Acne Vulgaris
Conditions
Keywords
acne, anti-androgen, clascoterone, cassiopea
Brief 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.
Interventions
DRUGCB-03-01
Topical cream, applied once a day
DRUGVehicle
Topical cream, applied once or twice a day
Sponsors
Intrepid Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Investigator's Global Assessment (IGA) Success - Week 12 | 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 | Baseline and Week 12 | Absolute change from Baseline in inflammatory and non-inflammatory lesion counts in each treatment group at Week 12. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inflammatory and Non-Inflammatory Lesion Counts - Week 8 | Baseline and Week 8 | Absolute change from Baseline in inflammatory and non-inflammatory lesion counts in each treatment group at Week 8. |
| Percent Change in Lesion Counts - Weeks 8 and 12 | Week 8 and Week 12 | Percent change from Baseline in lesion counts (inflammatory and noninflammatory) in each treatment group at Weeks 8 and 12. |
| IGA Success - Week 8 | Baseline and 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). |
| IGA Clear or Almost Clear - Weeks 4, 8 and 12 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Low-dose Active, BID low dose of CB-03-01, 0.1% applied twice a day
CB-03-01: Topical cream, applied twice a day | 72 |
| Medium-dose Active, BID medium dose of CB-03-01, 0.5% applied twice a day
CB-03-01: Topical cream, applied twice a day | 76 |
| High-dose Active, QD high dose of CB-03-01, 1% applied once a day
CB-03-01: Topical cream, applied once a day | 70 |
| High-dose Active, BID high dose of CB-03-01, 1% applied twice a day
CB-03-01: Topical cream, applied twice a day | 70 |
| Vehicle, QD or BID vehicle cream, applied once or twice a day
Vehicle: Topical cream, applied once or twice a day | 75 |
| Total | 363 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Lack of Efficacy | 2 | 2 | 0 | 0 | 2 |
| Overall Study | Lost to Follow-up | 8 | 5 | 7 | 5 | 5 |
| Overall Study | Noncompliance with Study Drug | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 4 | 4 | 2 | 6 | 5 |
Baseline characteristics
| Characteristic | Low-dose Active, BID | Total | Vehicle, QD or BID | High-dose Active, BID | High-dose Active, QD | Medium-dose Active, BID |
|---|---|---|---|---|---|---|
| Age, Continuous | 19.8 years STANDARD_DEVIATION 5.77 | 19.7 years STANDARD_DEVIATION 5.99 | 19.2 years STANDARD_DEVIATION 5.25 | 21.0 years STANDARD_DEVIATION 6.22 | 18.3 years STANDARD_DEVIATION 6.14 | 20.4 years STANDARD_DEVIATION 6.31 |
| Baseline IGA 0 - Clear | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Baseline IGA 1 - Almost clear | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Baseline IGA 2 - Mild | 10 Participants | 60 Participants | 11 Participants | 18 Participants | 15 Participants | 6 Participants |
| Baseline IGA 3 - Moderate | 56 Participants | 247 Participants | 53 Participants | 32 Participants | 44 Participants | 62 Participants |
| Baseline IGA 4 - Severe | 6 Participants | 56 Participants | 11 Participants | 20 Participants | 11 Participants | 8 Participants |
| Baseline lesions counts Inflammatory lesions | 29.9 lesions | 30.0 lesions | 30.5 lesions | 28.6 lesions | 31.9 lesions | 29.0 lesions |
| Baseline lesions counts Non-inflammatory lesions | 43.5 lesions | 45.2 lesions | 43.9 lesions | 47.2 lesions | 46.7 lesions | 44.5 lesions |
| Ethnicity (NIH/OMB) Hispanic or Latino | 22 Participants | 76 Participants | 13 Participants | 15 Participants | 6 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 50 Participants | 287 Participants | 62 Participants | 55 Participants | 64 Participants | 56 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 3 Participants | 0 Participants | 2 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 16 Participants | 4 Participants | 4 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants | 74 Participants | 12 Participants | 20 Participants | 16 Participants | 14 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 9 Participants | 4 Participants | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 58 Participants | 257 Participants | 53 Participants | 42 Participants | 50 Participants | 54 Participants |
| Sex: Female, Male Female | 36 Participants | 196 Participants | 43 Participants | 37 Participants | 38 Participants | 42 Participants |
| Sex: Female, Male Male | 36 Participants | 167 Participants | 32 Participants | 33 Participants | 32 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 72 | 0 / 76 | 0 / 70 | 0 / 70 | 0 / 75 |
| other Total, other adverse events | 12 / 72 | 18 / 76 | 9 / 70 | 5 / 70 | 5 / 75 |
| serious Total, serious adverse events | 0 / 72 | 0 / 76 | 0 / 70 | 0 / 70 | 0 / 75 |
Outcome results
Primary
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.
Time frame: Baseline and Week 12
Population: Per protocol population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Low-dose Active, BID | Inflammatory and Non-Inflammatory Lesion Counts - Week 12 | Non-inflammatory lesions | -8.7 lesions | Standard Deviation 18.16 |
| Low-dose Active, BID | Inflammatory and Non-Inflammatory Lesion Counts - Week 12 | Inflammatory lesions | -8.3 lesions | Standard Deviation 14.63 |
| Medium-dose Active, BID | Inflammatory and Non-Inflammatory Lesion Counts - Week 12 | Non-inflammatory lesions | -6.1 lesions | Standard Deviation 29.22 |
| Medium-dose Active, BID | Inflammatory and Non-Inflammatory Lesion Counts - Week 12 | Inflammatory lesions | -5.8 lesions | Standard Deviation 11.99 |
| High-dose Active, QD | Inflammatory and Non-Inflammatory Lesion Counts - Week 12 | Non-inflammatory lesions | -8.4 lesions | Standard Deviation 21.55 |
| High-dose Active, QD | Inflammatory and Non-Inflammatory Lesion Counts - Week 12 | Inflammatory lesions | -10.1 lesions | Standard Deviation 12.53 |
| High-dose Active, BID | Inflammatory and Non-Inflammatory Lesion Counts - Week 12 | Inflammatory lesions | -12.3 lesions | Standard Deviation 14.43 |
| High-dose Active, BID | Inflammatory and Non-Inflammatory Lesion Counts - Week 12 | Non-inflammatory lesions | -15.5 lesions | Standard Deviation 20.48 |
| Vehicle, QD or BID | Inflammatory and Non-Inflammatory Lesion Counts - Week 12 | Inflammatory lesions | -9.1 lesions | Standard Deviation 13.67 |
| Vehicle, QD or BID | Inflammatory and Non-Inflammatory Lesion Counts - Week 12 | Non-inflammatory lesions | -6.7 lesions | Standard Deviation 19.65 |
Primary
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).
Time frame: Baseline and Week 12
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Low-dose Active, BID | Investigator's Global Assessment (IGA) Success - Week 12 | 5 Participants |
| Medium-dose Active, BID | Investigator's Global Assessment (IGA) Success - Week 12 | 3 Participants |
| High-dose Active, QD | Investigator's Global Assessment (IGA) Success - Week 12 | 2 Participants |
| High-dose Active, BID | Investigator's Global Assessment (IGA) Success - Week 12 | 6 Participants |
| Vehicle, QD or BID | Investigator's Global Assessment (IGA) Success - Week 12 | 2 Participants |
Secondary
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.
Time frame: Weeks 4, 8, and 12
Population: Per protocol population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Low-dose Active, BID | IGA Clear or Almost Clear - Weeks 4, 8 and 12 | Week 12 | 6 Participants |
| Low-dose Active, BID | IGA Clear or Almost Clear - Weeks 4, 8 and 12 | Week 4 | 3 Participants |
| Low-dose Active, BID | IGA Clear or Almost Clear - Weeks 4, 8 and 12 | Week 8 | 3 Participants |
| Medium-dose Active, BID | IGA Clear or Almost Clear - Weeks 4, 8 and 12 | Week 4 | 1 Participants |
| Medium-dose Active, BID | IGA Clear or Almost Clear - Weeks 4, 8 and 12 | Week 8 | 4 Participants |
| Medium-dose Active, BID | IGA Clear or Almost Clear - Weeks 4, 8 and 12 | Week 12 | 4 Participants |
| High-dose Active, QD | IGA Clear or Almost Clear - Weeks 4, 8 and 12 | Week 12 | 3 Participants |
| High-dose Active, QD | IGA Clear or Almost Clear - Weeks 4, 8 and 12 | Week 4 | 5 Participants |
| High-dose Active, QD | IGA Clear or Almost Clear - Weeks 4, 8 and 12 | Week 8 | 2 Participants |
| High-dose Active, BID | IGA Clear or Almost Clear - Weeks 4, 8 and 12 | Week 4 | 7 Participants |
| High-dose Active, BID | IGA Clear or Almost Clear - Weeks 4, 8 and 12 | Week 8 | 6 Participants |
| High-dose Active, BID | IGA Clear or Almost Clear - Weeks 4, 8 and 12 | Week 12 | 9 Participants |
| Vehicle, QD or BID | IGA Clear or Almost Clear - Weeks 4, 8 and 12 | Week 12 | 4 Participants |
| Vehicle, QD or BID | IGA Clear or Almost Clear - Weeks 4, 8 and 12 | Week 4 | 2 Participants |
| Vehicle, QD or BID | IGA Clear or Almost Clear - Weeks 4, 8 and 12 | Week 8 | 4 Participants |
Secondary
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).
Time frame: Baseline and Week 8
Population: Per protocol population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Low-dose Active, BID | IGA Success - Week 8 | 1 Participants |
| Medium-dose Active, BID | IGA Success - Week 8 | 3 Participants |
| High-dose Active, QD | IGA Success - Week 8 | 1 Participants |
| High-dose Active, BID | IGA Success - Week 8 | 4 Participants |
| Vehicle, QD or BID | IGA Success - Week 8 | 2 Participants |
Secondary
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.
Time frame: Baseline and Week 8
Population: Per protocol population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Low-dose Active, BID | Inflammatory and Non-Inflammatory Lesion Counts - Week 8 | Inflammatory lesions | -11.9 lesions | Standard Deviation 8.84 |
| Low-dose Active, BID | Inflammatory and Non-Inflammatory Lesion Counts - Week 8 | Non-inflammatory lesions | -7.0 lesions | Standard Deviation 13.76 |
| Medium-dose Active, BID | Inflammatory and Non-Inflammatory Lesion Counts - Week 8 | Inflammatory lesions | -7.2 lesions | Standard Deviation 12.03 |
| Medium-dose Active, BID | Inflammatory and Non-Inflammatory Lesion Counts - Week 8 | Non-inflammatory lesions | -6.7 lesions | Standard Deviation 16.33 |
| High-dose Active, QD | Inflammatory and Non-Inflammatory Lesion Counts - Week 8 | Inflammatory lesions | -7.2 lesions | Standard Deviation 17.21 |
| High-dose Active, QD | Inflammatory and Non-Inflammatory Lesion Counts - Week 8 | Non-inflammatory lesions | -3.2 lesions | Standard Deviation 37.01 |
| High-dose Active, BID | Inflammatory and Non-Inflammatory Lesion Counts - Week 8 | Non-inflammatory lesions | -13.6 lesions | Standard Deviation 17.99 |
| High-dose Active, BID | Inflammatory and Non-Inflammatory Lesion Counts - Week 8 | Inflammatory lesions | -11.5 lesions | Standard Deviation 11.19 |
| Vehicle, QD or BID | Inflammatory and Non-Inflammatory Lesion Counts - Week 8 | Inflammatory lesions | -11.3 lesions | Standard Deviation 12.71 |
| Vehicle, QD or BID | Inflammatory and Non-Inflammatory Lesion Counts - Week 8 | Non-inflammatory lesions | -8.3 lesions | Standard Deviation 17.12 |
Secondary
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.
Time frame: Week 8 and Week 12
Population: Per protocol population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Low-dose Active, BID | Percent Change in Lesion Counts - Weeks 8 and 12 | Inflammatory lesions (Week 12) | -26.8 percentage of change | Standard Deviation 50.78 |
| Low-dose Active, BID | Percent Change in Lesion Counts - Weeks 8 and 12 | Non-inflammatory lesions (Week 12) | -24.3 percentage of change | Standard Deviation 38.69 |
| Low-dose Active, BID | Percent Change in Lesion Counts - Weeks 8 and 12 | Inflammatory lesions (Week 8) | -40.6 percentage of change | Standard Deviation 28.2 |
| Low-dose Active, BID | Percent Change in Lesion Counts - Weeks 8 and 12 | Non-inflammatory lesions (Week 8) | -18.3 percentage of change | Standard Deviation 34.5 |
| Medium-dose Active, BID | Percent Change in Lesion Counts - Weeks 8 and 12 | Non-inflammatory lesions (Week 12) | -16.9 percentage of change | Standard Deviation 55.66 |
| Medium-dose Active, BID | Percent Change in Lesion Counts - Weeks 8 and 12 | Non-inflammatory lesions (Week 8) | -19.5 percentage of change | Standard Deviation 36.49 |
| Medium-dose Active, BID | Percent Change in Lesion Counts - Weeks 8 and 12 | Inflammatory lesions (Week 8) | -26.6 percentage of change | Standard Deviation 37.35 |
| Medium-dose Active, BID | Percent Change in Lesion Counts - Weeks 8 and 12 | Inflammatory lesions (Week 12) | -21.3 percentage of change | Standard Deviation 45.33 |
| High-dose Active, QD | Percent Change in Lesion Counts - Weeks 8 and 12 | Inflammatory lesions (Week 12) | -32.5 percentage of change | Standard Deviation 35.51 |
| High-dose Active, QD | Percent Change in Lesion Counts - Weeks 8 and 12 | Non-inflammatory lesions (Week 12) | -19.5 percentage of change | Standard Deviation 40.75 |
| High-dose Active, QD | Percent Change in Lesion Counts - Weeks 8 and 12 | Inflammatory lesions (Week 8) | -27.5 percentage of change | Standard Deviation 41.44 |
| High-dose Active, QD | Percent Change in Lesion Counts - Weeks 8 and 12 | Non-inflammatory lesions (Week 8) | -10.5 percentage of change | Standard Deviation 57.13 |
| High-dose Active, BID | Percent Change in Lesion Counts - Weeks 8 and 12 | Inflammatory lesions (Week 8) | -41.1 percentage of change | Standard Deviation 36.54 |
| High-dose Active, BID | Percent Change in Lesion Counts - Weeks 8 and 12 | Non-inflammatory lesions (Week 8) | -33.5 percentage of change | Standard Deviation 39.26 |
| High-dose Active, BID | Percent Change in Lesion Counts - Weeks 8 and 12 | Non-inflammatory lesions (Week 12) | -34.1 percentage of change | Standard Deviation 46.95 |
| High-dose Active, BID | Percent Change in Lesion Counts - Weeks 8 and 12 | Inflammatory lesions (Week 12) | -41.8 percentage of change | Standard Deviation 52.25 |
| Vehicle, QD or BID | Percent Change in Lesion Counts - Weeks 8 and 12 | Inflammatory lesions (Week 12) | -28.4 percentage of change | Standard Deviation 41.88 |
| Vehicle, QD or BID | Percent Change in Lesion Counts - Weeks 8 and 12 | Inflammatory lesions (Week 8) | -36.0 percentage of change | Standard Deviation 35.01 |
| Vehicle, QD or BID | Percent Change in Lesion Counts - Weeks 8 and 12 | Non-inflammatory lesions (Week 8) | -24.3 percentage of change | Standard Deviation 43.23 |
| Vehicle, QD or BID | Percent Change in Lesion Counts - Weeks 8 and 12 | Non-inflammatory lesions (Week 12) | -19.5 percentage of change | Standard Deviation 47.43 |