Acne Vulgaris
Conditions
Keywords
acne, clascoterone, anti-androgen
Brief 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.
Interventions
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.
DRUGVehicle cream
Vehicle cream manufactured to mimic look and feel of CB-03-01 but without the active ingredient cortexolone 17α-propionate.
Sponsors
Cassiopea SpA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
9 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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. 2. 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. 3. Subject has an Investigator's Global Assessment (IGA) score of 3 (moderate) or 4 (severe) \[0 (clear) to 4 (severe) scale\]. 4. 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). 5. Subject and parent/guardian (if applicable) are willing to comply with study instructions and return to the clinic for required visits. 6. 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.
Exclusion criteria
1. Subject is pregnant, lactating, or is planning to become pregnant during the study. 2. 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. 3. Subject has greater than two (2) facial nodules. 4. Subject has nodulocystic acne. 5. Subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study. 6. Subject is currently enrolled in an investigational drug or device study. 7. Subject has received an investigational drug or has been treated with an investigational device within 30 days prior to the initiation of treatment (Baseline). 8. Subject has facial hair that could interfere with the study assessments in the opinion of the investigator. 9. 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. 10. 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. 11. Subject has known hypersensitivity or previous allergic reaction to any of the active or inactive components of the test articles. 12. Subject has the need or plans to be exposed to artificial tanning devices or excessive sunlight during the trial. 13. Subject has used any of the prohibited topical anti-acne treatments or procedures prior to the study unless appropriate washout period is documented. 14. Subject has used used any of the prohibited systemic anti-acne medications prior to the study unless appropriate washout period is documented.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Inflammatory Lesion Counts | Baseline and Week 12 | Absolute change from Baseline in inflammatory lesion counts in each treatment group at Week 12. |
| Percentage of Participants Achieving Success in Investigator's Global Assessment (IGA) | 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 | Baseline and Week 12 | Absolute change from Baseline in non-inflammatory lesion counts in each treatment group at Week 12. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Non-inflammatory Lesion (NIL) Counts | Baseline and Week 12 | Percent change from Baseline in non-inflammatory lesions count in each treatment group at Week 12. |
| Percent Change From Baseline in Inflammatory Lesion (IL) Counts | Baseline and Week 12 | Percent change from Baseline in inflammatory lesions count in each treatment group at Week 12. |
| Change From Baseline in Total Lesion Counts | Baseline and Week 12 | Absolute change from Baseline in total lesions counts in each treatment group at Week 12. |
| Percent Change From Baseline in Total Lesion Counts | Baseline and Week 12 | Percent change from Baseline in total lesions counts in each treatment group at Week 12. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Local Site Reactions | Baseline, Weeks 4, 8, and 12 | Local Site Reactions (LSRs) including telangiectasia, skin atrophy, striae rubrae, erythema, edema, scaling/dryness, stinging/burning, and pruritus scored by frequency and severity at every visit (Baseline, Weeks 4, 8, and 12). |
Countries
Georgia, Ukraine, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CB-03-01 Cream CB-03-01 cream, 1% applied twice daily for 12 weeks
Cortexolone 17α-propionate (USAN/INN: clascoterone) is a steroidal antiandrogen that is being developed as a 1% cream for the topical treatment of acne vulgaris. | 353 |
| Vehicle Cream Vehicle cream applied twice daily for 12 weeks
Vehicle cream: Vehicle cream manufactured to mimic look and feel of CB-03-01 but without the active ingredient cortexolone 17α-propionate. | 355 |
| Total | 708 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 6 |
| Overall Study | Lack of Efficacy | 0 | 3 |
| Overall Study | Lost to Follow-up | 39 | 32 |
| Overall Study | Multiple reasons | 0 | 2 |
| Overall Study | Noncompliance with study drug | 0 | 2 |
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Pregnancy | 0 | 1 |
| Overall Study | Progressive disease | 1 | 0 |
| Overall Study | Withdrawal by parent | 2 | 3 |
| Overall Study | Withdrawal by Subject | 21 | 15 |
Baseline characteristics
| Characteristic | Vehicle Cream | Total | CB-03-01 Cream |
|---|---|---|---|
| Age, Continuous | 19.9 years STANDARD_DEVIATION 6.8 | 19.9 years STANDARD_DEVIATION 6.7 | 20.0 years STANDARD_DEVIATION 6.7 |
| Baseline Acne Lesion Counts Inflammatory lesions | 42.9 Lesions STANDARD_DEVIATION 12.3 | 42.7 Lesions STANDARD_DEVIATION 12.1 | 42.4 Lesions STANDARD_DEVIATION 11.8 |
| Baseline Acne Lesion Counts Non-inflammatory lesions | 60.7 Lesions STANDARD_DEVIATION 22.1 | 59.9 Lesions STANDARD_DEVIATION 22.1 | 59.1 Lesions STANDARD_DEVIATION 22.2 |
| Baseline Acne Lesion Counts Total Lesion Count | 103.6 Lesions STANDARD_DEVIATION 26.1 | 102.6 Lesions STANDARD_DEVIATION 25.6 | 101.5 Lesions STANDARD_DEVIATION 25.1 |
| Baseline IGA 0 - Clear | 0 Participants | 0 Participants | 0 Participants |
| Baseline IGA 1 - Almost Clear | 0 Participants | 0 Participants | 0 Participants |
| Baseline IGA 2- Mild | 0 Participants | 0 Participants | 0 Participants |
| Baseline IGA 3 - Moderate | 291 Participants | 583 Participants | 292 Participants |
| Baseline IGA 4 - Severe | 64 Participants | 125 Participants | 61 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 80 Participants | 174 Participants | 94 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 275 Participants | 534 Participants | 259 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 10 Participants | 19 Participants | 9 Participants |
| Race (NIH/OMB) Black or African American | 38 Participants | 69 Participants | 31 Participants |
| Race (NIH/OMB) More than one race | 7 Participants | 16 Participants | 9 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 6 Participants | 4 Participants |
| Race (NIH/OMB) White | 297 Participants | 595 Participants | 298 Participants |
| Sex: Female, Male Female | 215 Participants | 436 Participants | 221 Participants |
| Sex: Female, Male Male | 140 Participants | 272 Participants | 132 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 353 | 0 / 355 |
| other Total, other adverse events | 9 / 353 | 18 / 355 |
| serious Total, serious adverse events | 0 / 353 | 1 / 355 |
Outcome results
Primary
Change From Baseline in Inflammatory Lesion Counts
Absolute change from Baseline in inflammatory lesion counts in each treatment group at Week 12.
Time frame: Baseline and Week 12
Population: ITT population.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CB-03-01 Cream | Change From Baseline in Inflammatory Lesion Counts | -19.3 Inflammatory Lesions |
| Vehicle Cream | Change From Baseline in Inflammatory Lesion Counts | -15.5 Inflammatory Lesions |
Primary
Change From Baseline in Non-inflammatory Lesion Counts
Absolute change from Baseline in non-inflammatory lesion counts in each treatment group at Week 12.
Time frame: Baseline and Week 12
Population: ITT population.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CB-03-01 Cream | Change From Baseline in Non-inflammatory Lesion Counts | -19.4 Non-inflammatory Lesions |
| Vehicle Cream | Change From Baseline in Non-inflammatory Lesion Counts | -13.0 Non-inflammatory Lesions |
Primary
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.
Time frame: Week 12
Population: Intent-to-treat (ITT) population included all randomized subjects.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CB-03-01 Cream | Percentage of Participants Achieving Success in Investigator's Global Assessment (IGA) | 18.4 Percentage of participants |
| Vehicle Cream | Percentage of Participants Achieving Success in Investigator's Global Assessment (IGA) | 9.0 Percentage of participants |
Secondary
Change From Baseline in Total Lesion Counts
Absolute change from Baseline in total lesions counts in each treatment group at Week 12.
Time frame: Baseline and Week 12
Population: ITT population
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CB-03-01 Cream | Change From Baseline in Total Lesion Counts | -39.1 Total lesions |
| Vehicle Cream | Change From Baseline in Total Lesion Counts | -28.8 Total lesions |
Secondary
Percent Change From Baseline in Inflammatory Lesion (IL) Counts
Percent change from Baseline in inflammatory lesions count in each treatment group at Week 12.
Time frame: Baseline and Week 12
Population: ITT population.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CB-03-01 Cream | Percent Change From Baseline in Inflammatory Lesion (IL) Counts | -44.8 percent change |
| Vehicle Cream | Percent Change From Baseline in Inflammatory Lesion (IL) Counts | -36.5 percent change |
Secondary
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.
Time frame: Baseline and Week 12
Population: ITT population.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CB-03-01 Cream | Percent Change From Baseline in Non-inflammatory Lesion (NIL) Counts | -30.6 percent change |
| Vehicle Cream | Percent Change From Baseline in Non-inflammatory Lesion (NIL) Counts | -21.6 percent change |
Secondary
Percent Change From Baseline in Total Lesion Counts
Percent change from Baseline in total lesions counts in each treatment group at Week 12.
Time frame: Baseline and Week 12
Population: ITT population
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CB-03-01 Cream | Percent Change From Baseline in Total Lesion Counts | -37.0 percent change |
| Vehicle Cream | Percent Change From Baseline in Total Lesion Counts | -28.4 percent change |
Other Pre-specified
Local Site Reactions
Local Site Reactions (LSRs) including telangiectasia, skin atrophy, striae rubrae, erythema, edema, scaling/dryness, stinging/burning, and pruritus scored by frequency and severity at every visit (Baseline, Weeks 4, 8, and 12).
Time frame: Baseline, Weeks 4, 8, and 12