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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Elimax Green Lotion with Emogreen
DeviceSTEP 1: Apply the lotion to dry hair, completely saturating hair and scalp. Use a towel to cover eyes and exposed skin areas. Massage from the roots to the tips, paying particular attention to the area behind the ears and the hairline at the back of the head. Leave the lotion in the hair for 10 minutes (no longer). In the case of long hair, pin the hair up away from the skin after application. STEP 2: Wash out by applying shampoo to the hair and rinsing thoroughly. Repeat if needed to fully rinse out the lotion. STEP 3: Comb to remove lice and nits. Part the hair into sections and comb one section at a time. Place the teeth of the comb as close as possible to the scalp and comb away from the scalp to the end of the hair. Use clips to pin back each section of combed hair. Clean the comb during use by wiping onto a tissue. Discard the tissue into a sealable bag. Discard the sealed bag. Check hair for the following 7 to 10 days. If lice or nits are present, repeat steps 1-3.
Walgreens Lice Killing Shampoo
DrugApply thoroughly to dry hair or other affected area. For head lice, first apply behind ears and to back of neck Allow product to remain for 10 minutes, but no longer Use warm water to form a lather, shampoo, then thoroughly rinse For head lice, towel dry hair and comb out tangles Remove lice and their eggs (nits) Use a fine-tooth or special lice/nit comb. Remove any remaining nits by hand (using a throw-away glove) Hair should remain slightly damp while removing nits If hair dries during combing, dampen slightly with water For head lice, part hair into sections. Do one section at a time starting at the top of the head. Longer hair may take 1 to 2 hours. Lift a 1- to 2- inch wide strand of the hair. Place comb as close as possible to the scalp and comb with a firm, even motion away from the scalp. Pin back each strand of the hair after combing Clean comb often. Wipe away nits with tissue and discard in a plastic bag. Seal bag and discard bag to prevent lice from coming back.
Treatment groups
86 Participants
are divided into 2 treatment groupsGroup A: Treatment with Elimax Green Lotion with EmogreenExperimental treatment 1 intervention
Group B: Treatment with Walgreens Lice Killing ShampooActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Cure rate
Demonstrate that local application of Elimax Green Lotion with Emogreen achieves a cure rate that is non-inferior to Wallgreens Lice Killings Shampoo, at the end of day 10, corrected for re-infestation. A non-inferiority margin of 3% will be applied. If non-inferiority is established, a subsequent test will be conducted to assess whether the test product is superior to the reference product. This implies that the lower bound of the confidence interval for the difference in cure rates lies above zero.
Time frame
From enrolment to the end of treatment on day 10Secondary outcomes
1
Efficacy for mild and moderate baseline infestations
Determine efficacy of the investigational product for head lice for mild and moderate baseline infestations (cure rate at the end of the study day 10, uncorrected as well as corrected for re-infestation).
Time frame
From enrolment to the end of treatment on day 102
Efficacy of the investigational product for all baseline infestations
Determine efficacy of the investigational product for all baseline infestations (cure rate at day 1).
Time frame
From enrolment to the end of treatment on day 13
Efficacy of the investigational product for mild and moderate baseline infestations.
Determine efficacy of the investigational product for mild and moderate baseline infestations (cure rate at day 1).
Time frame
From enrolment to the end of treatment on day 14
Local tolerability
To evaluate local tolerability by subject: subjective symptoms (burning, paraesthesia, pruritus): 0h, 1h, 24h, 7d and 10d p.a. (descriptive evaluation). The following 4-category scale will be used: * Score 1 - None: No sensation reported. * Score 2 - Mild: Slight, brief sensation (e.g. tingling or slight itch) easily tolerated and does not interfere with daily activities. * Score 3 - Moderate: Apparent discomfort (e.g. burning sensation, moderate itching) that may periodically distract or cause a minor disruption but does not require any treatment. * Score 4 - Severe: Prolonged or intense sensation (e.g. strong burning and/or itching) that interferes with normal activities or requires an intervention (e.g. cold compress, medication).
Time frame
From enrolment to the end of treatment on day 10Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Oystershell NV
Lead sponsor
Lice Solutions Resource Network (LSRN) Research
Collaborator
Source ClinicalTrials.gov