Head Lice
Conditions
Keywords
Hatchtech
Brief summary
The purpose of the study is to determine the irritation potential of repeat applications of abametapir lotion on normal skin.
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.
Interventions
applied 0.2 mL topically under occlusive condition
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.
DRUGSaline 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
DRUGPlacebo
Sponsors
Dr. Reddy's Laboratories Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Randomized Subjects 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. | 40 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 2 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | All Randomized Subjects |
|---|---|
| Age, Customized | 46.95 years STANDARD_DEVIATION 14.98 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 14 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 26 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Fitzpatrick Skin Type Fitzpatrick Type 1 | 1 Participants |
| Fitzpatrick Skin Type Fitzpatrick Type 2 | 15 Participants |
| Fitzpatrick Skin Type Fitzpatrick Type 3 | 11 Participants |
| Fitzpatrick Skin Type Fitzpatrick Type 4 | 12 Participants |
| Fitzpatrick Skin Type Fitzpatrick Type 5 | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 37 Participants |
| Region of Enrollment United States | 40 participants |
| Sex: Female, Male Female | 28 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 40 |
| other Total, other adverse events | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 |
Outcome results
Primary
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.
Time frame: 21 days
Population: All Randomized Subjects
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Abametapir Lotion Group | Potential of Abametapir Lotion to Cause Irritation After Repeated Topical Application to the Healthy Skin of Humans. | 1.10 score on a scale | Standard Deviation 3.11 |
| Vehicle Lotion | Potential of Abametapir Lotion to Cause Irritation After Repeated Topical Application to the Healthy Skin of Humans. | 0.70 score on a scale | Standard Deviation 2.89 |
| Saline 0.9% | Potential of Abametapir Lotion to Cause Irritation After Repeated Topical Application to the Healthy Skin of Humans. | 1.10 score on a scale | Standard Deviation 6.48 |
| Sodium Lauryl Sulphate (SLS) | Potential of Abametapir Lotion to Cause Irritation After Repeated Topical Application to the Healthy Skin of Humans. | 49.15 score on a scale | Standard Deviation 8.87 |