Safety and Efficacy of Head-lice Treatments Elimax Green Lotion and Walgreens Lice Killing Shampoo
ConditionHead Lice
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6+
SponsorOystershell NV
About this trial
Compare efficacy and safety of Elimax Green Lotion Emogreen (RID SUper Max Solution) to that of Walgreens Lice Killing Shampoo against headlice in infested individuals. Involved subjects aged 6 months and older, of both genders, with a confirmed diagnosis of head lice infestation are included. Local and global tolerability, skin and eye irritation are monitored throughout the study. Any adverse events will be monitored and recorded.
Eligibility criteria
Qualifiers
Gender: male / female.
Female subjects with childbearing potential who test negative for pregnancy and agree to use a reliable method of birth control (as described in section7.8) or remain
Age ≥ 6 months of age at the time of enrollment.
Subject must have an active head lice infestation defined as at least 5 live lice (adults and/or nymphs) and 5 live nits based on magnified observations, present on the scalp and/or hair, as determined by a trained evaluator.
Disqualifiers
Application of any form of head lice treatment, whether prescription or over-thecounter (OTC), or home remedy for 14 days prior to their screening visit (Visit
Application of any topical medication of any kind on the hair or scalp for a period of 48 hours prior to the screening visit.
Use of systemic or topical drugs or medications, including systemic antibiotics, which in the opinion of the investigative personnel may interfere with the study results.
Known skin allergies, multiple drug allergies or multiple allergies to cosmetic products.
Trial design
Treatments tested in this trial
- Elimax Green Lotion with Emogreen
- Walgreens Lice Killing Shampoo
Treatment groups
86 Participants
are divided into 2 treatment groupsSponsors and collaborators
Oystershell NV
Lead sponsor
Lice Solutions Resource Network (LSRN) Research
Collaborator
Source ClinicalTrials.gov