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Comparaison des traitements contre les poux de tête : Lotion verte Elimax vs Shampooing contre les poux de Walgreens

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Ce qui est testé

Elimax Green Lotion with Emogreen

+ Walgreens Lice Killing Shampoo
Dispositif médical
Médicament
Qui peut participer

À partir de 6 mois
Voir tous les critères d'éligibilité
Comment se déroule l'étude

Étude thérapeutique

Interventionnel
Date de début : octobre 2025
Voir le détail du protocole

Résumé

Sponsor principalOystershell NV
Dernière mise à jour : 11 décembre 2025
Issu d'une base de données validée par les autorités. Revendiquer cette étude
Date de début de l'étude : 2 octobre 2025Date à laquelle le premier participant a commencé l'étude.

Cette étude se concentre sur la comparaison de deux traitements contre les infestations de poux de tête : la lotion verte Elimax Green avec Emogreen et le shampoing tueur de poux de Walgreens. Les poux de tête sont un problème courant qui affecte les personnes de tous âges, en particulier les enfants. L'étude vise à déterminer quel produit est plus efficace et plus sûr pour traiter les poux de tête. La lotion verte Elimax Green agit en asphyxiant et en déshydratant physiquement les poux et leurs œufs grâce à ses ingrédients, qui comprennent un bio-alcane et de la cire d'abeille. Cette recherche est importante car elle pourrait fournir une solution plus efficace pour les personnes souffrant de poux de tête, améliorant le confort et réduisant le temps passé à traiter les infestations. Les participants à cette étude doivent avoir six mois ou plus et avoir un cas confirmé de poux de tête. L'étude suivra les directives pour les essais cliniques de dispositifs médicaux conformément aux réglementations américaines. Les participants utiliseront le produit selon les instructions, impliquant généralement l'application du traitement et l'utilisation d'un peigne à poux. Les chercheurs surveilleront la sécurité en vérifiant tout signe d'irritation cutanée ou oculaire et d'autres événements indésirables. L'objectif est de s'assurer que le produit fonctionne efficacement et est également sûr pour les utilisateurs. En comparant les résultats de ces deux traitements, l'étude vise à offrir de meilleures orientations pour les personnes confrontées aux poux de tête.

Titre officielIn Vivo Testing: A Two-Arm, Randomized, Controlled, Investigator/Assessor-Blinded, Comparative Study to Evaluate the Safety and Efficacy of a Head Lice Physically Acting Product: ELIMAX GREEN LOTION EMOGREEN (X92001752) vs Walgreens Lice Killing Shampoo (Piperonyl Butoxide (4%),Pyrethrum Extract (Equivalent to 0.33% Pyrethrins)) in Subjects With Head Lice. 
NCT07191457
Sponsor principalOystershell NV
Dernière mise à jour : 11 décembre 2025
Issu d'une base de données validée par les autorités. Revendiquer cette étude

Protocole

Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.
Détails du design
86 participants à inclureNombre total de participants que l'essai clinique vise à recruter.
Traitement
Cette étude teste un ou plusieurs traitements pour évaluer leur efficacité contre une maladie ou un problème de santé spécifique. L'objectif est de voir si un nouveau médicament ou une thérapie fonctionne mieux, ou provoque moins d'effets secondaires que les options existantes.

Comment les participants sont répartis entre les groupes de l'étude
Dans cette étude clinique, les participants sont répartis de manière aléatoire, comme lors d'un tirage au sort. Cela garantit l'équité et réduit les biais, rendant les résultats plus fiables. En attribuant les participants au hasard, les chercheurs peuvent comparer les traitements sans influence extérieure.

Autres méthodes de répartition
Répartition non aléatoire
: basée sur des critères spécifiques comme l'état de santé ou la décision du médecin.

Aucune (un seul groupe de participants)
: tous les participants reçoivent le même traitement, aucune répartition n'est nécessaire.

Comment les traitements sont administrés aux participants
Les participants sont répartis en groupes distincts, chaque groupe recevant un traitement différent en même temps. Cela permet de comparer directement l'efficacité de plusieurs traitements.

Autres façons d'administrer les traitements
Groupe unique
: tous les participants reçoivent le même traitement.

Affectation croisée
: les participants passent d'un traitement à un autre au cours de l'étude.

Plan factoriel
: les participants reçoivent des combinaisons de traitements pour évaluer leurs interactions.

Plan séquentiel
: les traitements sont administrés successivement selon un ordre prédéterminé, pouvant varier selon la réaction du participant.

Autre type d'attribution
: L'attribution des traitements ne suit pas de schéma standard ni de protocole prédéfini.

Comment l'efficacité du traitement est contrôlée
Dans ce type d’étude, aucun participant ne reçoit de placebo. Tous reçoivent soit le traitement expérimental, soit un autre traitement actif, souvent le traitement de référence. Ce modèle permet de comparer les effets de deux interventions réelles, sans inclure de substance inactive.

Autres options possibles
Contrôlée par placebo
: un placebo est utilisé pour comparer les effets du traitement expérimental à ceux d'une substance inactive, ce qui permet d'évaluer son efficacité réelle.

Comment la nature du traitement est tenue confidentielle
Les participants, les chercheurs et les personnes chargées de l'évaluation des résultats ne savent pas quel traitement est administré. Cela permet de limiter les biais non seulement pendant l'étude, mais aussi au moment de l'analyse des résultats.

Autres méthodes de masquage
En ouvert
: tout le monde connaît le traitement administré.

Simple aveugle
: les participants ignorent le traitement reçu, mais les chercheurs le connaissent.

Double aveugle
: ni les participants ni les chercheurs ne savent quel traitement est administré.

Quadruple aveugle
: Les participants, les chercheurs, les personnes qui analysent les résultats et les professionnels de santé en charge du suivi ne savent pas non plus quel traitement est administré.

Éligibilité

Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.
Critères
Tout sexeLe sexe biologique des participants éligibles à s'inscrire.
À partir de 6 moisTranche d'âge des participants éligibles à participer.
Volontaires sains non autorisésIndique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.
Critères

Inclusion Criteria: * 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. * Subject is in good general health based on medical history. * Following application per designated product timeline shampoo hair using Johnson's baby shampoo (See figure 4 for shampoo image) to rinse out the product according to the study product its IFU. Subject agrees not to additionally shampoo, wash, or rinse their hair or scalp for 24-hours post treatment. * The subject agrees not to cut or chemically treat their hair while participating in the study. * Subject agrees to follow all study instructions, including attending all follow-up appointments. * Agree to not use any other anti-lice treatment or medicated hair grooming products for the duration of the study (through Day 10 visit). * The parent or legal guardian of a child must be willing to have other family members screened for head lice. If other household members are found to have head lice and are eligible, they must be either enrolled in the study OR receive the standard of care at the site and in the same manner as study participants. * Have a single place of residence or agree to remain at the current residence for the duration of the study. * The subject or his/her parent/legal guardian (from age 12-17), must give written informed consent, after having been informed orally and by written text about the benefits and potential risks of the trial, as well as information regarding the insurance, taken out to cover the subjects participating in the study. A caregiver must sign an informed consent agreement for children not old enough to do so. Children aged 6-11 years of age will be administered a child's assent form. Subject or his/her parent/legal guardian must be capable of understanding and providing written informed consent. Exclusion Criteria: * 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. * History of allergy or hypersensitivity to active ingredients, or constituents of the test products. * Subject with any visible skin/scalp condition at the treatment site which, in the opinion of the investigative personnel, will interfere with the evaluation of the test product. * Subjects with chronic scalp disorder. * Subject or his/her legal guardian who, in the opinion of the investigative personnel, do not understand the subject requirements for study participations and/or may be likely to exhibit poor compliance with the required visits. * Females who are pregnant or nursing. * Hair longer than waist length. * Subject suspected or known not to follow instructions * Previous participation in this study or participation in any other investigational trial within the preceding 14 days. * The subject is directly affiliated to the investigator site personnel and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted. * The subject is an Oystershell employee or is an employee of a third-party organizations involved in the study. * Exclude families with 4 or more household members. * People with dreadlocks or clip in hair that cannot be removed or a person who does not want to remove these. * Hair that is too difficult to work with, assessed by the study staff. * Families excluded where lice exist however family member declines enrollment in the study. * Subjects who are receiving, or are expected to receive, any antibiotic therapy during the study period will be excluded. * No more than one working subject per household may be excluded from evaluation if he is assessed as being lice by himself or caregiver. Only working male can be excluded from evaluation if individual is bald or hair no longer than half inch and deemed lice free by himself or another adult. * All household members of the subject, other than excluded male adult, must be screened for head lice by a licenced head lice professional. If additional household members are found to have head lice and meet the study criteria, they will be referred to LSRN Research and enrolled in study. If a household member declines enrollment, all family members will be excluded from the study.


Plan de l'étude

Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.
Groupes de traitement
Objectifs de l'étude
2 groupes d'intervention 

sont désignés dans cette étude

Cette étude ne comporte pas de groupe placebo. 

Groupes de traitement
Groupe I
Expérimental
Lice treatment with Elimax Green Lotion (Emogreen)

STEP 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.
Groupe II
Comparateur actif
Topical lice treatment with Walgreens Lice Killing Shampoo

Apply 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.
Objectifs de l'étude
Objectifs principaux

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.
Objectifs secondaires

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).

Determine efficacy of the investigational product for all baseline infestations (cure rate at day 1).

Determine efficacy of the investigational product for mild and moderate baseline infestations (cure rate at day 1).

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).

Global tolerability (general well-being and global tolerability of the test product) will be assessed by the blinded study staff at day 10. The global tolerability will be rated on a 4-category scale with: Score 1 = very good, Score 2 = good, Score 3 = moderate, Score 4 = poor. Evaluation at 10d after application.

To evaluate skin irritation by study staff (secondary infection, erythema, excoriation) on day 0, 1, 7 and 10. The following 4-category scale will be used: * Score 1 - None: No visible skin reaction. * Score 2 - Mild: Slight redness or dryness; with no swelling, peeling, or open sores; does not interfere with daily activities. * Score 3 - Moderate: Pronounced erythema, itching, or localized excoriation; may be associated with discomfort or require a non-prescription topical treatment. * Score 4 - Severe: Intense noticeable redness, edema, raw and/or broken skin (e.g. breakdown of skin with oozing or bleeding); may require medical intervention or lead to the discontinuation of the investigational product

To evaluate eye irritation by study staff on day 0, 1, 7 and 10. The following 4-category scale will be used: * Score 1 - None: No redness or irritation; the eyes appear normal. * Score 2 - Mild: Slight conjunctival redness or dryness; with no tearing or discomfort. * Score 3 - Moderate: Noticeable redness with possible tearing or discomfort; does not impair vision or require any treatment. * Score 4 - Severe: Apparent redness with significant irritation, tearing, or pain; possibly interferes with vision or requires medical treatment.

To evaluate characterization of safety and tolerability of the investigational product considering adverse events in the study population.

The esthetical properties of the investigational products will be evaluated to determine the satisfaction by the subjects with the products after application using a questionnaire about hair and scalp feeling, greasiness, hair look, shininess, and volume. With each question being scored on a scale from 1-4: * Score 1 = Strongly agree * Score 2 = Agree * Score 3 = Disagree * Score 4 = Strongly disagree

Centres d'étude

Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.
Cette étude comporte 1 site
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LSRN ResearchEnid, United StatesVoir le site

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