Trial Outcomes & Findings for An Evaluation of the Adrenal Suppression Potential and Pharmacokinetic Properties of CB-03-01 Cream in Subjects With Acne Vulgaris (NCT NCT01831960)
NCT ID: NCT01831960
Last Updated: 2020-12-02
Results Overview
Measurement of serum cortisol concentrations after stimulation of the adrenal cortex with cosyntropin injection (Cosyntropin Stimulation Test - CST). Prior to CST, a pre-CST blood sample is taken between 7AM to 9AM. Thirty minutes after CST, a post-CST blood sample is collected. 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
42 participants
Primary outcome timeframe
Baseline and Day 14
Results posted on
2020-12-02
Participant Flow
Participant milestones
| Measure |
Cortexolone 17α-Propionate (Cohort 1)
Cohort 1 enrolled adult subjects. Topical cream, 1.0% concentration, applied every twelve hours.
|
Cortexolone 17α-Propionate (Cohort 2)
Cohort 2 enrolled adolescent subjects 12 to less than 18 years of age. Topical cream, 1.0% concentration, applied every twelve hours.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
22
|
|
Overall Study
COMPLETED
|
20
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Forty-two (42) subjects were enrolled into the study across two cohorts dependent upon age: Cohort 1: 20 adult subjects Cohort 2: 22 adolescent (12 to less than 18 years of age) subjects
Baseline characteristics by cohort
| Measure |
Cortexolone 17α-Propionate (Cohort 1)
n=20 Participants
Topical cream, 1.0% concentration, applied every twelve hours.
|
Cortexolone 17α-Propionate (Cohort 2)
n=22 Participants
Cohort 2 enrolled adolescent subjects 12 to less than 18 years of age. Topical cream, 1.0% concentration, applied every twelve hours.
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
24.4 years
STANDARD_DEVIATION 5.84 • n=93 Participants • Forty-two (42) subjects were enrolled into the study across two cohorts dependent upon age: Cohort 1: 20 adult subjects Cohort 2: 22 adolescent (12 to less than 18 years of age) subjects
|
15.6 years
STANDARD_DEVIATION 1.33 • n=4 Participants • Forty-two (42) subjects were enrolled into the study across two cohorts dependent upon age: Cohort 1: 20 adult subjects Cohort 2: 22 adolescent (12 to less than 18 years of age) subjects
|
19.8 years
STANDARD_DEVIATION 6.02 • n=27 Participants • Forty-two (42) subjects were enrolled into the study across two cohorts dependent upon age: Cohort 1: 20 adult subjects Cohort 2: 22 adolescent (12 to less than 18 years of age) subjects
|
|
Sex: Female, Male
Female
|
15 Participants
n=93 Participants • See note above.
|
12 Participants
n=4 Participants • See note above.
|
27 Participants
n=27 Participants • See note above.
|
|
Sex: Female, Male
Male
|
5 Participants
n=93 Participants • See note above.
|
10 Participants
n=4 Participants • See note above.
|
15 Participants
n=27 Participants • See note above.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants • See note above.
|
1 Participants
n=4 Participants • See note above.
|
1 Participants
n=27 Participants • See note above.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=93 Participants • See note above.
|
21 Participants
n=4 Participants • See note above.
|
41 Participants
n=27 Participants • See note above.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants • See note above.
|
0 Participants
n=4 Participants • See note above.
|
0 Participants
n=27 Participants • See note above.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants • See note above.
|
0 Participants
n=4 Participants • See note above.
|
0 Participants
n=27 Participants • See note above.
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants • See note above.
|
0 Participants
n=4 Participants • See note above.
|
1 Participants
n=27 Participants • See note above.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants • See note above.
|
0 Participants
n=4 Participants • See note above.
|
0 Participants
n=27 Participants • See note above.
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants • See note above.
|
0 Participants
n=4 Participants • See note above.
|
1 Participants
n=27 Participants • See note above.
|
|
Race (NIH/OMB)
White
|
17 Participants
n=93 Participants • See note above.
|
21 Participants
n=4 Participants • See note above.
|
38 Participants
n=27 Participants • See note above.
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=93 Participants • See note above.
|
1 Participants
n=4 Participants • See note above.
|
2 Participants
n=27 Participants • See note above.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants • See note above.
|
0 Participants
n=4 Participants • See note above.
|
0 Participants
n=27 Participants • See note above.
|
PRIMARY outcome
Timeframe: Baseline and Day 14Measurement of serum cortisol concentrations after stimulation of the adrenal cortex with cosyntropin injection (Cosyntropin Stimulation Test - CST). Prior to CST, a pre-CST blood sample is taken between 7AM to 9AM. Thirty minutes after CST, a post-CST blood sample is collected. HPA axis suppression is defined as a post-stimulation serum cortisol level ≤ 18 μg/dL at Day 14.
Outcome measures
| Measure |
Cortexolone 17α-Propionate (Cohort 1)
n=20 Participants
Cohort 1 enrolled adults subjects. Topical cream, 1.0% concentration, applied every twelve hours.
|
Cortexolone 17α-Propionate (Cohort 2)
n=22 Participants
Cohort 2 enrolled adolescent subjects 12 to less than 18 years of age. Topical cream, 1.0% concentration, applied every twelve hours.
|
|---|---|---|
|
Change in HPA Axis Response to Cosyntropin
Baseline (pre-CST)
|
17.0 mcg/dL
Standard Deviation 5.98
|
16.8 mcg/dL
Standard Deviation 4.71
|
|
Change in HPA Axis Response to Cosyntropin
Baseline (post-CST)
|
27.7 mcg/dL
Standard Deviation 3.43
|
24.6 mcg/dL
Standard Deviation 3.12
|
|
Change in HPA Axis Response to Cosyntropin
Day 14 (pre-CST)
|
18.1 mcg/dL
Standard Deviation 7.02
|
15.4 mcg/dL
Standard Deviation 3.98
|
|
Change in HPA Axis Response to Cosyntropin
Day 14 (post-CST)
|
26.7 mcg/dL
Standard Deviation 5.56
|
22.8 mcg/dL
Standard Deviation 2.99
|
PRIMARY outcome
Timeframe: Baseline and Day 14Max concentration (Cmax) of cortexolone 17α-propionate in plasma following the first application (i.e., Day 1, 0-12 hours) and last application (i.e., Day 14, 0-12 hours).
Outcome measures
| Measure |
Cortexolone 17α-Propionate (Cohort 1)
n=20 Participants
Cohort 1 enrolled adults subjects. Topical cream, 1.0% concentration, applied every twelve hours.
|
Cortexolone 17α-Propionate (Cohort 2)
n=22 Participants
Cohort 2 enrolled adolescent subjects 12 to less than 18 years of age. Topical cream, 1.0% concentration, applied every twelve hours.
|
|---|---|---|
|
PK Profiles (Cmax) of Cortexolone 17α-propionate
Cmax - Day 1 (ng/mL)
|
3.23 ng/mL
Standard Deviation 2.01
|
3.58 ng/mL
Standard Deviation 4.30
|
|
PK Profiles (Cmax) of Cortexolone 17α-propionate
Cmax - Day 14 (ng/mL)
|
4.46 ng/mL
Standard Deviation 3.00
|
4.61 ng/mL
Standard Deviation 4.74
|
PRIMARY outcome
Timeframe: Baseline and Day 14Area under the plasma concentration curve (0-12 hours) of cortexolone 17α-propionate at baseline (i.e., Day 1, after first application \[0-12 hours\]) and at Day 14 (i.e., Day 14, after last application \[0-12 hours\]).
Outcome measures
| Measure |
Cortexolone 17α-Propionate (Cohort 1)
n=20 Participants
Cohort 1 enrolled adults subjects. Topical cream, 1.0% concentration, applied every twelve hours.
|
Cortexolone 17α-Propionate (Cohort 2)
n=22 Participants
Cohort 2 enrolled adolescent subjects 12 to less than 18 years of age. Topical cream, 1.0% concentration, applied every twelve hours.
|
|---|---|---|
|
PK Profiles (AUC) of Cortexolone 17α-propionate
AUCτ - Day 1
|
22.02 hr*ng/mL
Standard Deviation 13.67
|
22.55 hr*ng/mL
Standard Deviation 22.57
|
|
PK Profiles (AUC) of Cortexolone 17α-propionate
AUCτ - Day 14
|
37.14 hr*ng/mL
Standard Deviation 22.92
|
30.97 hr*ng/mL
Standard Deviation 24.65
|
PRIMARY outcome
Timeframe: Baseline and Day 14Average concentration of cortexolone 17α-propionate in plasma calculated as the ratio of the AUC(0-12 hours) and the dosing interval (i.e., 12 hours) at baseline (i.e., Day 1, after first application) and at Day 14 (after last application).
Outcome measures
| Measure |
Cortexolone 17α-Propionate (Cohort 1)
n=20 Participants
Cohort 1 enrolled adults subjects. Topical cream, 1.0% concentration, applied every twelve hours.
|
Cortexolone 17α-Propionate (Cohort 2)
n=22 Participants
Cohort 2 enrolled adolescent subjects 12 to less than 18 years of age. Topical cream, 1.0% concentration, applied every twelve hours.
|
|---|---|---|
|
PK Profiles (Cavg) of Cortexolone 17α-propionate
Cavg - Day 1
|
1.84 ng/mL
Standard Deviation 1.14
|
1.88 ng/mL
Standard Deviation 1.88
|
|
PK Profiles (Cavg) of Cortexolone 17α-propionate
Cavg - Day 14
|
3.10 ng/mL
Standard Deviation 1.91
|
2.58 ng/mL
Standard Deviation 2.05
|
Adverse Events
Cortexolone 17α-Propionate (Cohort 1)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cortexolone 17α-Propionate (Cohort 2)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cortexolone 17α-Propionate (Cohort 1)
n=20 participants at risk
Cohort 1 enrolled adults subjects. Topical cream, 1.0% concentration, applied every twelve hours.
|
Cortexolone 17α-Propionate (Cohort 2)
n=22 participants at risk
Cohort 2 enrolled adolescent subjects 12 to less than 18 years of age. Topical cream, 1.0% concentration, applied every twelve hours.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
5.0%
1/20 • Number of events 1 • 14 Days
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.
|
0.00%
0/22 • 14 Days
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.
|
|
General disorders
Application site folliculitis
|
5.0%
1/20 • Number of events 1 • 14 Days
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.
|
0.00%
0/22 • 14 Days
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.
|
|
Infections and infestations
Ear infection
|
0.00%
0/20 • 14 Days
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.
|
4.5%
1/22 • Number of events 1 • 14 Days
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.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.0%
1/20 • Number of events 1 • 14 Days
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.
|
4.5%
1/22 • Number of events 1 • 14 Days
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.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
5.0%
1/20 • Number of events 1 • 14 Days
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.
|
0.00%
0/22 • 14 Days
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.
|
|
Investigations
ACTH stimulation test abnormal
|
5.0%
1/20 • Number of events 1 • 14 Days
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.
|
9.1%
2/22 • Number of events 2 • 14 Days
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.
|
Additional Information
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