Clinical trial NCT01531699: Antimicrobial Efficacy of ALT005 Ophthalmic Prep Solution in Healthy Volunteers
Official title: An Open-label Study to Assess the Antimicrobial Efficacy of ALT005 Ophthalmic Prep Solution (ALT005) Compared to Control (Sterile Saline) Following Dermal Administration in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infection Secondary to Surgical Procedure
Lead sponsor: Altacor Ltd.
Sponsor class: INDUSTRY
First posted: 2012-02-13
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is an open-label, randomized, single-dose, placebo-controlled efficacy study to assess the antimicrobial efficacy of ALT005 ophthalmic prep solution following dermal administration in healthy volunteers. Efficacy will be assessed by comparing the reduction in microbial load for up to 6 hours to that of saline control.

Detailed description: A total of 45 subjects who meet the criteria for inclusion will receive either ALT005 or control solution (sterile 0.9% saline) on one occasion to sites on the forehead and the cheeks. Subjects will be randomized in a ratio of 2:1 active:control. Subjects will be dosed in groups.

The study will run at one study center in the US. Subjects will be housed in the clinical research facility from the morning of Day -4 until the evening of Day 1. The total duration of participation for each subject dosed is approximately 21 days (from Day -19 study orientation through the follow-up call on Day 2, excluding the initial screening period).

In this study, the efficacy of ALT005 will be assessed in healthy volunteers who, after refraining voluntarily from using topical and oral antimicrobials for at least 2 weeks (14 days), exhibit acceptably high normal flora counts on the designated skin testing sites.

An additional cohort was added (3 ALT005, 6 Comparator Product) to make a non-statistical comparison of efficacy.

Eligibility criteria: Inclusion Criteria:

* Medically healthy with no clinically significant findings in the screening results
* Non-tobacco/nicotine-containing product users
* Acceptably high normal (\>3 log10) flora counts from the designated skin sites on Day -4.
* Voluntarily consent to participate in the study.
* Females reporting spontaneous postmenopausal status
* WOCBP must either be sexually inactive (abstinent) for 14 days prior to screening and remain so through 30 days following administration (topical dosing) of the study drug or have been using acceptable methods of birth control for the times specified
* WOCBP who have undergone sterilization procedures 6 months prior to Day 1

Exclusion Criteria:

* History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic (including sensitive skin on the face), neurological, or psychiatric disease, or any other clinically significant disease not deemed acceptable by the PI.
* Evidence of compromise to skin integrity of forehead or cheek caused by acute rash, exacerbation of dermatitis, exacerbation of acne, or any other acute condition deemed clinically significant by the PI.
* Tattoo, scar, keloid, or other chronic skin condition located on forehead or cheek
* Facial hair growth that would interfere with sample collection procedures.
* Positive urine drug/alcohol or cotinine testing
* Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCV).
* History or presence of alcoholism or drug abuse within the 2 years prior to Day 1.
* Hypersensitivity or idiosyncratic reaction to any ingredients in ALT005.
* Use of any prescription medication started within 90 days prior to Day 1
* Use of any over-the-counter (OTC) medication, including herbal products, within the 14 days prior to the Day 1
* Blood donation or significant blood loss within 56 days prior to Day 1
* Plasma donation within 7 days prior to Day 1
* Participation in another clinical trial within 30 days prior to Day 1
* Females who are pregnant or lactating, or have a positive pregnancy test at screening or check-in
* Failure to comply with the pre-treatment restrictions related to showering/washing and contact with antimicrobial substances.

Primary outcomes:
measure: 3 log10 reduction in microbial load
timeFrame: 10 minutes post dose
Secondary outcomes:
measure: 3 log10 reduction in microbial load
timeFrame: 45 minutes post dose
measure: 3 log10 reduction in microbial load
timeFrame: 6 hours post dose
Other outcomes:
Locations:
city: Neptune
country: United States
facility: Celerion Inc
state: New Jersey
Study officials:
affiliation: Celerion
name: Sandra Connolly, MD
role: PRINCIPAL_INVESTIGATOR
References: