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Study Comparing the Safety and Efficacy of 0.5% Ivermectin Cream to Placebo in Lice Infested Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Topaz Pharmaceuticals Inc
ClinicalTrials.gov Identifier:
NCT00994422
First received: October 9, 2009
Last updated: April 4, 2012
Last verified: April 2012
  Purpose

The purpose of this study is to compare the safety and efficacy of a 0.5% ivermectin cream to a placebo in subjects infested with head lice when used in an "at home" environment.


Condition Intervention Phase
Head Lice
Drug: Ivermectin cream
Drug: vehicle control
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind Randomized Study to Compare the Safety, Local Tolerability and Efficacy of a 0.5% Ivermectin Cream Compared to a Topical Vehicle Control in Subjects With Pediculus Humanus Capitis Infestation

Resource links provided by NLM:


Further study details as provided by Topaz Pharmaceuticals Inc:

Primary Outcome Measures:
  • Percentage of Participants With Treatment Success Following Treatment With Either Ivermectin or Placebo (Vehicle Control) [ Time Frame: Days 2 up to Day 15 post-treatment ] [ Designated as safety issue: No ]
    Treatment success was defined as the absence of live lice and was determined by visual examination of hair and scalp by a trained evaluator.

  • Number of Participants Reporting Adverse Events Post-Treatment With Either Ivermectin or Placebo (Vehicle Control) [ Time Frame: Day 1 up to Day 28 post-application ] [ Designated as safety issue: No ]
  • Summary of the Reported Skin/Scalp Irritations Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control) [ Time Frame: Day 1 up to Day 15 post-application ] [ Designated as safety issue: No ]

    Participants skin/scalp irritations were assessed before treatment (Day 1) and Post-treatment with either Ivermectin or placebo by a trained evaluator.

    Severe scalp irritations were defined as follows:

    Severe Pruritus - Nearly constant, frequent scratching, very bothersome; Severe Erythema - Large areas of the scalp are red; Severe Excoriation: Widespread breaking of the skin involving most of the scalp; Severe Pyoderma - Lesions with crusting or other evidence of infection, involving most of the scalp.



Enrollment: 264
Study Start Date: October 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 0.5% ivermectin cream Drug: Ivermectin cream
Up to 4 ounces of topical 0.5% Ivermectin Cream applied to the hair and scalp on day 1.
Placebo Comparator: vehicle control Drug: vehicle control
Up to 4 ounces of vehicle control applied to the hair and scalp on day 1

  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject must have an active head lice infestation defined as: At least 1 live louse (adult and/or nymph) present on the scalp and/or hair, as determined by a trained evaluator (with the exception of the male head of household who may self-assess as being lice free).
  • Subject is male or female.
  • Subject weighs at least 15kg (33 lbs).
  • Subject is in good general health based on medical history.
  • Each subject must have an appropriately signed Informed Consent agreement. A caregiver must sign an Informed Consent agreement for children not old enough to do so. Children of a specified age will be administered a child's assent form.
  • The caregiver of a subject must be willing to allow all household members to be screened for head lice. If other household members are found to have an active head lice infestation, according to the criteria a (above), they must be willing and able to participate in the study. No more than one working male per family may be excluded from evaluation if he is self-assessed as being lice free and cannot come in due to his work schedule. If this individual may have lice, he must come to the test facility; otherwise the entire household will be excluded from study participation.
  • Subject and/or their caregiver must be physically able and willing to apply the test article.
  • Subject agrees not to use any other form of lice treatments (commercial, community-anecdotal, or mechanical/manual) while they are participating in the study.
  • Following application and rinsing of Study Treatment, subject agrees not to shampoo, wash, or rinse their hair or scalp until the 24-hour post-treatment evaluation has been completed.
  • Subject agrees that they will not cut or chemically treat their hair while they are participating in the study.
  • Subject agrees to follow all study instructions.
  • Female subjects of childbearing potential (including a female caregiver even if she is not being treated) must be willing to have a urine pregnancy test.
  • In the event of a subject judged to be incapable of self-treating, the household must have a caregiver willing to apply the treatment at home.

Exclusion Criteria:

  • History of irritation or sensitivity to ivermectin or the cream components, pediculicides or hair care products.
  • Presentation at the treatment site with visible skin/scalp condition(s) that are not attributable to head lice infestation, such as an erythema score that is >2, blisters, vesicles which, in the opinion of the investigative personnel or sponsor, will interfere with safety and/or efficacy evaluations.
  • Presentation at the treatment site with eczema or atopic dermatitis on the skin/scalp.
  • Treatment with a marketed pediculicide (Over the counter [OTC] or Prescription) in the last 7 days.
  • Any condition or illness that, in the opinion of the investigator, may compromise the objective of the protocol.
  • Is receiving any other treatment which, in the opinion of the investigator or study monitor, may interfere with the study results.
  • Females (including caregivers who come in contact with the investigational product) who are pregnant, nursing or planning a pregnancy. (NOTE: female caregivers and all enrolled females of childbearing potential must have a negative urine pregnancy test prior to treatment). If a household has a pregnant female who has an active case of lice, the entire household is excluded from participation. If this pregnant household member does not have an active infestation, this individual must NOT be the caregiver (one who provides treatment to other household members).
  • Is of child-bearing potential and unwilling to use an adequate method of contraception for the duration of the study. Adequate methods of contraception include: abstinence, vasectomized partner, oral birth control pills, birth control injections or patches, Intra Uterine Devices, condoms with a spermicidal jelly or a diaphragm with spermicidal jelly, surgical sterilization.
  • Participation in a previous investigational drug study within the past 30 days.
  • Does not understand the requirements for study participation and/or may likely exhibit poor compliance, in the opinion of the investigator.
  • Does not have a known household affiliation with their household members (i.e., do not stay in one household consistently, sleeping at one place several nights and then at another place or location). Household is defined as living in a shared area or space (for example the same house or apartment unit).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00994422

Locations
United States, Arizona
Cactus Kids Pediatrics
Yuma, Arizona, United States, 85364
United States, California
Impact Clinical Trials
Los Angeles, California, United States, 90057
United States, Florida
Lice Cleanique, LLC
Delray Beach, Florida, United States, 33484
Hill-Top Research Corp
St Petersburg, Florida, United States, 33710
LSRN
West Palm Beach, Florida, United States, 33407
United States, Minnesota
Minnesota Clinical Study Center
Fridley, Minnesota, United States, 55432
United States, New Mexico
Lovelace Scientific Resources, Inc.
Albuquerque, New Mexico, United States, 87108
United States, North Carolina
Haywood Pediatric Adolescent Medicine Group, PA
Clyde, North Carolina, United States, 28721
United States, Ohio
Hill Top Research Corp.
Miamiville, Ohio, United States, 45147
United States, Tennessee
LSRN
Nashville, Tennessee, United States, 37206
United States, Texas
Northeast Houston Pediatric Clinic
Houston, Texas, United States, 77015
United States, Virginia
Virgina Clinical Research, Inc.
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
Topaz Pharmaceuticals Inc
Investigators
Study Director: Medical Director Sanofi Topaz
  More Information

No publications provided

Responsible Party: Topaz Pharmaceuticals Inc
ClinicalTrials.gov Identifier: NCT00994422     History of Changes
Other Study ID Numbers: TOP010
Study First Received: October 9, 2009
Results First Received: March 7, 2012
Last Updated: April 4, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Topaz Pharmaceuticals Inc:
PEDICULUS HUMANUS CAPITIS
Head Lice

Additional relevant MeSH terms:
Ivermectin
Anti-Infective Agents
Antiparasitic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014