Dermal Safety Study to Evaluate the Sensitizing Potential of Abametapir Lotion

• Sponsor: Hatchtech Pty Ltd
• Collaborators: TKL Research, Inc.; Accelovance
• Information provided by (Responsible Party): Hatchtech Pty Ltd

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Head Lice	Drug: Abametapir Lotion 0.74% w/w; Other: 0.1% sodium lauryl sulfate; Other: saline 0.9%; Other: Vehicle Lotion	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 238 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomized, Controlled Study to Evaluate the Sensitizing Potential of Abametapir Lotion in Healthy Volunteers Using a Repeat Insult Patch Test Design
• Study Start Date: January 2014
• Actual Primary Completion Date: March 2014
• Actual Study Completion Date: June 2014

Arms and Interventions

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.	Drug: Abametapir Lotion 0.74% w/w
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: Vehicle Lotion
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: 0.1% sodium lauryl sulfate
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.	Other: saline 0.9%

Outcome Measures

Primary Outcome Measures :

1. 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

Eligibility Criteria

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

Criteria

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 at Day 1, and are willing to submit to a pregnancy test at the end of study;
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.

Contacts and Locations

Locations

United States, New Jersey

TKL Reserach

Paramus, New Jersey, United States, 07652

Sponsors and Collaborators

Hatchtech Pty Ltd

TKL Research, Inc.

Accelovance

More Information

• Responsible Party: Hatchtech Pty Ltd
• ClinicalTrials.gov Identifier: NCT02062073 History of Changes
• Other Study ID Numbers: Ha03-006
• First Posted: February 13, 2014
• Last Update Posted: March 16, 2016
• Last Verified: March 2016

Keywords provided by Hatchtech Pty Ltd:

head lice; Hatchtech