A Randomised, Controlled, Investigator Blinded, Comparative Study to Evaluate the Safety and Efficacy of a Head Lice Shampoo.

Oystershell NV1 site in 1 country109 target enrollmentOctober 13, 2014

ConditionsHead Lice

InterventionsSilcap Shampoo Pyrethrum Extract

DrugsPyrethrum Extract

Overview

Phase: N/A
Intervention: Silcap Shampoo
Conditions: Head Lice
Sponsor: Oystershell NV
Enrollment: 109
Locations: 1
Primary Endpoint: Cure Rate superior to 70% for the test product
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study is designed to compare the effectiveness and safety of test head lice shampoo (Test product) versus Goldgeist® Forte (reference product) following two applications.

Detailed Description

The primary objective was to show, that the cure rate after local application of Test head lice shampoo is better than a predefined limit. It had to be shown, that the Test head lice shampoo achieved a cure rate superior to 70% (cure rate at the end of day 10, corrected for re-infestation).

Registry

clinicaltrials.gov

Start Date

October 13, 2014

End Date

June 8, 2015

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Oystershell NV

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Gender: male/female
•Age: ≥ 1 year of age at the time of signing the informed consent
•Patients with active head lice infestation of at least 5 living lice and 5 apparently living eggs
•Patient or his/her guardian must be capable of understanding and providing written informed consent
•The patient or his/her legal representative must give written informed consent, after having been oral and written informed about benefits and potential risks of the trial, as well as details of the insurance taken out to cover the subjects participating in the study
•Patients must agree to not use any other ant-lice treatment for the duration of the study
•Female patients:
•are women of childbearing potential who test negative for pregnancy and agree to use a reliable method of birth control or remain abstinent duringthe study. Methods of contraception considered acceptable include oral contraceptives, contraceptive patch, intrauterine device, vaginal ring, diaphragm with contraceptive gel, or condom with contraceptive gel
•or are women of non-childbearing potential, defined as: women who have had surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation),
•or women who are ≥ 60 years of age.

Exclusion Criteria

•Known allergic reactions or hypersensitivity to the active ingredients used or the constituents
•Patients with known skin allergies, multiple drug allergies or multiple allergies to cosmetic products
•Pregnant or breast feeding women
•Patient underwent treatment with any form of head lice treatment within the last 30 days prior to the Screening Visit (day 0)
•Patients with chronic scalp disorder
•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
•Subjects with hair longer than mid-back
•Patients suspected or known not to follow instructions
•Patients or his/her legal representative who are unable to understand the written and verbal instructions, in particular regarding the risks and inconveniences they will be exposed to as a result of their participation in the study
•Previous participation in this study or participation in any other investigational trial within the preceding 30 days

Arms & Interventions

Silcap Shampoo

Subjects with head lice were treated with Silcap Shampoo at visit 1 (day 0) and at visit 3 (day 7).

Intervention: Silcap Shampoo

Goldgeist® Forte

Subjects with head lice were treated with Goldgeist® Forte at visit 1 (day 0) and at visit 3 (day 7).

Intervention: Pyrethrum Extract

Outcomes

Primary Outcomes

Cure Rate superior to 70% for the test product

Time Frame: Day 10

Secondary Outcomes

Non-inferiority rate to the reference(Day 10)
Local tolerability(Day 0 (at start and after treatment), Day 1, Day 7 (at start and after treatment), Day 10)
Adverse Events (AEs)(Day 0 (at start and after treatment),Day 1, Day 7 (at start and after treatment), Day 10)
Cure Rate superior to 70% for the reference product(Day 10)
Skin irritation assessment(Day 0 (before, at start and after treatment),Day 1, Day 7 (before, at start and after treatment), Day 10)
Esthetical effect of the anti-lice products(Day 0 (after treatment); day 7 (after treatment))
Superior cure rate to the reference(Day 10)
Global tolerability(Day 10)
Eye irritation assessment(Day 0 (before, at start and after treatment),Day 1, Day 7 (before, at start and after treatment), Day 10)