Psoriasis VulgarisPhase 2NCT03819218

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

A Phase 2 study testing MC2-01 cream in people with Psoriasis Vulgaris, run by MC2 Therapeutics at 2 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This is a phase 2, open-label, single-group, multicentre trial in which the investigational product, MC2-01 cream, is investigated in adolescent subjects (age 12 to 16 years, 11 months) with clinically diagnosed extensive psoriasis vulgaris. Read more about this study

Who is it for?: Ages 12 to 16 years
Conditions the study is for: Psoriasis Vulgaris
What is being tested?: MC2-01 cream
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 7 participants
Where: 2 sitesin 2 countries
Study dates: 27 Dec 2018to 11 Dec 2020
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 to 16 years
All sexes
No healthy volunteers
Child

Who may be able to join

The parent(s), or legal guardian(s) (according to national law) have provided written informed consent following their receipt of verbal and written information about the trial
The subject (according to national law) has provided written assent to the trial following their receipt of verbal and written information about the trial
Generally healthy males or non-pregnant females, of any race or ethnicity, who are between 12 to 16 years, 11-month-old at Screening Visit 1 (SV1)
At Visit 1/Day 0, have a clinical diagnosis of plaque psoriasis (psoriasis vulgaris) of at least 6 months duration involving body (trunk and/or limbs), with or without scalp
Have a treatment area between 10% and 30% of the Body Surface Area (BSA) on the body (trunk and/or limbs) and scalp, excluding psoriatic lesions on the face, genitals, and intertriginous areas, at Visit 1/Day 0
Have a Physician's Global Assessment (PGA) of at least moderate severity on the treatment area
A normal HPA axis function including a serum cortisol concentration above 4,5 mcg/dl before ACTH-challenge and equal or above 18 mcg/dl 30 minutes after ACTH challenge, at Screening Visit 2 (SV2)
A serum albumin-corrected calcium below the upper reference limit at SV2

Who cannot join

Have a current diagnosis of unstable forms of psoriasis, including erythrodermic or pustular psoriasis
Other inflammatory skin disease in the treatment area that may confound the evaluation of the psoriasis vulgaris
Presence of infections in the treatment area or skin manifestations or atrophic skin, atrophic striae, skin vein fragility, ichthyosis, acne vulgaris, acne rosacea, rosacea, ulcers and wounds in the treatment area
Presence of pigmentation, extensive scarring, pigmented lesions or sunburn in the treatment areas, which could interfere with the rating of efficacy parameters
Planned excessive or prolonged exposure to either natural or artificial sunlight
Use of phototherapy (psoralen + ultraviolet A radiation and ultraviolet B radiation within 4 weeks prior to SV2 and during the trial

Show all 24Show fewer

Current or past history of disorders of calcium metabolism associated with 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 SV2
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 or inducers within 4 weeks prior to SV2 and during the trial
Use of topical treatments, except for emollients and non-medicated shampoos, with a possible effect on psoriasis within 2 weeks prior to SV2 and during the trial
Systemic treatment with biological therapies, with a possible effect on psoriasis vulgaris within the following time period prior to SV2 and during the trial
Initiation of, or expected changes to, concomitant medication that may affect psoriasis during the trial
Any of the following conditions, whether known or suspected; Clinically diagnosed depression where the subject is in current treatment with medication approved for treatment of depression; Endocrine disorders known to affect cortisol levels or HPA axis integrity; Non-nocturnal sleep patterns
Use of systemic medication that suppresses the immune system and other systemic chemotherapeutic antineoplastic therapy within 4 weeks prior to the SV2 and during the trial
Use of live vaccines 4 weeks before SV2 and during the trial
Have clinical signs of skin infection with bacteria, viruses, or fungi
Known human immunodeficiency virus (HIV) infection, active hepatitis B or hepatitis C
Known or suspected of hypersensitivity to any component of the test product
Known allergic asthma, serious allergies or allergies where recurrent acute or chronic treatment is necessary
Have any chronic or acute medical condition that, in the opinion of the investigator, may pose a risk to the safety of the subject, or may interfere with the assessment of safety or efficacy in this trial
Require the use of any concomitant medication that, in the investigator's opinion, has the potential to cause an adverse effect when given with the Investigational Product (IP) or will interfere with the interpretation of the trial results
Subject with known abnormal reduction in muscle mass, as judged by the investigator

Trial locations and contacts

2 sites in 2 countries.

Country

City, postcode or hospital

2 sites in 2 countries

Czechia1 site

PRO SANUM a.s.
Prague, 110 00

Other trials in Czechia

Germany1 site

Dept. of Dermatology, Venereology and Allergology
Frankfurt, Frankfurt/Main, 60590

Other trials in Germany

About this study

Official title: A Multicentre, Open-label, Single-group Maximal Use Trial, Evaluating the Safety and Pharmacokinetic Profile of the Active Ingredients and Their Metabolites After Application of MC2-01 Cream in Adolescents With Extensive Psoriasis Vulgaris

Read the 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, subjects who fulfil all inclusion and exclusion criteria are enrolled in the trial and will apply one dose of trial medication topically once daily for 8 weeks. The purpose of the trial, is to determine the and pharmacokinetic parameters of MC2-01 cream in adolescent subjects under maximum use conditions.

Conditions: Psoriasis Vulgaris
Being tested: MC2-01 cream

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MC2-01 creamDrug
MC2-01 cream (Calcipotriene/betamethasone dipropionate, w/w 0.005%/ 0.064%)

Study groups in NCT03819218
Study group	Role	What they receive
MC2-01 cream	Experimental	MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream. One application daily for 8 weeks Receives: Drug: MC2-01 cream

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With HPA (Hypothalamic-pituitary-adrenal) Axis Suppression at Week 4
Adrenal function will be assessed in a challenge test with an intravenous dose of cosyntropin. Measurement of serum cortisol levels pre- and post- stimulation is an accepted standard method used to evaluate adrenal suppression.
The test consists of an initial blood sampling. Following the blood sample, an intravenous bolus injection of 0.25 mg cosyntropin is given. The serum cortisol concentration 30 min. after will reflect stimulation of the adrenal glands induced by cosyntropin. HPA axis suppression is define as serum cortisol below 18 µg/dL
Measured: Week 4
Number of Participants With HPA (Hypothalamic-pituitary-adrenal) Axis Suppression at Week 8
Adrenal function will be assessed in a challenge test with an intravenous dose of cosyntropin. Measurement of serum cortisol levels pre- and post- stimulation is an accepted standard method used to evaluate adrenal suppression.
The test consists of an initial blood sampling. Following the blood sample, an intravenous bolus injection of 0.25 mg cosyntropin is given. The serum cortisol concentration 30 min. after will reflect stimulation of the adrenal glands induced by cosyntropin. HPA axis suppression is define as serum cortisol below 18 µg/dL
Measured: Week 8
Change in S-Calcium Metabolism at Week 4
Change from Baseline to Week 4 in albumin-corrected S-calcium
Measured: Week 4
Change in S-Calcium Metabolism at Week 8
Change from Baseline to Week 8 in albumin-corrected S-calcium
Measured: Week 8
Change in U-Calcium Metabolism at Week 4
Change from Baseline to Week 4 in Urinary Calcium/Creatinine ratio (mol/mol)
Measured: Week 4
Change in U-Calcium Metabolism at Week 8
Change from Baseline to Week 8 in Urinary Calcium/Creatinine ratio (mol/mol)
Measured: Week 8

Secondary outcomes (2)

The Maximum Plasma Concentration [Cmax] of Betamethasone 17-propionate at Week 4
The Maximum Plasma Concentration [Cmax] of the metabolite of BDP, betamethasone 17-propionate measured at Week 4.
Measured: Week 4
Time to Maximum Plasma Drug Concentration [Tmax] of Betamethasone 17-propionate at Week 4
Time to maximum plasma drug concentration [Tmax] of the metabolite of BDP, betamethasone 17-propionate measured at Week 4.
Measured: Week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Dec 201811 Dec 2020

First posted28 Jan 2019
Study start27 Dec 2018
Primary completion11 Dec 2020
Study completion11 Dec 2020

Why it stopped: Lack of recruitment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Psoriasis VulgarisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 7 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03819218
Sponsor's protocol ID: MC2-01-C6
Status last verified: Feb 2021
First submitted: 11 Jan 2019
Last updated: 19 Mar 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 4
Residual Disease MEMory in PSOriasis Skin During EnstiLAR® and Narrow-band Ultraviolet B Therapy: The MEMPSOLAR Study
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RecruitingObservational study
Collection of Samples From Subjects With Various Skin Conditions and Healthy Volunteers
Acne, Atopic Dermatitis
RecruitingPhase 4
Topical Diacerein in Psoriasis Vulgaris
Psoriasis Vulgaris
Not yet recruiting
Ceramol PSOR Cream as an Adjuvant Treatment in Patients With Mild-to-Moderate Psoriasis Treated With Narrowband UVB Phototherapy (CERAMOL PSOR CREMA)
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RecruitingPhase 1
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All Psoriasis Vulgaris trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicentre, Open-label, Single-group Maximal Use Trial, Evaluating the Safety and Pharmacokinetic Profile of the Active Ingredients and Their Metabolites After Application of MC2-01 Cream in Adolescents With Extensive Psoriasis Vulgaris
ClinicalTrials.gov ID: NCT03819218
Acronym / sponsor ID: MC2-01-C6
Conditions: Psoriasis Vulgaris
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Lack of recruitment
Enrolment: 7 participants (actual)
Lead sponsor: MC2 TherapeuticsIndustry (pharma, biotech, devices)
Study start: 27 Dec 2018 (actual)
Primary completion: 11 Dec 2020 (actual)
Study completion: 11 Dec 2020 (actual)
First posted: 28 Jan 2019 (actual)
Results: Posted 21 Feb 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
MC2-01 cream	Experimental	Drug: MC2-01 creamMC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream. One application daily for 8 weeks

Who may qualify

Ages: 12 to 16 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (8 listed)

The parent(s), or legal guardian(s) (according to national law) have provided written informed consent following their receipt of verbal and written information about the trial
The subject (according to national law) has provided written assent to the trial following their receipt of verbal and written information about the trial
Generally healthy males or non-pregnant females, of any race or ethnicity, who are between 12 to 16 years, 11-month-old at Screening Visit 1 (SV1)
At Visit 1/Day 0, have a clinical diagnosis of plaque psoriasis (psoriasis vulgaris) of at least 6 months duration involving body (trunk and/or limbs), with or without scalp
Have a treatment area between 10% and 30% of the Body Surface Area (BSA) on the body (trunk and/or limbs) and scalp, excluding psoriatic lesions on the face, genitals, and intertriginous areas, at Visit 1/Day 0

Key exclusion criteria (24 listed)

Have a current diagnosis of unstable forms of psoriasis, including erythrodermic or pustular psoriasis
Other inflammatory skin disease in the treatment area that may confound the evaluation of the psoriasis vulgaris
Presence of infections in the treatment area or skin manifestations or atrophic skin, atrophic striae, skin vein fragility, ichthyosis, acne vulgaris, acne rosacea, rosacea, ulcers and wounds in the treatment area
Presence of pigmentation, extensive scarring, pigmented lesions or sunburn in the treatment areas, which could interfere with the rating of efficacy parameters
Planned excessive or prolonged exposure to either natural or artificial sunlight

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MC2-01 creamMC2-01 cream (Calcipotriene/betamethasone dipropionate, w/w 0.005%/ 0.064%)	Drug	MC2-01 cream

Primary outcome

Number of Participants With HPA (Hypothalamic-pituitary-adrenal) Axis Suppression at Week 4
Time frame: Week 4
Adrenal function will be assessed in a challenge test with an intravenous dose of cosyntropin. Measurement of serum cortisol levels pre- and post- stimulation is an accepted standard method used to evaluate adrenal suppression. The test consists of an initial blood sampling. Following the blood sample, an intravenous bolus injection of 0.25 mg cosyntropin is given. The serum cortisol concentration 30 min. after will reflect stimulation of the adrenal glands induced by cosyntropin. HPA axis suppression is define as serum cortisol below 18 µg/dL
Number of Participants With HPA (Hypothalamic-pituitary-adrenal) Axis Suppression at Week 8
Time frame: Week 8
Adrenal function will be assessed in a challenge test with an intravenous dose of cosyntropin. Measurement of serum cortisol levels pre- and post- stimulation is an accepted standard method used to evaluate adrenal suppression. The test consists of an initial blood sampling. Following the blood sample, an intravenous bolus injection of 0.25 mg cosyntropin is given. The serum cortisol concentration 30 min. after will reflect stimulation of the adrenal glands induced by cosyntropin. HPA axis suppression is define as serum cortisol below 18 µg/dL
Change in S-Calcium Metabolism at Week 4
Time frame: Week 4
Change from Baseline to Week 4 in albumin-corrected S-calcium
Change in S-Calcium Metabolism at Week 8
Time frame: Week 8
Change from Baseline to Week 8 in albumin-corrected S-calcium
Change in U-Calcium Metabolism at Week 4
Time frame: Week 4
Change from Baseline to Week 4 in Urinary Calcium/Creatinine ratio (mol/mol)
Change in U-Calcium Metabolism at Week 8
Time frame: Week 8
Change from Baseline to Week 8 in Urinary Calcium/Creatinine ratio (mol/mol)

2 secondary outcomes

The Maximum Plasma Concentration [Cmax] of Betamethasone 17-propionate at Week 4
Time frame: Week 4
Time to Maximum Plasma Drug Concentration [Tmax] of Betamethasone 17-propionate at Week 4
Time frame: Week 4

Results and safety

Results posted to the registry on 21 Feb 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MC2-01 Cream	7	6

Primary outcome: Number of Participants With HPA (Hypothalamic-pituitary-adrenal) Axis Suppression at Week 4

Time frame: Week 4. Count of participants. Unit: Participants

Measure	MC2-01 Cream n = 6
Value	0

Population analysed: The HPA population was defined as all subjects in the safety population that showed a normal HPA function at the screening visit.

Primary outcome: Number of Participants With HPA (Hypothalamic-pituitary-adrenal) Axis Suppression at Week 8

Time frame: Week 8. Count of participants. Unit: Participants

Measure	MC2-01 Cream n = 6
Value	0

Population analysed: The HPA population was defined as all subjects in the safety population that showed a normal HPA function at the screening visit.

Primary outcome: Change in S-Calcium Metabolism at Week 4

Time frame: Week 4. Mean (Standard Deviation). Unit: mmol/L

Measure	MC2-01 Cream n = 7
Value	-0.037 (0.084)

Population analysed: 7 subjects were included in the safety population at baseline and Week 4. At Week 8 1 subjects was withdrawn.

Primary outcome: Change in S-Calcium Metabolism at Week 8

Time frame: Week 8. Mean (Standard Deviation). Unit: mmol/L

Measure	MC2-01 Cream n = 7
Value	-0.027 (0.060)

Population analysed: 7 subjects were included in the safety population at baseline and Week 4. At Week 8 1 subjects was withdrawn.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: AEs were collected/assessed from the time of the signature of the informed consent form by the participant and until the final follow-up visit has occurred, i.e. up to in total up to 18 weeks, including a screening period of up to 6 weeks, a treatment period of 8 weeks and a follow-up period of 4 weeks. AEs that were considered related to the trial product would be followed until they were resolved, or until the medical condition of the participant was stable.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MC2-01 Cream	0 of 7 (0%)	3 of 7 (42.9%)	0 of 7

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Psoriasis Vulgaris

Active, not recruitingPhase 4
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Andreas Pinter, MD principal investigator

Dept. of Dermatology, Venereology and Allergology

2 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MC2-01 cream in people with Psoriasis Vulgaris, run by MC2 Therapeutics at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 19 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Czechia, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With HPA (Hypothalamic-pituitary-adrenal) Axis Suppression at Week 4 (time frame: Week 4). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03819218.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2021; AzTrials last refreshed its copy on 7 Nov 2026.