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Trial record 15 of 49 for:    Sodium Lauryl Sulfate

Dermal Safety Study to Evaluate the Sensitizing Potential of Abametapir Lotion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02062073
Recruitment Status : Completed
First Posted : February 13, 2014
Last Update Posted : March 16, 2016
Sponsor:
Collaborators:
TKL Research, Inc.
Accelovance
Information provided by (Responsible Party):
Hatchtech Pty Ltd

Tracking Information
First Submitted Date  ICMJE February 11, 2014
First Posted Date  ICMJE February 13, 2014
Last Update Posted Date March 16, 2016
Study Start Date  ICMJE January 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 11, 2014)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02062073 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dermal Safety Study to Evaluate the Sensitizing Potential of Abametapir Lotion
Official Title  ICMJE A Randomized, Controlled Study to Evaluate the Sensitizing Potential of Abametapir Lotion in Healthy Volunteers Using a Repeat Insult Patch Test Design
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Head Lice
Intervention  ICMJE
  • Drug: Abametapir Lotion 0.74% w/w
  • Other: 0.1% sodium lauryl sulfate
  • Other: saline 0.9%
  • Other: Vehicle Lotion
Study Arms  ICMJE
  • 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.
    Intervention: 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.
    Intervention: 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.
    Intervention: 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.
    Intervention: Other: saline 0.9%
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 11, 2014)
238
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02062073
Other Study ID Numbers  ICMJE Ha03-006
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hatchtech Pty Ltd
Study Sponsor  ICMJE Hatchtech Pty Ltd
Collaborators  ICMJE
  • TKL Research, Inc.
  • Accelovance
Investigators  ICMJE Not Provided
PRS Account Hatchtech Pty Ltd
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP