Dermal Safety Study to Evaluate the Sensitizing Potential of Abametapir Lotion

NCT ID: NCT02062073

Last Updated: 2020-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 238 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2014-06-30

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.

Conditions

Head Lice

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Abametapir Lotion 0.74% w/w

Intervention Type: DRUG

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.

Group Type: PLACEBO_COMPARATOR

Vehicle Lotion

Intervention Type: 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.

Group Type: OTHER

0.1% sodium lauryl sulfate

Intervention Type: 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.

Group Type: OTHER

saline 0.9%

Intervention Type: OTHER

Interventions

Abametapir Lotion 0.74% w/w

Intervention Type: DRUG

0.1% sodium lauryl sulfate

Intervention Type: OTHER

saline 0.9%

Intervention Type: OTHER

Vehicle Lotion

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

TKL Research, Inc.

INDUSTRY

Sponsor Role: collaborator

Accelovance

INDUSTRY

Sponsor Role: collaborator

Dr. Reddy's Laboratories Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jonathan Dosik

Role: PRINCIPAL_INVESTIGATOR

TKL Research

Locations

TKL Reserach

Paramus, New Jersey, United States

Countries

United States

Other Identifiers

Ha03-006

Identifier Type: -

Identifier Source: org_study_id