Acne VulgarisPhase 3NCT02608450

A Study to Evaluate the Safety and Efficacy of CB-03-01 Cream, 1% in Subjects With Facial Acne Vulgaris (25)

A Phase 3 study testing CB-03-01 cream, 1% in people with Acne Vulgaris, run by Cassiopea SpA at 54 sites in 3 countries.

Completed

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

Official record

Search all trials

Trial summary

The primary objective of this study is to determine the safety and efficacy of CB-03-01 cream, 1%, versus the vehicle cream applied twice daily for 12 weeks in subjects with facial acne vulgaris. Read more about this study

Who is it for?: Ages 9 years and older
Conditions the study is for: Acne Vulgaris
What is being tested?: CB-03-01 cream, 1%
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 708 participants
Where: 54 sitesin 3 countries
Study dates: 21 Jan 2016to 11 Apr 2018
Phase: Phase 3
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 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Subject is male or non-pregnant female, 9 years of age or older. Females must be post-menopausal, surgically sterile, or using highly effective birth control methods. Women of child-bearing potential must have a negative urine pregnancy test (UPT) at the Screening/Baseline Visit.
Subject has provided written and verbal informed consent/assent. A subject under 18 years of age must provide written informed assent and be accompanied by the parent or legal guardian at the time of assent/consent signing.
Subject has an Investigator's Global Assessment (IGA) score of 3 (moderate) or 4 (severe) [0 (clear) to 4 (severe) scale].
Subject has facial acne vulgaris with at least 30 to a maximum of 75 inflammatory lesions (papules, pustules, and nodules) and 30 to a maximum of 100 non-inflammatory lesions (open and closed comedones).
Subject and parent/guardian (if applicable) are willing to comply with study instructions and return to the clinic for required visits.
Subject has used the same type and brand of make-up, other facial products (exclusive of RX/OTC acne cleansers) and hair products (e.g., shampoo, gel, hair spray, mousse, etc.) for at least one (1) month prior to the Baseline Visit and agrees to continue his/her other general skin and hair care products and regimen for the entire study.

Who cannot join

Subject is pregnant, lactating, or is planning to become pregnant during the study.
Subject has any skin pathology or condition that could interfere with the evaluation of the test products or requires the use of interfering topical or systemic therapy.
Subject has greater than two (2) facial nodules.
Subject has nodulocystic acne.
Subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
Subject is currently enrolled in an investigational drug or device study.

Show all 14Show fewer

Subject has received an investigational drug or has been treated with an investigational device within 30 days prior to the initiation of treatment (Baseline).
Subject has facial hair that could interfere with the study assessments in the opinion of the investigator.
Subject and parent/guardian (if applicable) are unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function.
Subject may be unreliable for the study including subjects who engage in excessive alcohol intake or drug abuse, or subjects who are unable to return for scheduled follow-up visits.
Subject has known hypersensitivity or previous allergic reaction to any of the active or inactive components of the test articles.
Subject has the need or plans to be exposed to artificial tanning devices or excessive sunlight during the trial.
Subject has used any of the prohibited topical anti-acne treatments or procedures prior to the study unless appropriate washout period is documented.
Subject has used used any of the prohibited systemic anti-acne medications prior to the study unless appropriate washout period is documented.

Trial locations and contacts

54 sites in 3 countries.

Country

City, postcode or hospital

54 sites in 3 countries

United States44 sites

Westlake Dermatology Clinical Research Center
Austin, Texas, 78746
Bellaire Dermatology Associates
Bellaire, Texas, 77401
Site 0190
Boca Raton, Florida, 33434
Study Protocol, Inc.
Boynton Beach, Florida, 33437
Site 0152
Carmel, Indiana, 46032
J&S Studies, Inc.
College Station, Texas, 77845
Horizons Clinical Research Center, LLC
Denver, Colorado, 80220
Henry Ford Health System
Detroit, Michigan, 48202
Center For Dermatology Clinical Research, Inc.
Fremont, California, 94538
Greenville Dermatology, LLC
Greenville, South Carolina, 29607
The Pennsylvania State University and the Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Gary M. Petrus, MD PA
Little Rock, Arkansas, 72205
Vitiligo & Pigmentation Institute of Southern California
Los Angeles, California, 90036
Site 0196
Miami, Florida, 33125
Site 0197
Miami, Florida, 33126
Site 0198
Miami, Florida, 33135
Site 0199
Miami, Florida, 33145
Site 0191
Miami, Florida, 33172
Site 0192
Miami, Florida, 33172
Site 0195
Miami, Florida, 33176
The Center for Dermatology, Cosmetic & Laser Surgery
Mount Kisco, New York, 10549
International Clinical Research - Tennessee LLC
Murfreesboro, Tennessee, 37130
Tennessee Clinical Research Center
Nashville, Tennessee, 37215
MedaPhase, Inc.
Newnan, Georgia, 30263
Clinical Research Associates of Tidewater, Inc.
Norfolk, Virginia, 23507
Tory Sullivan, M.D., P.A.
North Miami Beach, Florida, 33162
Austin Institute for Clinical Research, Inc.
Pflugerville, Texas, 78660
The Indiana Clinical Trials Center
Plainfield, Indiana, 46168
Oregon Dermatology and Research Center
Portland, Oregon, 97210
Wake Research Associates
Raleigh, North Carolina, 27612
MediSearch Clinical Trials
Saint Joseph, Missouri, 64506
San Diego Sports Medicine and Family Health Center
San Diego, California, 92120
Rady Childrens Hospital, Pediatric and Adolescent Dermatology
San Diego, California, 92123
Southern California Dermatology
Santa Ana, California, 92701
Clinical Science Institute
Santa Monica, California, 90404
Dermatology Associates
Seattle, Washington, 98101
Premier Clinical Research
Spokane, Washington, 99202
Meridien Research
St. Petersburg, Florida, 33709
DermResearch Center of New York, Inc.
Stony Brook, New York, 11790
MOORE Clinical Research, Inc.
Tampa, Florida, 33609
Memorial Research Medical Clinic dba / Orange County Research Center
Tustin, California, 92780
Omega Medical Research
Warwick, Rhode Island, 02886
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157

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Georgia3 sites

Site 9911
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Site 9913
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Site 9912
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About this study

Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of Cortexolone 17α-Propionate (CB-03-01) Cream, 1% Applied Twice Daily for 12 Weeks in Subjects With Facial Acne Vulgaris

The primary objective of this study is to determine the safety and efficacy of CB-03-01 cream, 1%, versus the vehicle cream applied twice daily for 12 weeks in subjects with facial acne vulgaris.

Conditions: Acne Vulgaris
Being tested: CB-03-01 cream, 1%, Vehicle cream
Keywords: acne, clascoterone, 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.

CB-03-01 cream, 1%Drug
Also called cortexolone 17α-propionate, clascoterone (USAN, INN)
CB-03-01 (cortexolone 17α-propionate) is a steroidal antiandrogen that is being developed as a 1% cream for the topical treatment of acne vulgaris.
Vehicle creamDrug
Vehicle cream manufactured to mimic look and feel of CB-03-01 but without the active ingredient cortexolone 17α-propionate.

Study groups in NCT02608450
Study group	Role	What they receive
CB-03-01 cream	Experimental	CB-03-01 cream, 1% applied twice daily for 12 weeks Receives: Drug: CB-03-01 cream, 1%
Vehicle cream	Placebo comparator	Vehicle cream applied twice daily for 12 weeks Receives: Drug: Vehicle cream

What is being measured

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

Percentage of Participants Achieving Success in Investigator's Global Assessment (IGA)
Percentage of subjects in each treatment group achieving "success" at Week 12, with "success" defined as an IGA score of "clear (score=0)" or "almost clear (score=1)" and at least a two-point reduction in IGA compared to Baseline.
Measured: Week 12
Change From Baseline in Non-inflammatory Lesion Counts
Absolute change from Baseline in non-inflammatory lesion counts in each treatment group at Week 12.
Measured: Baseline and Week 12
Change From Baseline in Inflammatory Lesion Counts
Absolute change from Baseline in inflammatory lesion counts in each treatment group at Week 12.
Measured: Baseline and Week 12

Secondary outcomes (4)

Change From Baseline in Total Lesion Counts
Absolute change from Baseline in total lesions counts in each treatment group at Week 12.
Measured: Baseline and Week 12
Percent Change From Baseline in Total Lesion Counts
Percent change from Baseline in total lesions counts in each treatment group at Week 12.
Measured: Baseline and Week 12
Percent Change From Baseline in Non-inflammatory Lesion (NIL) Counts
Percent change from Baseline in non-inflammatory lesions count in each treatment group at Week 12.
Measured: Baseline and Week 12
Percent Change From Baseline in Inflammatory Lesion (IL) Counts
Percent change from Baseline in inflammatory lesions count in each treatment group at Week 12.
Measured: Baseline and Week 12

Timeline

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

21 Jan 201611 Apr 2018

First posted18 Nov 2015 (estimated)
Study start21 Jan 2016
Primary completion11 Apr 2018
Study completion11 Apr 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.
Publications (3)Papers the sponsor has linked to this study.
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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 708 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02608450
Sponsor's protocol ID: CB-03-01/25
Status last verified: Oct 2020
First submitted: 17 Nov 2015
Last updated: 20 Nov 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Hebert A, Eichenfield L, Thiboutot D, Stein Gold L, Vassileva S, Mihaylova Y, Cartwright M, Moro L, Fragasso E, Han J, Squittieri N, Mazzetti A. Efficacy and Safety of 1% Clascoterone Cream in Patients Aged > 12 Years With Acne Vulgaris. J Drugs Dermatol. 2023 Feb 1;22(2):174-181. doi: 10.36849/JDD.7000.
PubMed 36745367
Piszczatoski CR, Powell J. Topical Clascoterone: The First Novel Agent for Acne Vulgaris in 40 Years. Clin Ther. 2021 Oct;43(10):1638-1644. doi: 10.1016/j.clinthera.2021.08.007. Epub 2021 Oct 2.
PubMed 34607697
Hebert A, Thiboutot D, Stein Gold L, Cartwright M, Gerloni M, Fragasso E, Mazzetti A. Efficacy and Safety of Topical Clascoterone Cream, 1%, for Treatment in Patients With Facial Acne: Two Phase 3 Randomized Clinical Trials. JAMA Dermatol. 2020 Jun 1;156(6):621-630. doi: 10.1001/jamadermatol.2020.0465.
PubMed 32320027

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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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: A Phase 3, Multicenter, Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of Cortexolone 17α-Propionate (CB-03-01) Cream, 1% Applied Twice Daily for 12 Weeks in Subjects With Facial Acne Vulgaris
ClinicalTrials.gov ID: NCT02608450
Acronym / sponsor ID: CB-03-01/25
Conditions: Acne Vulgaris
Keywords: acne, clascoterone, anti-androgen
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 708 participants (actual)
Lead sponsor: Cassiopea SpAIndustry (pharma, biotech, devices)
Study start: 21 Jan 2016 (actual)
Primary completion: 11 Apr 2018 (actual)
Study completion: 11 Apr 2018 (actual)
First posted: 18 Nov 2015 (estimated)
Results: Posted 20 Nov 2020

Clinical summary

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

The primary objective of this study is to determine the safety and efficacy of CB-03-01 cream, 1%, versus the vehicle cream applied twice daily for 12 weeks in subjects with facial acne vulgaris.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
CB-03-01 cream	Experimental	Drug: CB-03-01 cream, 1%CB-03-01 cream, 1% applied twice daily for 12 weeks
Vehicle cream	Placebo comparator	Drug: Vehicle creamVehicle cream applied twice daily for 12 weeks

Who may qualify

Ages: 9 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (6 listed)

Subject is male or non-pregnant female, 9 years of age or older. Females must be post-menopausal, surgically sterile, or using highly effective birth control methods. Women of child-bearing potential must have a negative urine pregnancy test (UPT) at the Screening/Baseline Visit.
Subject has provided written and verbal informed consent/assent. A subject under 18 years of age must provide written informed assent and be accompanied by the parent or legal guardian at the time of assent/consent signing.
Subject has an Investigator's Global Assessment (IGA) score of 3 (moderate) or 4 (severe) [0 (clear) to 4 (severe) scale].
Subject has facial acne vulgaris with at least 30 to a maximum of 75 inflammatory lesions (papules, pustules, and nodules) and 30 to a maximum of 100 non-inflammatory lesions (open and closed comedones).
Subject and parent/guardian (if applicable) are willing to comply with study instructions and return to the clinic for required visits.

Key exclusion criteria (14 listed)

Subject is pregnant, lactating, or is planning to become pregnant during the study.
Subject has any skin pathology or condition that could interfere with the evaluation of the test products or requires the use of interfering topical or systemic therapy.
Subject has greater than two (2) facial nodules.
Subject has nodulocystic acne.
Subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research 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
CB-03-01 cream, 1%Also: cortexolone 17α-propionate, clascoterone (USAN, INN)CB-03-01 (cortexolone 17α-propionate) is a steroidal antiandrogen that is being developed as a 1% cream for the topical treatment of acne vulgaris.	Drug	CB-03-01 cream
Vehicle creamVehicle cream manufactured to mimic look and feel of CB-03-01 but without the active ingredient cortexolone 17α-propionate.	Drug	Vehicle cream

Primary outcome

Percentage of Participants Achieving Success in Investigator's Global Assessment (IGA)
Time frame: Week 12
Percentage of subjects in each treatment group achieving "success" at Week 12, with "success" defined as an IGA score of "clear (score=0)" or "almost clear (score=1)" and at least a two-point reduction in IGA compared to Baseline.
Change From Baseline in Non-inflammatory Lesion Counts
Time frame: Baseline and Week 12
Absolute change from Baseline in non-inflammatory lesion counts in each treatment group at Week 12.
Change From Baseline in Inflammatory Lesion Counts
Time frame: Baseline and Week 12
Absolute change from Baseline in inflammatory lesion counts in each treatment group at Week 12.

4 secondary outcomes

Change From Baseline in Total Lesion Counts
Time frame: Baseline and Week 12
Percent Change From Baseline in Total Lesion Counts
Time frame: Baseline and Week 12
Percent Change From Baseline in Non-inflammatory Lesion (NIL) Counts
Time frame: Baseline and Week 12
Percent Change From Baseline in Inflammatory Lesion (IL) Counts
Time frame: Baseline and Week 12

Results and safety

Results posted to the registry on 20 Nov 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	353	287
Vehicle Cream	355	290

Primary outcome: Percentage of Participants Achieving Success in Investigator's Global Assessment (IGA)

Time frame: Week 12. Number. Unit: Percentage of participants

Measure	CB-03-01 Cream n = 353	Vehicle Cream n = 355
Value	18.4	9.0

Population analysed: Intent-to-treat (ITT) population included all randomized subjects.

Primary outcome: Change From Baseline in Non-inflammatory Lesion Counts

Time frame: Baseline and Week 12. Mean (95% Confidence Interval). Unit: Non-inflammatory Lesions

Measure	CB-03-01 Cream n = 353	Vehicle Cream n = 355
Value	-19.4 (-22.6 to -16.7)	-13.0 (-15.7 to -10.3)

Population analysed: ITT population.

Primary outcome: Change From Baseline in Inflammatory Lesion Counts

Time frame: Baseline and Week 12. Mean (95% Confidence Interval). Unit: Inflammatory Lesions

Measure	CB-03-01 Cream n = 353	Vehicle Cream n = 355
Value	-19.3 (-21.1 to -17.5)	-15.5 (-17.3 to -13.6)

Population analysed: ITT population.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events (AEs) and serious adverse events (SAEs) were collected from screening visit, Baseline (Day 1) and up to Week 12/early termination.. Other adverse events reported at 0.6% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CB-03-01 Cream	0 of 353 (0%)	9 of 353 (2.5%)	0 of 353
Vehicle Cream	1 of 355 (0.3%)	18 of 355 (5.1%)	0 of 355

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.
Derived from this study: PubMed 36745367Hebert A, Eichenfield L, Thiboutot D, Stein Gold L, Vassileva S, Mihaylova Y, Cartwright M, Moro L, Fragasso E, Han J, Squittieri N, Mazzetti A. Efficacy and Safety of 1% Clascoterone Cream in Patients Aged > 12 Years With Acne Vulgaris. J Drugs Dermatol. 2023 Feb 1;22(2):174-181. doi: 10.36849/JDD.7000.
Derived from this study: PubMed 34607697Piszczatoski CR, Powell J. Topical Clascoterone: The First Novel Agent for Acne Vulgaris in 40 Years. Clin Ther. 2021 Oct;43(10):1638-1644. doi: 10.1016/j.clinthera.2021.08.007. Epub 2021 Oct 2.
Derived from this study: PubMed 32320027Hebert A, Thiboutot D, Stein Gold L, Cartwright M, Gerloni M, Fragasso E, Mazzetti A. Efficacy and Safety of Topical Clascoterone Cream, 1%, for Treatment in Patients With Facial Acne: Two Phase 3 Randomized Clinical Trials. JAMA Dermatol. 2020 Jun 1;156(6):621-630. doi: 10.1001/jamadermatol.2020.0465.

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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 Cassiopea study director

Cassiopea S.p.A.

54 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CB-03-01 cream, 1% in people with Acne Vulgaris, run by Cassiopea SpA at 54 sites in 3 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 6 inclusion and 14 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 54 sites in United States, Ukraine, Georgia. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 20 Nov 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?

Percentage of Participants Achieving Success in Investigator's Global Assessment (IGA) (time frame: Week 12). The study lists 3 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 NCT02608450, which also lists 3 linked publications.

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.