NCT01803581

Brief Summary

The purpose of this study is to compare the efficacy and safety of an insecticide-free head lice product with that of a pyrethrum-based product.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2013

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 4, 2013

Completed
1 day until next milestone

Study Start

First participant enrolled

March 5, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 12, 2013

Completed
Last Updated

April 5, 2018

Status Verified

November 1, 2013

Enrollment Period

4 months

First QC Date

February 12, 2013

Last Update Submit

April 3, 2018

Conditions

Head Lice

Outcome Measures

Primary Outcomes (1)

  • The proportion of subjects lice free at the end of the study (Day 10)

    Primary objective of this study was the cure rate (%) in each treatment group, following two applications (day 0 and day 7) of the specific test product, as assessed on the last evaluation visit (day 10).

    Day 10

Secondary Outcomes (1)

  • The proportion of subjects lice free at each of the intermediate evaluations (Day 1, Day 7)

    Day 1, Day 7

Other Outcomes (3)

  • Eye irritation

    Day0, Day 1, Day7, Day10

  • Scalp condition

    Day0, Day1, Day7, Day10

  • Adverse events collection

    Day 0, Day1, Day7, Day10

Study Arms (2)

X92001327

EXPERIMENTAL

the X92001327 product is a lotion to be applied on dry hair for 15 minutes and then washed out using shampoo. The product is to be applied on Day 0 and repeated again on Day 7.

Other: X92001327

RID shampoo

ACTIVE COMPARATOR

The RID shampoo is to be applied on dry the hair for 10 minutes and then rinsed out with water. the product is to be applied on Day 0 and repeated again on Day 7.

Other: RID shampoo

Interventions

X92001327OTHER
X92001327
RID shampooOTHER
RID shampoo

Eligibility Criteria

Age1 Year+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female over the age of 1 at the time of signing the informed consent or giving assent
  • Have an active head lice infestation of at least 5 live lice and 5 viable nits
  • subject must be capable of understanding and providing written informed consent
  • agree not to use any other pediculicides or medicated hair grooming products for the duration of the study
  • agree not to use a lice comb during the study
  • the parent or guardian of a child must be willing to have other family members screened for head lice.
  • have a single place of residence

You may not qualify if:

  • used any form of head lice treatment whether prescription or over the counter or home remedy at least four weeks prior to their screening visit
  • used any topical medication of any kind for a period of 48 hours prior to the screening visit
  • individuals on systemic or topical drugs or medications, including systemic antibiotics, which in the opinion of the investigative personnel may interfere with the study results
  • has a history of allergy or hypersensitivity to ragweed, hydrocarbons, sesame oil, perfume or any ingredient in either test product
  • individuals with any visible skin/scalp condition at the treatment site which, in the opinion of the investigative personnel will interfere with the evaluation of the test product
  • individuals who, in the opinion of the investigative personnel do not understand the subject requirements for study participation and/or may be likely to exhibit poor compliance with the required visits
  • females who are pregnant or nursing
  • patients that have taken trimethoprim or a combination of sulfamethoxazole at evaluation or during the previous 4 weeks
  • subjects with hair longer than mid back

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lice Source services Inc

Plantation, Florida, 33313, United States

Location

Related Publications (1)

  • Barker SC, Burgess I, Meinking TL, Mumcuoglu KY. International guidelines for clinical trials with pediculicides. Int J Dermatol. 2012 Jul;51(7):853-8. doi: 10.1111/j.1365-4632.2011.05446.x.

    PMID: 22715834BACKGROUND

Study Officials

  • Lidia Serrano

    Lice Source Services

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2013

First Posted

March 4, 2013

Study Start

March 5, 2013

Primary Completion

June 20, 2013

Study Completion

August 12, 2013

Last Updated

April 5, 2018

Record last verified: 2013-11

Locations

US(1)