| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
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| E.1.1.1 | Medical condition in easily understood language |
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| E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
| MedDRA Classification |
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | 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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| E.2.2 | Secondary objectives of the trial |
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| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
1. Subject is male or female 12 years of age or older at the time of consent.
2. Subject has provided written and verbal informed consent/assent. A subject under 18 years of age 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 informed, consent for the subject. If a subject becomes 18 years of age during the study the subject must provide written informed consent at the next study visit to continue study participation.
3. Females must be post-menopausal, surgically sterile or using highly effective birth control methods with a negative urine pregnancy test at the Screening and Baseline Visits.
4. Subject has moderate to severe facial acne vulgaris (Grade 3 to 4) as determined by the Investigator’s Global Assessment (IGA) [0 (clear) to 4 (severe) scale] and obvious acne on the chest and/or back at the Screening Visit.
5. Subject has facial acne vulgaris (including the nose) with a minimum of 20 inflammatory lesions (papules, pustules, and nodules/cysts) and a minimum of 20 non-inflammatory lesions (open and closed comedones) at the Screening Visit.
6. Subject must be in general good health in the opinion of the investigator, with normal renal function as defined per protocol, based on screening physical examination (defined as the absence of any clinically relevant abnormalities), medical history, and clinical laboratory values (hematology, serum chemistry and urinalysis).
7. Subject has normal response to cosyntropin stimulation defined as a Screening CST with a 30-minute post-stimulation cortisol level of > 18 μg/dL.
8. Subject is able to communicate with the staff and is willing to comply with study instructions, reside at and/or return to the clinic for required visits. |
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| E.4 | Principal exclusion criteria |
1. Subject is pregnant, lactating, or is planning to become pregnant during the study.
2. Subject is 12- to < 18 years of age and has a Body Mass Index (BMI) for age percentile > 95%.
3. Subject is > 18 years of age and has a BMI > 32.0 kg/m2.
4. Subject reported use of tobacco, smoking cessation products, or products containing nicotine within three (3) months prior to Screening.
5. Except for the use of contraceptives, subject reported use of any prescription drug or herbal product within 14 days prior to dosing, any non- prescription drug or vitamin or mineral supplements within 7 days prior to dosing; any known enzyme-inducer, enzyme-inhibitor, or reported chronic exposure to enzyme inducers such as paint solvents or pesticides within 30 days of Baseline.
6. Subject has used topical anti-acne medications containing retinoids such as tazarotene, adapalene, tretinoin, within four (4) weeks of Baseline.
7. Subject has used the following systemic anti-acne medications: antibiotics within two (2) weeks of Baseline, spironolactone within four (4) weeks of Baseline, or retinoid therapy within three (3) months of Baseline.
8. Subject 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.
9. Subject has any condition which, in the investigator’s opinion, would make it unsafe for the subject to participate in this research study.
10. Subject has the need or plans to be exposed to artificial tanning devices or excessive sunlight during the study.
11. Subject has used light treatments, microdermabrasion or chemical peels to the face, chest and back within eight (8) weeks of Visit 2 (Baseline).
12. Subject cannot avoid any type of strenuous exercise (swimming, running, team sports, etc.,) or the use of hot tubs/saunas from Visit 2 (Baseline) to the end of the study (Visit 5).
13. Subject has any clinically significant medical abnormality or chronic disease of the cardiovascular, gastrointestinal, respiratory (e.g., chronic obstructive pulmonary disease), hepatic, or renal systems. This includes conditions (e.g., gastrointestinal surgery) that may interfere with metabolism, or excretion.
14. Subject has a history of alcohol and/or drug abuse in the investigator's judgment or has a positive urine drug screen result at the Screening Visit.
15. Subject is unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function.
16. Subject is known to be hypersensitive to the test article or any components in the test article.
17. Subject has received an investigational drug or been treated with an investigational device within 30 days prior to Visit 2 (Baseline).
18. Subject is currently enrolled in an investigational drug or device study.
19. Subject has used topical corticosteroids (including inhaled and intranasal corticosteroids) within two weeks of the Cosyntropin Stimulation Test (CST) at the Screening Visit and/or between the Screening CST and Baseline.
20. Subject has used systemic corticosteroids (including intramuscular and intralesional injections) within four (4) weeks of the CST at the Screening Visit and/or between the Screening CST and Baseline.
21. Subject has an irregular sleep schedule or works night shifts (cortisol levels exhibit physiological diurnal variation).
22. Subject has experienced significant blood loss within 60 days or has donated plasma within 72 hours prior to Visit 2 (Baseline).
23. Subject tests positive at screening for human immunodeficiency virus (HIV) or is known to be seropositive for HIV.
24. Subject tests positive at Screening for hepatitis B surface antigen, hepatitis C antibody or has a history of a positive result.
25. Subject had major surgery within 30 days prior to Visit 2 (Baseline) or plans to have surgery during the study.
26. Subject has participated in a previous CB-03-01 study. |
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| E.5 End points |
| E.5.1 | Primary end point(s) |
• HPA Axis Response to Cosyntropin - Measurement of serum cortisol concentrations after stimulation of the adrenal cortex with Cosyntropin (CST) at Screening, and Day 14 (or EOS). HPA axis suppression is defined as a post-stimulation serum cortisol level < 18 μg/dL at Day 14 (or EOS).
• Concentration-time profiles of cortexolone 17α-propionate and cortexolone in plasma after a) first dose and b) after the last dose on Day 14. |
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| E.5.1.1 | Timepoint(s) of evaluation of this end point |
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| E.5.2 | Secondary end point(s) |
• Clinical laboratory testing (hematology, clinical chemistry, and urinalysis) at Screening and Day 14 (or EOS).
• Local and systemic adverse events – every visit (Baseline, Days 5, 10 and 14).
• The presence (and severity) of the following local skin reactions: telangiectasia, skin atrophy, striae rubrae, erythema, edema, scaling/dryness, stinging/burning and pruritus will be documented at Baseline, Days 5, 10 and 14.
• Physical examination/vital signs at Screening and Day 14 (or EOS).
• Urine pregnancy testing in all women who are not post-menopausal or surgically sterile at Screening, Baseline, and Day 14.
• ECG at Screening and end of study. |
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| E.5.2.1 | Timepoint(s) of evaluation of this end point |
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| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | Yes |
| E.6.4 | Safety | No |
| E.6.5 | Efficacy | No |
| E.6.6 | Pharmacokinetic | Yes |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | Yes |
| E.7.3 | Therapeutic confirmatory (Phase III) | No |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | No |
| E.8.1.1 | Randomised | No |
| E.8.1.2 | Open | Yes |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | No |
| E.8.1.5 | Parallel group | No |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | No |
| E.8.2.2 | Placebo | No |
| E.8.2.3 | Other | No |
| E.8.2.4 | Number of treatment arms in the trial | 1 |
| E.8.3 |
Will this trial be conducted at a single site globally?
| No |
| E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
| E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
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| E.8.7 | Trial has a data monitoring committee | No |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.2 | In all countries concerned by the trial months | 6 |
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