Trial Outcomes & Findings for An Evaluation of the Adrenal Suppression Potential and PK of CB-03-01 Cream in Pediatric Patients With Acne Vulgaris (NCT NCT02720627)

NCT ID: NCT02720627

Last Updated: 2020-11-20

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

27 participants

Primary outcome timeframe

Pre- and Post-CST on Day 14

Results posted on

2020-11-20

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	27
Overall Study COMPLETED	27
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluable Population, defined as all subjects in the Safety population who had evaluable cortisol assay data.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CB-03-01 Cream, 1% n=27 Participants 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.
Age, Continuous	10.2 years STANDARD_DEVIATION 0.9 • n=27 Participants
Sex: Female, Male Female	22 Participants n=27 Participants
Sex: Female, Male Male	5 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=27 Participants
Race (NIH/OMB) Asian	1 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	1 Participants n=27 Participants
Race (NIH/OMB) White	25 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=27 Participants
Baseline HPA Axis Response Cortisol Level (Pre-CST)	13.53 mcg/dL STANDARD_DEVIATION 4.53 • n=23 Participants • Evaluable Population, defined as all subjects in the Safety population who had evaluable cortisol assay data.
Baseline HPA Axis Response Cortisol Level (Post-CST)	24.87 mcg/dL STANDARD_DEVIATION 3.70 • n=23 Participants • Evaluable Population, defined as all subjects in the Safety population who had evaluable cortisol assay data.

PRIMARY outcome

Timeframe: Pre- and Post-CST on Day 14

Population: Evaluable population, defined as all subjects in the safety population who had evaluable cortisol assay data.

Outcome measures

Outcome measures
Measure	CB-03-01 Cream, 1% n=23 Participants 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.
Change in HPA Axis Response as Measured by CST Cortisol level (Pre-CST)	12.50 mcg/dL Standard Deviation 4.90
Change in HPA Axis Response as Measured by CST Cortisol level (Post-CST)	22.95 mcg/dL Standard Deviation 3.20

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	CB-03-01 Cream, 1% n=25 Participants 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.
Evaluate Trough Plasma Concentrations Screening	0.0 ng/mL Standard Deviation 0.0
Evaluate Trough Plasma Concentrations Baseline (Day 1)	0.027 ng/mL Standard Deviation 0.136
Evaluate Trough Plasma Concentrations Day 7	0.577 ng/mL Standard Deviation 1.01
Evaluate Trough Plasma Concentrations Day 14	0.606 ng/mL Standard Deviation 0.701

Adverse Events

CB-03-01 Cream, 1%

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	CB-03-01 Cream, 1% n=27 participants at risk 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: clasocoterone): is a topical steroidal antiandrogen that is being developed for the potential treatment of acne vulgaris, an androgen-dependent skin disorder.
Blood and lymphatic system disorders Leukopenia	3.7% 1/27 • Number of events 1 • 14 Days or up to 42 days for those with laboratory evidence of adrenal suppression (i.e., post-stimulation serum cortisol level ≤18 μg/dL at Day 14). Any treatment emergent AEs ongoing at the end of the treatment period (Day 14) were followed until they resolve, the condition stabilizes, the events are otherwise explained, or the subject is lost to follow-up. In addition, all SAEs were followed until resolution as previously stated for study product-related AEs. Subjects with laboratory evidence of adrenal suppression at Day 14 were required to be re-tested 4 weeks later (Day 42); all four subjects returned to normal HPA function.
Investigations ACTH stimulation test abnormal	14.8% 4/27 • Number of events 4 • 14 Days or up to 42 days for those with laboratory evidence of adrenal suppression (i.e., post-stimulation serum cortisol level ≤18 μg/dL at Day 14). Any treatment emergent AEs ongoing at the end of the treatment period (Day 14) were followed until they resolve, the condition stabilizes, the events are otherwise explained, or the subject is lost to follow-up. In addition, all SAEs were followed until resolution as previously stated for study product-related AEs. Subjects with laboratory evidence of adrenal suppression at Day 14 were required to be re-tested 4 weeks later (Day 42); all four subjects returned to normal HPA function.

Additional Information

Cassiopea R&D

Cassiopea, SpA

Phone: +39 02 868 911 24

Email: r&[email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Sponsor has first right to publish pooled study data. In the event that such manuscript has not been submitted for publication within 18 months from study completion/termination at all participating sites, the PI shall have the right to single center publications provided they submit any data for presentation, oral or written, to the Sponsor for review 60 days prior to public disclosure. The PI may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER