Clinical trial NCT06333054: Safety and Efficacy of a Head Lice Shampoo
Official title: A Randomised, Controlled, Investigator Blinded, Comparative Study to Evaluate the Safety and Efficacy of a Head Lice Shampoo.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head Lice
Lead sponsor: Oystershell NV
Sponsor class: INDUSTRY
First posted: 2024-03-27
Enrollment: 109
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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
* The patients are investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
* The patients are Oystershell employees or are employees of third-party organizations involved in the study.

Primary outcomes:
measure: Cure Rate superior to 70% for the test product
timeFrame: Day 10
Secondary outcomes:
measure: Cure Rate superior to 70% for the reference product
timeFrame: Day 10
measure: Superior cure rate to the reference
timeFrame: Day 10
measure: Non-inferiority rate to the reference
timeFrame: Day 10
measure: Local tolerability
timeFrame: Day 0 (at start and after treatment), Day 1, Day 7 (at start and after treatment), Day 10
measure: Global tolerability
timeFrame: Day 10
measure: Skin irritation assessment
timeFrame: Day 0 (before, at start and after treatment),Day 1, Day 7 (before, at start and after treatment), Day 10
measure: Eye irritation assessment
timeFrame: Day 0 (before, at start and after treatment),Day 1, Day 7 (before, at start and after treatment), Day 10
measure: Esthetical effect of the anti-lice products
timeFrame: Day 0 (after treatment); day 7 (after treatment)
measure: Adverse Events (AEs)
timeFrame: Day 0 (at start and after treatment),Day 1, Day 7 (at start and after treatment), Day 10
Other outcomes:
measure: Severity of the lice infestation
timeFrame: Day 0 (before and after treatment),Day 1, Day 7 (before and after treatment), Day 10
Locations:
city: Erfurt
country: Germany
facility: CardioSec Clinical Research GmbH
Study officials:
affiliation: CardioSec Clinical Research GmbH
name: Dörte Wolf, PhD
role: PRINCIPAL_INVESTIGATOR
References: