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: 13.1 Level: LLT Classification code 10000519 Term: Acne vulgaris System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Trade Name: ACANYA™ Gel
Product Name: ACANYA™ Gel
Pharmaceutical Form: Gel
INN or Proposed INN: clindamycin phosphate 1.2%
CAS Number: 18323449
Concentration unit: % percent
Concentration type: equal
Sponsors
Dow Pharmaceutical Sciences, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: in addition dermal tolerance will be assessed ;Primary end point(s): Plasma concentrations of clindamycin | — |
Countries
Germany
Outcome results
None listed