Dermal Safety Study to Evaluate Potential Irritation of Abametapir Lotion

NCT02061813 | Completed Phase 1 Results

• 1 other identifier: Ha03-007
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Head Lice

Keywords

Hatchtech

Outcome Measures

Primary Outcomes (1)

• Potential of Abametapir Lotion to Cause Irritation After Repeated Topical Application to the Healthy Skin of Humans.

  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 numerical equivalents (0-7) where 0 is the least irritation potential and 7 is the maximum irritation potential. The scoring will be done on daily basis from baseline through Day 21 visit. The final reported outcome is a mean of the scores over 21 days.

  21 days

Study Arms (4)

Abametapir lotion 0.74% w/w

EXPERIMENTAL

Applied 0.2 mL topically under occlusive condition

Drug: Abametapir Lotion 0.74% w/w

Vehicle lotion

PLACEBO COMPARATOR

Applied 0.2 mL topically under occlusive condition

Drug: Placebo

Sodium Lauryl Sulfate

OTHER

Positive control applied 0.2 mL topically under occlusive condition

Drug: Sodium Lauryl Sulfate

Saline 0.9%

OTHER

Negative control applied 0.2 mL topically under occlusive condition

Drug: Saline 0.9%

Interventions

Abametapir Lotion 0.74% w/w DRUG

applied 0.2 mL topically under occlusive condition

Abametapir lotion 0.74% w/w

Sodium Lauryl Sulfate DRUG

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.

Sodium Lauryl Sulfate

Saline 0.9% DRUG

A solution of 0.9% saline for topical administration, applied 21 times over consecutive days under occlusive conditions, will serve as a negative control

Saline 0.9%

Placebo DRUG

Vehicle lotion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 (UPT) at Day 1, and are willing to submit to a pregnancy test at the end of study (EOS);
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead

Study Sites (1)

TKL Reserach Inc

Paramus, New Jersey, 07652, United States

Location

MeSH Terms

Interventions

Sodium Dodecyl Sulfate; Sodium Chloride

Intervention Hierarchy (Ancestors)

Dodecanol; Fatty Alcohols; Alcohols; Organic Chemicals; Alkanesulfonates; Alkanesulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Lipids; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Dr Srinivas Sidgiddi
• Organization: Dr. Reddy's Laboratories Inc.

srinivassidgiddi@drreddys.com

9084585362

Study Officials

• Jonathan Dosik

  TKL Research, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2014
• First Posted: February 13, 2014
• Study Start: January 1, 2014
• Primary Completion: January 1, 2014
• Study Completion: May 1, 2014
• Last Updated: July 26, 2021
• Results First Posted: July 26, 2021

Record last verified: 2021-07

Locations

US (1)