E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10003639 |
E.1.2 | Term | Atopic dermatitis |
|
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 |
Evaluate the efficacy of CD4802 ointment 0.1% over 4 weeks versus vehicle on target lesions in adult patients with atopic dermatitis. |
|
E.2.2 | Secondary objectives of the trial |
Evaluate the safety of CD4802 ointment 0.1% in patients with atopic dermatitis: - Local tolerance by AEs, - Systemic tolerance by AEs, vital signs, laboratory tests
Characterize the pathology and response to treatment by proteomic and genomic analysis conducted on skin strippings and saliva samplings, respectively. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- The subject is a male or female 18 years of age or older,
- The subject is a female of non-childbearing potential, e.g. postmenopausal (absence of menstrual bleeding for 2 years), or had a hysterectomy or bilateral ovariectomy,
- The subject has a clinical diagnosis of chronic atopic dermatitis according to Hanifin and Rajka (1980), mild to moderate in intensity as defined by Langeland and Rajka (1989).
- The subject presents at least 2 symmetric plaques which: - Are representative of the subject’s disease state, - Are of similar severity, - Represent a surface comprised between 10 and 30 cm² (+/- 2) - Are not located on the hands, feet, genitalia or face, - Present a total score of at least 5/15 (total score defined as the sum of erythema, oedema/papulation, excoriation, lichenification, and oozing/crusting graded on a scale of 0 to 3 (maximum total score = 15)
|
|
E.4 | Principal exclusion criteria |
- Underlying disease, which, in the investigator’s opinion would put the subject at risk (e.g., uncontrolled chronic or serious diseases which would normally prevent participation in any clinical trial such as cancer, AIDS, severe cardiopathy, renal or hepatic impairment…)
- Underlying dermatological disease, which, in the investigator’s opinion, may confound the study assessment (e.g., other dermatological diseases affecting the treatment areas, such as psoriasis, severe ichtyosis, exfoliative erythrodermia, impetiginized atopic dermatitis…)
- Corrected serum calcium concentration above upper normal range at screening visit
- Calcium/creatinine ratio in urines above upper normal range at screening visit
- History/signs/symptoms suggestive of an abnormality of calcium homeostasis (such as hyperparathyroidism, Paget’s disease, adrenal insufficiency, hyperthyroidism…),
- History/signs/symptoms of urinary stones,
- History of cancer including skin cancer,
- Positive HIV, HBV or HCV serology,
- Clinically significant abnormalities discovered in the blood and urinary tests performed at the screening visit,
- Planned exposure to sun or ultraviolet light during the study
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
The primary criterion is the Area under the curve (AUC) for Total Sum Score (sum of individual clinical scores: erythema + excoriation + oedema/papulation + oozing/crusting + lichenification) calculated from D 1/Baseline (before application) up to D29 by subject and by treatment, using the trapezoidal rule.
|
|
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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
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 | Yes |
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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Intra individual (right versus left) |
|
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | |