A Phase 4 Open-Label Study Evaluating the Absorption and Systemic Pharmacokinetics of Topically Applied IDP-110 Gel (ACANYA™ Gel) in Subjects with Acne Vulgaris

• Conditions: 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; MedDRA version: 13.1Level: LLTClassification code 10000519Term: Acne vulgarisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders

• Registration Number: EUCTR2010-022678-15-DE
• Lead Sponsor: Dow Pharmaceutical Sciences, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10-26
• Last Update Posted: 10 December 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 16

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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified