E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
E.1.1.1 | Medical condition in easily understood language |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.0 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10040785 |
E.1.2 | Term | Skin and subcutaneous tissue disorders |
E.1.2 | System Organ Class | 10040785 - Skin and subcutaneous tissue disorders |
|
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 main objective of the study is to evaluate the effect of a supplementary patient education intervention (in addition to the standard-of-care patient eduction) on treatment adherence and satisfaction among acne patients receiving once daily Epiduo Gel treatment in primary carec clinics. |
|
E.2.2 | Secondary objectives of the trial |
The secondary objective is to compare the change in treatment adherence linked to supplementary patient eduction with the change in treatment adherence linked to more frequent clinic visits, as it has been shown that more frequent clinic visits can improve patients adherence to topical acne treatments. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.Male or female subjects age of 12 years or older,
2.With facial acne vulgaris that can be managed in primary care,
3.Female subjects of childbearing potential with a negative urine pregnancy test (UPT) at Baseline visit,
4.Female subjects of childbearing potential must practice a highly effective method of contraception during the study: medical contraception (combined oral contraceptives [estrogens and progesterone] or implanted or injectable contraceptives with stable dose for at least 1 month prior to study entry), bilateral tubal ligation, hormonal intrauterine device (inserted at least 1 month prior to study entry), strict abstinence (at least 1 month prior to study entry and agree to continue for the duration of the study), or vasectomized partner (at least 3 months prior to study entry),
5.Females of non-childbearing potential, e.g., premenses, post-menopausal (absence of menstrual bleeding for 1 year prior to study entry), hysterectomy, or bilateral ovariectomy,
6.Subjects willing and capable of complying with the extent and degree required by the protocol,
7.Subjects or the parents/legal guardians (for subjects of 12-17 years old) understand and sign the Informed Consent Form (ICF) at Baseline, prior to any investigational procedure being performed.
|
|
E.4 | Principal exclusion criteria |
1.Female subjects who are pregnant, nursing or planning a pregnancy during the study,
2.Subjects have acne on their chest and/or back,
3.Subjects have a very severe variant of acne such as fulminating acne with systemic symptoms (acne fulminans),
4.Subjects with severe acne or painful, deep nodules or cysts (nodulocystic acne),
5.Subjects with severe social or psychological problems including a morbid fear of deformity (dysmorphophobia),
6.Subjects are at risk of, or are developing, scarring despite primary care therapies,
7.Subjects have moderate acne that has failed to respond to treatment which should generally include several courses of both topical and systemic treatment over a period of at least 6 months,
8.Subjects are suspected of having an underlying endocrinological cause for the acne (such as polycystic ovary syndrome) that needs assessment,
9.Subjects currently taking any other acne treatments,
10.Subjects with known impaired hepatic or renal functions
11.Subjects with known intolerance to lactose,
12.Subjects with a condition or who are in a situation which, in the investigator’s opinion, may put the subject at risk, confound the study results, or interfere with the subject’s participation in the study,
13.Subjects who are at risk in terms of precautions, warnings, and contraindications (see package inserts),
14.Subjects with known or suspected allergies or sensitivities to any component of the study drug (see package inserts),
15.Subjects who have participated in another investigational drug or device research study within 30 days of enrolment of this study,
16.Subjects of 12-17 years for whom the signed ICF from their parents/legal guardians is not obtained,
17.Subjects under guardianship, hospitalised subjects in a public or private institution for a reason other than the research, and subjects deprived of their freedom
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Subjects adherence to treatment:
-% adherence per week and throughout the study based on MEMS (an electronic system to monitor the opening and closing of medication)
-% good adherence according to ECOB questionnaire throughout the study
- quantity of product used during the first and second 6-weeks period and throughout the study |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
- Efficacy based on Global Assessment of Improvement evaluated by both investigator and subjects at Week 6 and last visit
- Safety based on incidence of Adverse Event
- Quality-of-Life and satisfaction based on questionnaire |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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 | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Treatment adherence and patient satisfaction |
|
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
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 | Yes |
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 | Yes |
E.8.2.3.1 | Comparator description |
Different patient education interventions |
|
E.8.2.4 | Number of treatment arms in the trial | 3 |
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 | 10 |
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 | No |
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
|
Last visit of the last subject |
|
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 | 7 |
E.8.9.1 | In the Member State concerned days | 17 |
E.8.9.2 | In all countries concerned by the trial months | 7 |
E.8.9.2 | In all countries concerned by the trial days | 17 |