Acne Vulgaris
Conditions
Keywords
acne, cortexolone, anti-androgen
Brief summary
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.
Interventions
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.
Sponsors
Cassiopea SpA
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
9 Years to 11 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HPA Axis Response as Measured by CST | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate Trough Plasma Concentrations | 14 Days | 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. |
Countries
Poland, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CB-03-01 Cream, 1% Topical CB-03-01 (cortexolone 17α-propionate) cream containing 1% active drug applied to the face and trunk twice daily for 14 days
cortexolone 17α-propionate (USAN/INN: clascoterone): is a topical steroidal antiandrogen that is being developed for the potential treatment of acne vulgaris, an androgen-dependent skin disorder. | 27 |
| Total | 27 |
Baseline characteristics
| Characteristic | CB-03-01 Cream, 1% |
|---|---|
| Age, Continuous | 10.2 years STANDARD_DEVIATION 0.9 |
| Baseline HPA Axis Response Cortisol Level (Post-CST) | 24.87 mcg/dL STANDARD_DEVIATION 3.7 |
| Baseline HPA Axis Response Cortisol Level (Pre-CST) | 13.53 mcg/dL STANDARD_DEVIATION 4.53 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 25 Participants |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 27 |
| other Total, other adverse events | 5 / 27 |
| serious Total, serious adverse events | 0 / 27 |
Outcome results
Primary
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.
Time frame: Pre- and Post-CST on Day 14
Population: Evaluable population, defined as all subjects in the safety population who had evaluable cortisol assay data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CB-03-01 Cream, 1% | Change in HPA Axis Response as Measured by CST | Cortisol level (Pre-CST) | 12.50 mcg/dL | Standard Deviation 4.9 |
| CB-03-01 Cream, 1% | Change in HPA Axis Response as Measured by CST | Cortisol level (Post-CST) | 22.95 mcg/dL | Standard Deviation 3.2 |
Secondary
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.
Time frame: 14 Days
Population: The pharmacokinetic (PK) population included those subjects in the Safety population who had at least an 80% dose compliance based on number of applications, had at least one post-baseline PK blood draw within ±2 days of the scheduled visit at Days 7 and 14, and did not have any significant protocol deviations.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CB-03-01 Cream, 1% | Evaluate Trough Plasma Concentrations | Screening | 0.0 ng/mL | Standard Deviation 0 |
| CB-03-01 Cream, 1% | Evaluate Trough Plasma Concentrations | Baseline (Day 1) | 0.027 ng/mL | Standard Deviation 0.136 |
| CB-03-01 Cream, 1% | Evaluate Trough Plasma Concentrations | Day 7 | 0.577 ng/mL | Standard Deviation 1.01 |
| CB-03-01 Cream, 1% | Evaluate Trough Plasma Concentrations | Day 14 | 0.606 ng/mL | Standard Deviation 0.701 |