Acne VulgarisPhase 2NCT01631474

A Phase 2 Dose Escalating Study to Evaluate the Safety and Efficacy of CB-03-01 Cream in Subjects With Facial Acne Vulgaris

A Phase 2 study testing CB-03-01 in people with Acne Vulgaris, run by Intrepid Therapeutics, Inc. at 13 sites in United States.

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

CB-03-01 is being developed for the topical treatment of acne vulgaris, an androgen-dependent skin disorder. The purpose of this study is to compare the safety and efficacy of multiple concentrations of CB-03-01 to vehicle in the treatment of acne vulgaris. Read more about this study

Who is it for?: Ages 12 years and older
Conditions the study is for: Acne Vulgaris
What is being tested?: CB-03-01
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 363 participants
Where: 13 sitesUnited States
Study dates: Jun 2012to Feb 2014
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 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. Females must be post-menopausal, surgically sterile or using highly effective birth control methods.
Subject has provided written and verbal informed consent/assent.
Subject has facial acne vulgaris (including the nose).
Subject is 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 (including cleanser) and hair products (e.g., shampoo, gel, hair spray, mousse, etc.) for at least one month prior to the study start 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 is currently enrolled in an investigational drug or device study.
Subject has received an investigational drug or been treated with an investigational device within 30 days prior to the study start.
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 following topical anti-acne preparations or procedures on the face:
Topical anti-acne treatments including but not limited to over-the-counter acne cleaners or treatments, benzoyl peroxide, antibiotics, azelaic acid, sulfa based products, corticosteroids and salicylic acid within two weeks of the initiation of treatment.

Show all 13Show fewer

Retinoids, including tazarotene, adapalene, tretinoin, within four weeks of the initiation of treatment.
Light treatments, microdermabrasion or chemical peels within eight weeks of the initiation of treatment.
Subject has used the following systemic anti-acne medications:
Corticosteroids (including intramuscular and intralesional injections) within four weeks of the initiation of treatment. Inhaled, intranasal or ocular corticosteroids are allowed if use is stable (stable use is defined as dose and frequency unchanged for at least four weeks prior to the initiation of treatment).
Antibiotics within four weeks of the initiation of treatment with the exception of five days or less of antibiotic therapy during this period, but with no antibiotics use permitted within one week prior to the initiation of treatment.
Spironolactone within eight weeks of the initiation of treatment with the exception of five days or less of spironolactone therapy during this period, but with no spironolactone use permitted within one week prior to the initiation of treatment.
Retinoid therapy within six months of the initiation of treatment.

Trial locations and contacts

13 sites in 1 country.

City, postcode or hospital

13 sites in 1 country

United States13 sites

Altman Dermatology Associates
Arlington Heights, Illinois, 60005
J & S Studies
College Station, Texas, 77845
Penn State Milton S. Hershey Medical Center - Dept. of Dermatology
Hershey, Pennsylvania, 17033
UT Houston Health Science Center
Houston, Texas, 77030
Clinical Partners, LLC
Johnston, Rhode Island
Dermatology Research Associates
Los Angeles, California, 90045
Virginia Clinical Research
Norfolk, Virginia, 23507
Indiana Clinical Trials Center
Plainfield, Indiana, 46168
Therapeutics Clinical Research
San Diego, California, 92123
University Clinical Trials
San Diego, California, 92123
International Clinical Research - US, LLC
Sanford, Florida
Marina I. Peredo, M.D., PC
Smithtown, New York
Gwinnett Clinical Research Center, Inc.
Snellville, Georgia, 30078

Other trials in United States

About this study

Official title: A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Dose Escalating Study to Evaluate the Safety and Efficacy of Cortexolone 17a-Propionate (CB-03-01) Cream Applied Once or Twice-Daily for 12 Weeks in Subjects With Facial Acne Vulgaris

Conditions: Acne Vulgaris
Being tested: CB-03-01, Vehicle
Keywords: acne, anti-androgen, clascoterone, cassiopea
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-03-01Drug
Also called clascoterone
Topical cream, applied once a day
VehicleDrug
Topical cream, applied once or twice a day
CB-03-01Drug
Also called clascoterone
Topical cream, applied twice a day

Study groups in NCT01631474
Study group	Role	What they receive
Low-dose active, BID	Experimental	low dose of CB-03-01, 0.1% applied twice a day Receives: Drug: CB-03-01
Medium-dose active, BID	Experimental	medium dose of CB-03-01, 0.5% applied twice a day Receives: Drug: CB-03-01
High-dose active, QD	Experimental	high dose of CB-03-01, 1% applied once a day Receives: Drug: CB-03-01
High-dose active, BID	Experimental	high dose of CB-03-01, 1% applied twice a day Receives: Drug: CB-03-01
Vehicle, QD or BID	Placebo comparator	vehicle cream, applied once or twice a day Receives: Drug: Vehicle

What is being measured

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

Investigator's Global Assessment (IGA) "Success" - Week 12
Count and percentage of subjects achieving success in each treatment group at Week 12 using the dichotomized IGA with success defined as a score of "clear" or "almost clear" (IGA Score of 0 or 1) and a two or more grade improvement from Baseline using a five-point scale (0=clear to 4=severe).
Measured: Baseline and Week 12
Inflammatory and Non-Inflammatory Lesion Counts - Week 12
Absolute change from Baseline in inflammatory and non-inflammatory lesion counts in each treatment group at Week 12.
Measured: Baseline and Week 12

Secondary outcomes (4)

Inflammatory and Non-Inflammatory Lesion Counts - Week 8
Absolute change from Baseline in inflammatory and non-inflammatory lesion counts in each treatment group at Week 8.
Measured: Baseline and Week 8
Percent Change in Lesion Counts - Weeks 8 and 12
Percent change from Baseline in lesion counts (inflammatory and noninflammatory) in each treatment group at Weeks 8 and 12.
Measured: Week 8 and Week 12
IGA "Success" - Week 8
Count and percentage of subjects achieving success per the IGA in each treatment group at Week 8 ("success" as defined in the primary endpoints section).
Measured: Baseline and Week 8
IGA "Clear" or "Almost Clear" - Weeks 4, 8 and 12
Count and percentage of subjects who are "clear" or "almost clear" (IGA Grade 0 or 1) in each treatment group at Weeks 4, 8 and 12.
Measured: Weeks 4, 8, and 12

Timeline

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

Jun 2012Feb 2014

First posted29 Jun 2012 (estimated)
Study startJun 2012
Primary completionFeb 2014
Study completionFeb 2014

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: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 363 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01631474
Sponsor's protocol ID: 171-7151-201
Status last verified: Oct 2020
First submitted: 27 Jun 2012
Last updated: 16 Nov 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: 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

Not yet recruiting
Evaluating a Brightening Serum for Post-Inflammatory Hyperpigmentation
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Acne Vulgaris
Enrolling by invitationPhase 2/3
A Split-Face Comparative Study of Mono Threads Versus Combination With Plasma Gel for the Treatment of Post-Acne Scars
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RecruitingObservational study
Collection of Samples From Subjects With Various Skin Conditions and Healthy Volunteers
Acne, Atopic Dermatitis
RecruitingPhase 3
Study of New Antiandrogenic Progestogen + Low-dose Estrogen for Moderate Acne Vulgaris
Acne Vulgaris, Acne Vulgaris on the Face

All Acne Vulgaris trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Dose Escalating Study to Evaluate the Safety and Efficacy of Cortexolone 17a-Propionate (CB-03-01) Cream Applied Once or Twice-Daily for 12 Weeks in Subjects With Facial Acne Vulgaris
ClinicalTrials.gov ID: NCT01631474
Acronym / sponsor ID: 171-7151-201
Conditions: Acne Vulgaris
Keywords: acne, anti-androgen, clascoterone, cassiopea
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 363 participants (actual)
Lead sponsor: Intrepid Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: Jun 2012
Primary completion: Feb 2014 (actual)
Study completion: Feb 2014 (actual)
First posted: 29 Jun 2012 (estimated)
Results: Posted 16 Nov 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: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 5

Arm	Type	Receives
Low-dose active, BID	Experimental	Drug: CB-03-01low dose of CB-03-01, 0.1% applied twice a day
Medium-dose active, BID	Experimental	Drug: CB-03-01medium dose of CB-03-01, 0.5% applied twice a day
High-dose active, QD	Experimental	Drug: CB-03-01high dose of CB-03-01, 1% applied once a day
High-dose active, BID	Experimental	Drug: CB-03-01high dose of CB-03-01, 1% applied twice a day
Vehicle, QD or BID	Placebo comparator	Drug: Vehiclevehicle cream, applied once or twice a day

Who may qualify

Ages: 12 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (5 listed)

Subject is male or non-pregnant female. Females must be post-menopausal, surgically sterile or using highly effective birth control methods.
Subject has provided written and verbal informed consent/assent.
Subject has facial acne vulgaris (including the nose).
Subject is 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 (including cleanser) and hair products (e.g., shampoo, gel, hair spray, mousse, etc.) for at least one month prior to the study start and agrees to continue his/her other general skin and hair care products and regimen for the entire study.

Key exclusion criteria (13 listed)

Subject is pregnant, lactating, or is planning to become pregnant during the study.
Subject is currently enrolled in an investigational drug or device study.
Subject has received an investigational drug or been treated with an investigational device within 30 days prior to the study start.
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 following topical anti-acne preparations or procedures on the face:

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-03-01Also: clascoteroneTopical cream, applied once a day	Drug	High-dose active, QD
VehicleTopical cream, applied once or twice a day	Drug	Vehicle, QD or BID
CB-03-01Also: clascoteroneTopical cream, applied twice a day	Drug	High-dose active, BID, Low-dose active, BID, Medium-dose active, BID

Primary outcome

Investigator's Global Assessment (IGA) "Success" - Week 12
Time frame: Baseline and Week 12
Count and percentage of subjects achieving success in each treatment group at Week 12 using the dichotomized IGA with success defined as a score of "clear" or "almost clear" (IGA Score of 0 or 1) and a two or more grade improvement from Baseline using a five-point scale (0=clear to 4=severe).
Inflammatory and Non-Inflammatory Lesion Counts - Week 12
Time frame: Baseline and Week 12
Absolute change from Baseline in inflammatory and non-inflammatory lesion counts in each treatment group at Week 12.

4 secondary outcomes

Inflammatory and Non-Inflammatory Lesion Counts - Week 8
Time frame: Baseline and Week 8
Percent Change in Lesion Counts - Weeks 8 and 12
Time frame: Week 8 and Week 12
IGA "Success" - Week 8
Time frame: Baseline and Week 8
IGA "Clear" or "Almost Clear" - Weeks 4, 8 and 12
Time frame: Weeks 4, 8, and 12

Results and safety

Results posted to the registry on 16 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
Low-dose Active, BID	72	58
Medium-dose Active, BID	76	64
High-dose Active, QD	70	61
High-dose Active, BID	70	59
Vehicle, QD or BID	75	62

Primary outcome: Investigator's Global Assessment (IGA) "Success" - Week 12

Time frame: Baseline and Week 12. Count of participants. Unit: Participants

Measure	Low-dose Active, BID n = 57	Medium-dose Active, BID n = 64	High-dose Active, QD n = 52	High-dose Active, BID n = 55	Vehicle, QD or BID n = 59
Value	5	3	2	6	2

Population analysed: Per-Protocol Population, defined as a subset of the ITT population and included those subjects that met eligibility criteria, completed the end-of-study visit, and applied at least 80% of the expected treatment applications.

Primary outcome: Inflammatory and Non-Inflammatory Lesion Counts - Week 12

Time frame: Baseline and Week 12. Mean (Standard Deviation). Unit: lesions

Measure	Low-dose Active, BID n = 55	Medium-dose Active, BID n = 62	High-dose Active, QD n = 52	High-dose Active, BID n = 55	Vehicle, QD or BID n = 57
Inflammatory lesions	-8.3 (14.63)	-5.8 (11.99)	-10.1 (12.53)	-12.3 (14.43)	-9.1 (13.67)
Non-inflammatory lesions	-8.7 (18.16)	-6.1 (29.22)	-8.4 (21.55)	-15.5 (20.48)	-6.7 (19.65)

Population analysed: Per protocol population.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events (AEs) were collected from screening visit, Baseline (Day 1) and up to Week 12/early termination.. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Low-dose Active, BID	0 of 72 (0%)	12 of 72 (16.7%)	0 of 72
Medium-dose Active, BID	0 of 76 (0%)	18 of 76 (23.7%)	0 of 76
High-dose Active, QD	0 of 70 (0%)	9 of 70 (12.9%)	0 of 70
High-dose Active, BID	0 of 70 (0%)	5 of 70 (7.1%)	0 of 70
Vehicle, QD or BID	0 of 75 (0%)	5 of 75 (6.7%)	0 of 75

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Acne Vulgaris

Not yet recruiting
Evaluating a Brightening Serum for Post-Inflammatory Hyperpigmentation
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RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
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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.

13 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CB-03-01 in people with Acne Vulgaris, run by Intrepid Therapeutics, Inc. at 13 sites in United States.

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 13 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 16 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 13 sites in 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. 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 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 16 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?

Investigator's Global Assessment (IGA) "Success" - Week 12 (time frame: Baseline and Week 12). The study lists 2 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 NCT01631474.

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 16 Nov 2020; AzTrials last refreshed its copy on 1 Nov 2026.