Acne VulgarisPhase 2NCT02720627

An Evaluation of the Adrenal Suppression Potential and PK of CB-03-01 Cream in Pediatric Patients With Acne Vulgaris

A Phase 2 study testing cortexolone 17α-propionate in people with Acne Vulgaris, run by Cassiopea SpA at 10 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 9 to 11 years
Conditions the study is for: Acne Vulgaris
What is being tested?: cortexolone 17α-propionate
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 27 participants
Where: 10 sitesin 2 countries
Study dates: 28 Oct 2016to 21 Mar 2018
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 9 to 11 years
All sexes
No healthy volunteers
Child

Who may be able to join

Patient must provide written informed assent and be accompanied by the parent or legal guardian at the time of assent/consent signing. The parent or legal guardian must provide written informed consent for the patient.
Patient has moderate to severe facial acne vulgaris as determined by the Investigator and obvious acne on the trunk (i.e., shoulders, upper chest, and/or back).
Females of childbearing potential must be using highly effective birth control methods with a negative urine pregnancy test (UPT) at study start.
Patient must be in general good health with normal renal function and no clinically relevant abnormalities present at study start.
Patient and parent/guardian are able to communicate with the staff and are willing to comply with study instructions, reside at and/or return to the clinic for required visits.

Who cannot join

Patient is pregnant, lactating, or is planning to become pregnant during the study.
Patient has a Body Mass Index (BMI) for age percentile > 95%.
Patient has any skin or medical condition, including facial hair that could interfere with the evaluation of the test article or requires the use of interfering topical or systemic therapy.
Patient has received an investigational drug or been treated with an investigational device within 30 days prior to study start.
Patient is currently enrolled in an investigational drug or device study.
Patient has any condition which, in the investigator's opinion, would make it unsafe for the patient to participate in this research study.
Patient has known allergy or sensitivity to CB-03-01 or any of its ingredients
Patient has participated in a previous CB-03-01 study.

Trial locations and contacts

10 sites in 2 countries.

Country

City, postcode or hospital

10 sites in 2 countries

Poland7 sites

Site 4814
Częstochowa
Site 4811
Katowice
Site 4813
Krakow
Site 4815
Krakow
Site 4816
Rzeszów
Site 4812
Szczecin
Site 4817
Tarnów

Other trials in Poland

United States3 sites

Site 103
Fort Smith, Arkansas, 72916
Site 102
Houston, Texas, 77030
Site 101
San Diego, California, 92037

Other trials in United States

About this study

Official title: An Open Label Evaluation of the Adrenal Suppression Potential and Trough Plasma Concentrations of Cortexolone 17α-Propionate (CB-03-01) Cream Applied Every 12 Hours for Two Weeks in Subjects 9 to <12 Years of Age With Acne Vulgaris

This study is designed to determine the hypothalamic-pituitary-adrenal (HPA) axis suppression potential and pharmacokinetic (PK) properties of CB-03-01 Cream, 1%, applied every twelve hours for two weeks, in pediatric patients 9 to less than 12 years of age with acne vulgaris. Adrenal suppression effects and systemic safety are an important safety concern. The current study is designed to investigate these potential concerns under maximal use conditions.

Conditions: Acne Vulgaris
Being tested: cortexolone 17α-propionate
Keywords: acne, cortexolone, anti-androgen
Medical subject headings: Acne Vulgaris

What participants receive

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

cortexolone 17α-propionateDrug
Also called CB-03-01
CB-03-01 cream is a topical steroidal antiandrogen that is being developed for the potential treatment of acne vulgaris, an androgen-dependent skin disorder.

Study groups in NCT02720627
Study group	Role	What they receive
CB-03-01 cream, 1%	Experimental	Topical CB-03-01 (cortexolone 17α-propionate) cream containing 1% active drug applied to the face and trunk twice daily for 14 days Receives: Drug: cortexolone 17α-propionate

What is being measured

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

Change in HPA Axis Response as Measured by CST
Measurement of serum cortisol concentrations after stimulation of the adrenal cortex with cosyntropin (Cosyntropin Stimulation Test - CST). HPA axis suppression is defined as a post-stimulation serum cortisol level ≤ 18 μg/dL at Day 14.
Measured: Pre- and Post-CST on Day 14

Secondary outcomes (1)

Evaluate Trough Plasma Concentrations
Trough (single blood draw approximately 12 hours post the most recent dose) measurements of cortexolone 17α-propionate (clascoterone) concentration in plasma at Screening, Baseline, Day 7 and Day 14.
Measured: 14 Days

Timeline

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

28 Oct 201621 Mar 2018

First posted28 Mar 2016 (estimated)
Study start28 Oct 2016
Primary completion21 Mar 2018
Study completion21 Mar 2018

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 Acne 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: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02720627
Sponsor's protocol ID: CB-03-01/28
Status last verified: Nov 2020
First submitted: 22 Mar 2016
Last updated: 20 Nov 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: 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

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All Acne Vulgaris trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Label Evaluation of the Adrenal Suppression Potential and Trough Plasma Concentrations of Cortexolone 17α-Propionate (CB-03-01) Cream Applied Every 12 Hours for Two Weeks in Subjects 9 to <12 Years of Age With Acne Vulgaris
ClinicalTrials.gov ID: NCT02720627
Acronym / sponsor ID: CB-03-01/28
Conditions: Acne Vulgaris
Keywords: acne, cortexolone, anti-androgen
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 27 participants (actual)
Lead sponsor: Cassiopea SpAIndustry (pharma, biotech, devices)
Study start: 28 Oct 2016 (actual)
Primary completion: 21 Mar 2018 (actual)
Study completion: 21 Mar 2018 (actual)
First posted: 28 Mar 2016 (estimated)
Results: Posted 19 Oct 2020

Clinical summary

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

Study design

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

Arm	Type	Receives
CB-03-01 cream, 1%	Experimental	Drug: cortexolone 17α-propionateTopical CB-03-01 (cortexolone 17α-propionate) cream containing 1% active drug applied to the face and trunk twice daily for 14 days

Who may qualify

Ages: 9 to 11 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (5 listed)

Patient must provide written informed assent and be accompanied by the parent or legal guardian at the time of assent/consent signing. The parent or legal guardian must provide written informed consent for the patient.
Patient has moderate to severe facial acne vulgaris as determined by the Investigator and obvious acne on the trunk (i.e., shoulders, upper chest, and/or back).
Females of childbearing potential must be using highly effective birth control methods with a negative urine pregnancy test (UPT) at study start.
Patient must be in general good health with normal renal function and no clinically relevant abnormalities present at study start.
Patient and parent/guardian are able to communicate with the staff and are willing to comply with study instructions, reside at and/or return to the clinic for required visits.

Key exclusion criteria (8 listed)

Patient is pregnant, lactating, or is planning to become pregnant during the study.
Patient has a Body Mass Index (BMI) for age percentile > 95%.
Patient has any skin or medical condition, including facial hair that could interfere with the evaluation of the test article or requires the use of interfering topical or systemic therapy.
Patient has received an investigational drug or been treated with an investigational device within 30 days prior to study start.
Patient is currently enrolled in an investigational drug or device study.

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
cortexolone 17α-propionateAlso: CB-03-01CB-03-01 cream is a topical steroidal antiandrogen that is being developed for the potential treatment of acne vulgaris, an androgen-dependent skin disorder.	Drug	CB-03-01 cream, 1%

Primary outcome

Change in HPA Axis Response as Measured by CST
Time frame: Pre- and Post-CST on Day 14
Measurement of serum cortisol concentrations after stimulation of the adrenal cortex with cosyntropin (Cosyntropin Stimulation Test - CST). HPA axis suppression is defined as a post-stimulation serum cortisol level ≤ 18 μg/dL at Day 14.

1 secondary outcome

Evaluate Trough Plasma Concentrations
Time frame: 14 Days

Results and safety

Results posted to the registry on 19 Oct 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CB-03-01 Cream, 1%	27	27

Primary outcome: Change in HPA Axis Response as Measured by CST

Time frame: Pre- and Post-CST on Day 14. Mean (Standard Deviation). Unit: mcg/dL

Measure	CB-03-01 Cream, 1% n = 23
Cortisol level (Pre-CST)	12.50 (4.90)
Cortisol level (Post-CST)	22.95 (3.20)

Population analysed: Evaluable population, defined as all subjects in the safety population who had evaluable cortisol assay data.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 14 Days or up to 42 days for those with laboratory evidence of adrenal suppression (i.e., post-stimulation serum cortisol level ≤18 μg/dL at Day 14).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CB-03-01 Cream, 1%	0 of 27 (0%)	5 of 27 (18.5%)	0 of 27

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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.

R&D Department study director

Cassiopea SpA

10 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 cortexolone 17α-propionate in people with Acne Vulgaris, run by Cassiopea SpA at 10 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 5 inclusion and 8 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: finished, as of the sponsor's last update on 20 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Poland, United States. 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 19 Oct 2020). 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?

Change in HPA Axis Response as Measured by CST (time frame: Pre- and Post-CST on Day 14). 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 NCT02720627.

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 20 Nov 2020.