Clinical Trial Results:
An Open Label Evaluation of the Adrenal Suppression Potential and Pharmacokinetic Properties of Cortexolone 17α-Propionate (CB-03-01) Cream Applied Every 12 Hours for Two Weeks in Subjects with Acne Vulgaris
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Summary
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EudraCT number |
2023-000462-33 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
11 Nov 2013
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Results information
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Results version number |
v1(current) |
This version publication date |
27 May 2023
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First version publication date |
27 May 2023
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
171-7151-202
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01831960 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Intrepid Therapeutics Inc.
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Sponsor organisation address |
12463 Rancho Bernardo Road, #537, San Diego, United States, CA 92128-2143
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Public contact |
Cassiopea SpA, Cosmo SpA, +39 02868 91124, dermatology@cosmopharma.com
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Scientific contact |
Cassiopea SpA, Cosmo SpA, +39 02868 91124, dermatology@cosmopharma.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
Yes
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EMA paediatric investigation plan number(s) |
EMEA-003330-PIP01-22 | ||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
08 Apr 2014
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
11 Nov 2013
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Global end of trial reached? |
Yes
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Global end of trial date |
11 Nov 2013
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The primary objectives of this study are to determine a) the adrenal suppression potential and b) the pharmacokinetic (PK) properties of CB-03-01 Cream, 1% in subjects with acne vulgaris
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Protection of trial subjects |
Approval on the conduct of the trial was obtained by an IRB and by the FDA prior to study initiation. The study protocol, consent/assent form, participant recruitment materials/process, and other relevant documents were submitted for approval in compliance with the requirements set forth in Title 21 of the Code of Federal Regulations (CFR), Parts 56.107 to 56.115. The study was conducted in accordance with principles of the Declaration of Helsinki, with the current Good Clinical Practice (GCP) Guideline and with other applicable regulations.
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Background therapy |
No background therapy was planned | ||
Evidence for comparator |
No comparators were used in the study | ||
Actual start date of recruitment |
07 May 2013
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United States: 42
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Worldwide total number of subjects |
42
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EEA total number of subjects |
0
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
22
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Adults (18-64 years) |
20
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
- | |||||||||
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Pre-assignment
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Screening details |
57 subjects were screened for the study; 42 subjects (20 adults in Cohort 1 and 22 adolescents in Cohort 2) were enrolled into the study; 15 subjects were screen failures. | |||||||||
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Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | |||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Cortexolone 17α-Propionate (Cohort 1) | |||||||||
Arm description |
Cohort 1 enrolled adult subjects. | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Cortexolone 17α-Propionate
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Cream
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Routes of administration |
Topical use
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Dosage and administration details |
Topical cream, 1.0% concentration, applied every twelve hours.
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Arm title
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Cortexolone 17α-Propionate (Cohort 2) | |||||||||
Arm description |
Cohort 2 enrolled adolescent subjects 12 to less than 18 years of age. | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Cortexolone 17α-Propionate
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Cream
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Routes of administration |
Topical use
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Dosage and administration details |
Topical cream, 1.0% concentration, applied every twelve hours.
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Baseline characteristics reporting groups
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Reporting group title |
Cortexolone 17α-Propionate (Cohort 1)
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Reporting group description |
Cohort 1 enrolled adult subjects. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Cortexolone 17α-Propionate (Cohort 2)
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Reporting group description |
Cohort 2 enrolled adolescent subjects 12 to less than 18 years of age. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Cortexolone 17α-Propionate (Cohort 1)
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Reporting group description |
Cohort 1 enrolled adult subjects. | ||
Reporting group title |
Cortexolone 17α-Propionate (Cohort 2)
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Reporting group description |
Cohort 2 enrolled adolescent subjects 12 to less than 18 years of age. | ||
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End point title |
Change in HPA Axis Response to Cosyntropin [1] | ||||||||||||||||||||||||
End point description |
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.
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End point type |
Primary
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End point timeframe |
Baseline and Day 14
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: All analyses were descriptive. Serum cortisol results were summarized for evaluable subjects. HPA axis responses to CST were dichotomized to normal and abnormal. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||
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End point title |
PK Profiles (Cmax) of Cortexolone 17α-propionate [2] | ||||||||||||||||||
End point description |
Max 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).
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End point type |
Primary
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End point timeframe |
Baseline and Day 14
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| Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: All analyses were descriptive and of exploratory nature. If p-values or confidence intervals (CI) were presented, they were to be interpreted descriptively. Non-compartmental analysis was used for estimation of PK parameters. |
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
PK Profiles (AUC) of Cortexolone 17α-propionate [3] | ||||||||||||||||||
End point description |
Area 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]).
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End point type |
Primary
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End point timeframe |
Baseline and Day 14
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| Notes [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: All analyses were descriptive and of exploratory nature. If p-values or confidence intervals (CI) were presented, they were to be interpreted descriptively. Non-compartmental analysis was used for estimation of PK parameters. |
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
PK Profiles (Cavg) of Cortexolone 17α-propionate [4] | ||||||||||||||||||
End point description |
Average 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).
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End point type |
Primary
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End point timeframe |
Baseline and Day 14
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| Notes [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: All analyses were descriptive and of exploratory nature. If p-values or confidence intervals (CI) were presented, they were to be interpreted descriptively. Non-compartmental analysis was used for estimation of PK parameters. |
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| No statistical analyses for this end point | |||||||||||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
14 days
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Adverse event reporting additional description |
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.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
16.0
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Reporting groups
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Reporting group title |
Cortexolone 17α-Propionate (Cohort 1)
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Reporting group description |
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Reporting group title |
Cortexolone 17α-Propionate (Cohort 2)
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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13 Feb 2013 |
Protocol Amendment #1 |
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11 Jun 2013 |
Protocol Amendment #2 |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
