E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Male or female of any race, at least 18 years of age with a clinical diagnosis of acne vulgaris with a score of 3 (moderate) or 4 (severe) on the Evaluator’s Global Severity Score (EGSS) assessment
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 13.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10000519 |
E.1.2 | Term | Acne vulgaris |
E.1.2 | System Organ Class | 10040785 - Skin and subcutaneous tissue disorders |
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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 |
To evaluate the safety, systemic exposure and pharmacokinetics of clindamycin in IDP-110 Gel (clindamycin phosphate 1.2% and benzoyl peroxide 2.5%) in subjects with moderate or severe acne vulgaris during once daily topical application of IDP-110 Gel for 30 days. |
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E.2.2 | Secondary objectives of the trial |
in addition dermal tolerance will be assessed |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.Male or female of any race, at least 18 years of age; 2.Verbal and signed written informed consent obtained from the subject; 3.Has a clinical diagnosis of acne vulgaris with a score of 3 (moderate) or 4 (severe) on the EGSS assessment at the Screening and Day 0 Visits; 4.Presence of 17 to 40 inflammatory lesions (papules, pustules, and nodules) on the face (excluding the nose) at the Screening and Day 0 Visits; 5.Presence of 20 to 100 non-inflammatory lesions (open and closed comedones) on the face (excluding the nose) at the Screening and Day 0 Visits; 6.If female of childbearing potential, has a negative urine pregnancy test at the Screening and Day 0 visits, and must be willing to use an effective method of contraception during the study. Effective contraception is defined as a failure rate of less than 1 % per year when used consistently and correctly such as some intrauterine devices (IUD), condom with spermicide, diaphragm with spermicide, or stable use of a hormonal contraceptive (oral, implant, injection or transdermal patch) for at least 3 months prior to the Screening visit. (Females using birth control pills must have taken the same type of pill for at least 3 months prior to entering the study and must not change type during the study. Those who have used birth control pills in the past must have discontinued usage at least 3 months prior to study entry); 7.Subject is willing to comply with study instructions and return to the clinic for all required visits; 8.Subjects must agree not to change their usual moisturizers, sunscreens, or moisturizer/sunscreen combination products during the study.
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E.4 | Principal exclusion criteria |
Presence of more than 2 nodules or cysts on the face; Female who is pregnant, nursing an infant, or planning a pregnancy during the study period; Presence of a surgical or medical condition that, in the judgement of the Investigator, might interfere with the absorption, distribution, metabolism, or excretion of the study drug; Presence of any other dermatological condition on the face that could interfere with the study evaluations Treatment with any investigational drug or device within 30 days or 5 half-lives (whichever is longer) prior to the Screening Visit, or concurrent participation in another clinical study with an investigational drug or device; Any underlying disease(s) or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion count inconclusive; Evidence or history of cosmetic-related acne; History of experiencing significant burning or stinging when applying any facial treatment (e.g., make-up, soap, masks, washes, sunscreens, etc) to their face; Use of medical products as described under point 10.4. of the protocol If female, subject has a history of hirsutism, polycystic ovarian disease or clinically significant menstrual irregularities; History of gastrointestinal disieases as described in the protocol; Treatment with antiperistaltic agents such as opiates and diphenoxylate with atropine within four weeks prior to the first administration of investigational drug in this study and during the study; Treatment of any type of cancer within the last 6 months; Subject intends to use a tanning booth or sunbathe during the study; Subject is unable to communicate or cooperate with the Investigator due to language problems, poor mental development, or impaired cerebral function; Subject with any underlying disease that the Investigator deems uncontrolled, and poses a concern for the subject’s safety while participating on the study; Subject has donated blood within 3 months prior to Day 0 or plans to donate blood during the study.
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E.5 End points |
E.5.1 | Primary end point(s) |
Plasma concentrations of clindamycin |
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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 | 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) | Yes |
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 | 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.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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
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end of trial is the lasr visit of last subject |
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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 | 3 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 3 |