Safety and Efficacy of a Head Lice Shampoo

NCT06333054 | Completed

• 1 other identifier: NCLIN0091/ 14ct/mp37li
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

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.

Conditions

Head Lice

Outcome Measures

Primary Outcomes (1)

• Cure Rate superior to 70% for the test product

  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).

  Day 10

Secondary Outcomes (9)

• Cure Rate superior to 70% for the reference product

  Day 10

• Superior cure rate to the reference

  Day 10

• 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

• Global tolerability

  Day 10

Other Outcomes (1)

• Severity of the lice infestation

  Day 0 (before and after treatment),Day 1, Day 7 (before and after treatment), Day 10

Study Arms (2)

Silcap Shampoo

EXPERIMENTAL

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

Device: Silcap Shampoo

Goldgeist® Forte

ACTIVE COMPARATOR

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

Drug: Pyrethrum Extract

Interventions

Pyrethrum Extract DRUG

Treatment with Goldgeist® Forte

Goldgeist® Forte

Silcap Shampoo DEVICE

Treatment with Silcap Shampoo

Also known as: Paranix

Silcap Shampoo

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oystershell NV: lead

Study Sites (1)

CardioSec Clinical Research GmbH

Erfurt, 99084, Germany

Location

Study Officials

• Dörte Wolf, PhD

  CardioSec Clinical Research GmbH

  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: March 19, 2024
• First Posted: March 27, 2024
• Study Start: October 13, 2014
• Primary Completion: June 8, 2015
• Study Completion: June 8, 2015
• Last Updated: March 27, 2024

Record last verified: 2024-03

Locations

DE (1)