| 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.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 19.0 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10037846 |
| E.1.2 | Term | Rash acneform |
| E.1.2 | System Organ Class | 100000004858 |
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| 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 objective of the study is to evaluate the efficacy and the local and systemic safety of 1% and 2% N-Acetyl-GED-0507-34-Levo gel, in comparison to the matching placebo gel, applied once daily for 12 weeks in patients with mild to moderate facial 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.Informed consent and assent: Written informed consent, before any study-related procedure, personally signed and dated by the patient if the patient is ≥ 18 years old, or signed and dated by the parent(s) or the legal guardian if the patient is 14 - <18 years old. An additional informed assent form must be signed by the subject if 14 - <18 years old to confirm his willingness to participate in the study. If the subject becomes 18 years of age during the study, the subject must provide written informed consent at that time to continue study participation
2.Sex and Age: Male and female patients aged 18-30 years old inclusive; only male patients aged 14 - <18 years old [14-20 years old (Juvenile Acne) and 21-30 (Acne Tarda)]
3.Race: White patients (i.e. people with European, Middle Eastern or North African ancestral origin)
4.Diagnosis: Patients with mild to moderate facial acne vulgaris with an investigator’s global assessment score of 2-3 at screening and baseline visits
5.Inflammatory lesions: Patients with ≤ 50 inflammatory lesions (papules, pustules, nodules) on the face (except the nose, that must have ≤ 10 inflammatory lesions) and ≤ 1 nodule
6.Non-inflammatory lesions: Patients with ≤ 50 non-inflammatory lesions (open and closed comedones) on the face (except the nose, that must have ≤ 10 non-inflammatory lesions)
7.Full comprehension: Subject and parent/guardian for < 18 years old subjects’ ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the investigator and to comply with the requirements of the entire study
8.Contraception and fertility (adult women, i.e. ≥ 18 years old; no female patients < 18 years old will be enrolled): Adult women of childbearing potential must be using at least one of the following reliable methods of contraception:
a.Hormonal oral, implantable, transdermal, or injectable contraceptives for at least 3 months before the screening visit
b.A non-hormonal intrauterine device [IUD] or female condom with spermicide or contraceptive sponge with spermicide or diaphragm with spermicide or cervical cap with spermicide for at least 2 months before the screening visit
c.A male sexual partner who agrees to use a male condom with spermicide
d.A sterile sexual partner
If National regulations require, only highly reliable contraception methods (i.e. hormonal, intrauterine device, sterilization) will be allowed at study entry. In that case, one-barrier methods will not be allowed.
In Countries where no such regulation is in place, contraception with one-barrier methods is also allowed. Female participants of non-childbearing potential will be admitted. For all female subjects, pregnancy test result must be negative at screening.
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| E.4 | Principal exclusion criteria |
1.Acne: Patients with spontaneously improving or rapidly deteriorating acne within at least 3 months before screening. Patients who have a known history of acne unresponsive to topical treatments. Patients with generalized or localized severe acne
2.Beard and facial hair: Patients who have a beard or who intend to grow a beard during the study. Subject has facial hair that could interfere with the study assessments in the opinion of the investigator
3.Skin diseases: Subjects with other active skin diseases (e.g. urticaria, atopic dermatitis) or skin infections (bacterial, fungal, or viral) that might interfere with the evaluation of acne, with the exception of footpad trichophytosis (athlete's foot) or common warts
4.Allergy: Known or suspected hypersensitivity to any active or inactive ingredient in the study products. Subjects with a history of an allergic reaction or significant sensitivity to the formulations’ ingredients
5.Topical therapies: Patients using, will use during the study, or discontinued less than 4 weeks before study baseline, prescribed or over-the counter topical therapies for the treatment of acne including but not limited to: corticosteroids, antibiotics, azelaic acid, benzoyl peroxide and retinoids.
6.Phototherapy: Patients using, will use during the study, or discontinued less than 12 weeks before study baseline, phototherapy for the treatment of acne including but not limited to: UV-A, UV-B, heliotherapy. Patients have the need or plan to be exposed to artificial tanning devices or excessive sunlight during the trial
7.Systemic therapies: Patients using, will use during the study, or discontinued less than 12 weeks before study baseline, systemic therapies for the treatment of acne including but not limited to: antibiotics, isotretinoin. Other systemic therapy which, in the opinion of the investigator, could affect the subject’s acne (Women on hormonal acne therapy can be enrolled if they have been on the hormonal therapy for at least 3 months before the screening visit and are anticipated to continue the hormonal therapy during the entire study).
8.Investigative studies: Participation in the evaluation of any investigational product or device within 30 days before study baseline
9.Diseases: Subject with underlying conditions (including, but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal) which in the opinion of the investigator could significantly immunocompromise the subject and/or place the subject at an unacceptable risk to receiving an immunomodulatory therapy. Any condition which in the investigator’s opinion would make it unsafe for the subject to participate in the study. Patients with Polycystic ovary syndrome
10.Alcohol and other substance abuse: History of alcohol or other substance abuse within one year before screening
11.Communication: Subject and parent/guardian (if applicable) unable to communicate or cooperate with the investigator due to e.g. language problems, impaired cerebral function, bad mental conditions
12.Reliability: Subject who may be unreliable for the study including subjects who are unable to return for the scheduled visits
13.Pregnancy (females only): Pregnant or breastfeeding women or planning to become pregnant during the study.
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| E.5 End points |
| E.5.1 | Primary end point(s) |
| Percentage of change from baseline in inflammatory lesions at week 12 |
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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) |
1) Absolute change from baseline in inflammatory lesions at week 12
2) Change from baseline (absolute and percentage) in inflammatory lesions at the other post-baseline assessment times
3) Change from baseline (absolute and percentage) in non-inflammatory lesions and total lesions (inflammatory plus non-inflammatory) at week 12 and at the other post-baseline assessment times
4) Proportion of subjects with an Investigator’s Global Assessment (IGA) score of “clear” (score=0) or “almost clear” (score=1) AND at least a two-score point reduction in IGA compared to baseline at week 12 and at the other post-baseline assessment times
5) Evaluation of safety, tolerability and local tolerability of the test treatments as compared to the matching placebo.
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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 | 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 | 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 | 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 | Yes |
| E.8.2.3 | Other | No |
| 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 | 6 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 20 |
| 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
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| The last subject last visit (LSLV) is defined as the last visit performed by the last study subject, i.e. the last visit foreseen by the study protocol, independently of the fact that the subject is a completer or a withdrawn subject. The end of the study will be the date of LSLV or the completion of any follow-up procedure. |
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| 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 | 9 |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial months | 9 |
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