Dermal Safety Study to Evaluate Potential Irritation of Abametapir Lotion

• Sponsor: Dr. Reddy's Laboratories Limited (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02061813
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 4
• Duration (Months): 3.9
• Patients Per Site Per Month: 10.1

Study Details

Study Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 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: Jan 1, 2014
• Actual Primary Completion Date: Jan 1, 2014
• Actual Study Completion Date: May 1, 2014

Arms and Interventions

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
Other: 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.
Other: 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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	TKL Reserach Inc	Paramus	New Jersey	United States	07652

Sponsors and Collaborators

• Dr. Reddy's Laboratories Limited

Investigators

• Principal Investigator: Jonathan Dosik, TKL Research, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr. Reddy's Laboratories Limited
• ClinicalTrials.gov Identifier: NCT02061813
• Other Study ID Numbers: Ha03-007
• First Posted: Feb 13, 2014
• Last Update Posted: Jul 26, 2021
• Last Verified: Jul 1, 2021

• Keywords provided by Dr. Reddy's Laboratories Limited: Hatchtech

Study Results

Participant Flow

Arm/Group Title	All Randomized Subjects
Arm/Group Description	All Randomized Subjects included all subjects who were enrolled into the study. All subjects had 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.
Period Title: Overall Study
STARTED	40
Abametapir Lotion	40
Vehicle Lotion	40
Saline 0.9%	40
SLS 0.2%	40
COMPLETED	37
NOT COMPLETED	3

Baseline Characteristics

Arm/Group Title	All Randomized Subjects
Arm/Group Description	All Randomized Subjects included all subjects who were enrolled into the study. All subjects had 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.
Overall Participants	40
Age, Customized (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	46.95 (14.98)
Sex: Female, Male (Count of Participants)
Female	28 70%
Male	12 30%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	14 35%
Not Hispanic or Latino	26 65%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	2 5%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	1 2.5%
White	37 92.5%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	40 100%
Fitzpatrick Skin Type (Count of Participants)
Fitzpatrick Type 1	1 2.5%
Fitzpatrick Type 2	15 37.5%
Fitzpatrick Type 3	11 27.5%
Fitzpatrick Type 4	12 30%
Fitzpatrick Type 5	1 2.5%

Outcome Measures

1. Primary Outcome

Title	Potential of Abametapir Lotion to Cause Irritation After Repeated Topical Application to the Healthy Skin of Humans.
Description	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.
Time Frame	21 days

Outcome Measure Data

Analysis Population Description

All Randomized Subjects

Arm/Group Title	Abametapir Lotion Group	Vehicle Lotion	Saline 0.9%	Sodium Lauryl Sulphate (SLS)
Arm/Group Description	All Subjects in the study received all treatments simultaneously on a daily basis, as it was an intra-subject comparison design	All Subjects in the study received all treatments simultaneously on a daily basis, as it was an intra-subject comparison design	All Subjects in the study received all treatments simultaneously on a daily basis, as it was an intra-subject comparison design	All Subjects in the study received all treatments simultaneously on a daily basis, as it was an intra-subject comparison design
Measure Participants	40	40	40	40
Measure Skin Sites	40	40	40	40
Mean (Standard Deviation) [score on a scale]	1.10 (3.11)	0.70 (2.89)	1.10 (6.48)	49.15 (8.87)

Adverse Events

Time Frame	All Adverse events were systematically recorded from the time of signing informed consent until the last assessment i.e. 21 days.
Arm/Group Title	All Randomized Subjects
Arm/Group Description	All Randomized Subjects included all subjects who were enrolled into the study. All subjects received application of all four interventions.
All Cause Mortality
	All Randomized Subjects
	Affected / at Risk (%)	# Events
Total	0/40 (0%)
Serious Adverse Events
	All Randomized Subjects
	Affected / at Risk (%)	# Events
Total	0/40 (0%)
Other (Not Including Serious) Adverse Events
	All Randomized Subjects
	Affected / at Risk (%)	# Events
Total	0/40 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.