evaluation. No data were collected from the CAL/BDP Ointment group. 8 subjects in the MC2-01 cream group were excluded from the analysis

Arm/Group Title	MC2-01 Cream
Arm/Group Description	MC2-01 cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%).
Measure Participants	24
Mean (Standard Deviation) [mmol/g]	-0.23 (1.49)

16. Secondary Outcome

Title	Calcium Metabolism Evaluation of the Ratio of Urinary Calcium to Creatinine
Description	Changes from baseline in ratio of urinary calcium to creatinine defined as urinary calcium (mmol)/creatinine (g)
Time Frame	Baseline and week 8

Outcome Measure Data

Analysis Population Description

As per protocol, only subjects assigned to the MC2-01 cream were included in the calcium metabolism evaluation. No data were collected from the CAL/BDP Ointment group. 12 subjects in the MC2-01 cream group were excluded from the analysis

Arm/Group Title	MC2-01 Cream
Arm/Group Description	MC2-01 cream (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%).
Measure Participants	20
Mean (Standard Deviation) [mmol/g]	0.00 (1.32)

Adverse Events

Time Frame	AEs were collected/assessed from the time of the signature of the informed consent form by the subject during the screening visit (up to 4 weeks prior to treatment), during the treatment period (up to 8 weeks) and until the final follow-up visit had occurred (up to 4 weeks following end of treatment). All AEs that were considered related to the trial product would be followed until they were resolved, or until the medical condition of the subject was stable
Arm/Group Title	MC2-01 Cream		CAL/BDP Combination
Arm/Group Description	MC2-01 cream (CAL and BDP, w/w 0.005%/ 0.064%). MC2-01 Cream: MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%)		CAL/BDP ointment (w/w 0.005%/0.064%). CAL/BDP combination: Calcipotriene/betamethasone (calcipotriene/ betamethasone dipropionate, w/w 0.005%/0.064%)
All Cause Mortality
	MC2-01 Cream		CAL/BDP Combination
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/32 (0%)		0/31 (0%)
Serious Adverse Events
	MC2-01 Cream		CAL/BDP Combination
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/32 (0%)		1/31 (3.2%)
Musculoskeletal and connective tissue disorders
Ankle Fracture	0/32 (0%)	0	1/31 (3.2%)	1
Other (Not Including Serious) Adverse Events
	MC2-01 Cream		CAL/BDP Combination
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/32 (0%)		0/31 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.