Safety and Efficacy of a Head Lice Shampoo (NCT06333054) | Clinical Trial Compass
CompletedNot Applicable
Safety and Efficacy of a Head Lice Shampoo
Germany109 participantsStarted 2014-10-13
Plain-language 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.
Who can participate
Age range1 Year
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 feedin…