- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02062073
Dermal Safety Study to Evaluate the Sensitizing Potential of Abametapir Lotion
April 27, 2020 updated by: Dr. Reddy's Laboratories Limited
A Randomized, Controlled Study to Evaluate the Sensitizing Potential of Abametapir Lotion in Healthy Volunteers Using a Repeat Insult Patch Test Design
Purpose of this study will be to determine the potential of abametapir lotion to induce sensitization by repeated topical application to the healthy skin of humans under controlled conditions.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
238
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New Jersey
-
Paramus, New Jersey, United States, 07652
- TKL Reserach
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Are healthy (to be confirmed by medical history) males or females, 18 years of age or older;
- In the case of females of childbearing potential, are using an acceptable form of birth control (oral/implant/injectable/transdermal contraceptives, intrauterine device, condom with spermicide, diaphragm with spermicide, abstinence, partner's vasectomy). Abstinence or vasectomized partner are acceptable if the female subject agrees to implement one of the other acceptable methods of birth control if her lifestyle/partner changes;
- If female of childbearing potential, have a negative urine pregnancy test at Day 1, and are willing to submit to a pregnancy test at the end of study;
- Are free of any systemic or dermatologic disorder, which, in the opinion of the investigator, will interfere with the study results or increase the risk of adverse events;
- Are of any skin type or race, providing the skin pigmentation will allow discernment of erythema;
- Complete a patch study Medical Screening form as well as a Medical Personal History form; and
- Read, understand, and provide signed informed consent.
Exclusion Criteria:
- Have any visible skin disease at the application site which, in the opinion of the investigative personnel, will interfere with the evaluation of the test site reaction;
- Are not willing to refrain from using topical/systemic analgesics such as aspirin (daily use of 81 mg aspirin is acceptable), Aleve, Motrin, Advil, or Nuprin for 72 hours prior to and during the study (occasional use of acetaminophen will be permitted);
- Are using inhaled/systemic/topical corticosteroids in the 3 weeks prior to and during the study, or systemic/topical antihistamines for 72 hours prior to and during the study;
- Are using medication which, in the opinion of the investigative personnel, will interfere with the study results, including anti-inflammatory medications;
- Are unwilling or unable to refrain from the use of sunscreens, cosmetics, creams, ointments, lotions, or similar products on the back during the study;
- Have psoriasis and/or active atopic dermatitis/eczema;
- Are females who are pregnant, plan to become pregnant during the study, or are breast-feeding a child;
- Have a known sensitivity to constituents present in the material being evaluated;
- Have damaged skin in or around the test sites, including sunburn, excessively deep tans, uneven skin tones, tattoos, scars, excessive hair, numerous freckles, or other disfigurations of the test site;
- Have received treatment for any type of internal cancer within 5 years prior to study entry;
- Have a history of, or are currently being treated for skin cancer;
- Are currently participating in any other clinical trial;
- Have any known sensitivity to adhesives; and/or
- Have received any investigational treatment(s) within 4 weeks prior to study entry.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Abametapir Lotion 0.74%
0.2 mL applied topically to the infrascapular area of the back under occlusive patch conditions 3 times weekly for 3 weeks, following with rest period and a challenge.
|
|
PLACEBO_COMPARATOR: Vehicle Lotion
0.2 mL applied topically to the infrascapular area of the back under occlusive patch conditions 3 times weekly for 3 weeks, following with rest period and a challenge.
|
|
OTHER: 0.1% sodium lauryl sulfate
Concurrent control 0.2 mL applied topically to the infrascapular area of the back under occlusive patch conditions 3 times weekly for 3 weeks, following with rest period and a challenge.
|
|
OTHER: Saline 0.9%
Concurrent control 0.2 mL applied topically to the infrascapular area of the back under occlusive patch conditions 3 times weekly for 3 weeks, following with rest period and a challenge.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
to evaluate the sensitizing potential of abametapir lotion using repeat insult patch test design
Time Frame: 8 weeks
|
Evaluation of dermal reactions at the application sites will be assessed clinically using a visual scale that rates the degree of erythema, edema, and other signs of cutaneous irritation
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jonathan Dosik, TKL Research
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2014
Primary Completion (ACTUAL)
March 1, 2014
Study Completion (ACTUAL)
June 1, 2014
Study Registration Dates
First Submitted
February 11, 2014
First Submitted That Met QC Criteria
February 11, 2014
First Posted (ESTIMATE)
February 13, 2014
Study Record Updates
Last Update Posted (ACTUAL)
April 29, 2020
Last Update Submitted That Met QC Criteria
April 27, 2020
Last Verified
April 1, 2020
More Information
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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