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Dermal Safety Study to Evaluate Potential Irritation of Abametapir Lotion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02061813
Recruitment Status : Completed
First Posted : February 13, 2014
Last Update Posted : July 1, 2014
Information provided by (Responsible Party):
Hatchtech Pty Ltd

Brief Summary:
The purpose of the study is to determine the irritation potential of repeat applications of abametapir lotion on normal skin.

Condition or disease Intervention/treatment Phase
Head Lice Drug: Abametapir Lotion 0.74% w/w Drug: Sodium Lauryl Sulfate Drug: Saline 0.9% Drug: Placebo Phase 1

Detailed Description:

This will be a randomized, evaluator-blind, single-center, controlled, within-subject comparison study of the investigational products (abametapir lotion) and its vehicle lotion and positive and negative controls under occlusive conditions in healthy volunteers. All subjects will have the investigational product (abametapir lotion), the vehicle product, the positive control patch, and negative control patch applied to 4 randomly assigned, adjacent skin sites on the infrascapular area of their back, for the purpose of determining irritation potential.

The investigational products, vehicle, and controls will be applied to one side of the infrascapular area of the back. 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 (see Section 3.5.5).

A total of 21 applications of each product will be made.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A 21-Day, Randomized, Controlled Study to Evaluate the Irritation Potential of Abametapir Lotion in Healthy Volunteers, Using a Cumulative Irritant Patch Test Design
Study Start Date : January 2014
Actual Primary Completion Date : January 2014
Actual Study Completion Date : May 2014

Arm Intervention/treatment
Experimental: Abametapir lotion 0.74% w/w
Applied 0.2 mL topically under occlusive condition
Drug: Abametapir Lotion 0.74% w/w
applied 0.2 mL topically under occlusive condition

Placebo Comparator: Vehicle lotion
Applied 0.2 mL topically under occlusive condition
Drug: Placebo
Sodium Lauryl Sulfate
Positive control applied 0.2 mL topically under occlusive condition
Drug: Sodium Lauryl Sulfate
Sodium Lauryl Sulfate is prepared as a 0.2% aqueous solution by the site for topical administration, and applied 21 times over consecutive days under occlusive conditions, will serve as a positive control.

Saline 0.9%
Negative control applied 0.2 mL topically under occlusive condition
Drug: Saline 0.9%
A solution of 0.9% saline for topical administration, applied 21 times over consecutive days under occlusive conditions, will serve as a negative control

Primary Outcome Measures :
  1. Evaluate the potential of abametapir lotion to cause irritation after repeated topical application to the healthy skin of humans under controlled conditions. [ Time Frame: 21 days ]
    The evaluation of irritation is based on Modified Berger procedure and is accepted as standard methodology for assessment of cumulative irritation potential. The assessment of all patch sites for irritation symptoms will be visually assessed by a trained evaluator using the response symbols and numerical equivalents (0-7) and effects on superficial layers of the skin symbols (A-H) will be done at daily basis from baseline through Day 21 visit.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Are healthy (to be confirmed by medical history) males or females, 18 years of age or older;
  2. 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;
  3. If female of childbearing potential, have a negative urine pregnancy test (UPT) at Day 1, and are willing to submit to a pregnancy test at the end of study (EOS);
  4. 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;
  5. Are of any skin type or race, providing the skin pigmentation will allow discernment of erythema;
  6. Complete a patch study Medical Screening form as well as a Medical Personal History form; and
  7. Read, understand, and provide signed informed consent.

Exclusion Criteria:

  1. 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;
  2. 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);
  3. 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;
  4. Are using medication which, in the opinion of the investigative personnel, will interfere with the study results, including anti-inflammatory medications;
  5. Are unwilling or unable to refrain from the use of sunscreens, cosmetics, creams, ointments, lotions, or similar products on the back during the study;
  6. Have psoriasis and/or active atopic dermatitis/eczema;
  7. Are females who are pregnant, plan to become pregnant during the study, or are breast-feeding a child;
  8. Have a known sensitivity to constituents present in the material being evaluated;
  9. 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
  10. Have received treatment for any type of internal cancer within 5 years prior to study entry;
  11. Have a history of, or are currently being treated for skin cancer;
  12. Are currently participating in any other clinical trial,
  13. Have any known sensitivity to adhesives; and/or
  14. Have received any investigational treatment(s) within 4 weeks prior to study entry.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02061813

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United States, New Jersey
TKL Reserach Inc
Paramus, New Jersey, United States, 07652
Sponsors and Collaborators
Hatchtech Pty Ltd
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Principal Investigator: Jonathan Dosik TKL Research, Inc.

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Responsible Party: Hatchtech Pty Ltd Identifier: NCT02061813     History of Changes
Other Study ID Numbers: Ha03-007
First Posted: February 13, 2014    Key Record Dates
Last Update Posted: July 1, 2014
Last Verified: June 2014

Keywords provided by Hatchtech Pty Ltd: