The present study is set-up to compare in vivo clinical performance and safety of the test product (X92001752) versus 3 other pediculicides (2 medical devices and 1 conventional pesticide).
The present study is set-up to compare in vivo clinical performance and safety of the test product versus a) RID Super Max Solution (oligodecene oil), Nix crème (1% permethrin), and Pouxit Végétal (fatty acid salts). 220 subjects (n=55 per treatment group) with confirmed diagnosis of head lice infestation will be included. To support safety, local and global tolerability, skin and ocular irritation will be assessed and adverse events (AEs) will be registered.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
220
The test product is a lotion to be applied on dry hair for 10 minutes and then washed out using shampoo. The product is to be applied on Day 0 and repeated again on Day 7.
RID Super Max Solution is a lotion to be applied on dry hair for 10 minutes and then washed out using shampoo. The product is to be applied on Day 0 and repeated again on Day 7.
Nix crème must be applied on dry hair for 10 minutes and then washed out with water. The product is to be applied on Day 0 and repeated again on Day 7.
South Fla. Family Health & Research Ctr.LLC
Plantation, Florida, United States
RECRUITINGNumber of Subjects That Are Lice-free After 2 Treatments With Test Product (Including All Baseline Infestations).
Clinical efficacy is reflected by the % of subjects that are lice-free after 2 topical applications (at day 0 \& day 7 respectively) of the test product. In this analysis, all baseline infestations (mild, moderate, severe) have been included. Assessment is performed at study end (visit 4, day 10). A mild infestation corresponds to 5-9 lice and/or nymphs A moderate infestation corresponds to 10-24 lice and/or nymphs A severe infestation corresponds to 25 or more lice and/or nymphs
Time frame: Day 10
Number of Subjects That Are Lice-free After 2 Treatments With RID Super Max Solution (Including All Baseline Infestations).
Clinical efficacy is reflected by the % of subjects that are lice-free after 2 topical applications (at day 0 \& day 7 respectively) of RID Super Max Solution. In this analysis, all baseline infestations (mild, moderate, severe) have been included. Assessment is performed at study end (visit 4, day 10). A mild infestation corresponds to 5-9 lice and/or nymphs A moderate infestation corresponds to 10-24 lice and/or nymphs A severe infestation corresponds to 25 or more lice and/or nymphs
Time frame: Day 10
Number of Subjects That Are Lice-free After 2 Treatments With Nix crème (Including All Baseline Infestations).
Clinical efficacy is reflected by the % of subjects that are lice-free after 2 topical applications (at day 0 \& day 7 respectively) of Nix crème. In this analysis, all baseline infestations (mild, moderate, severe) have been included. Assessment is performed at study end (visit 4, day 10). A mild infestation corresponds to 5-9 lice and/or nymphs A moderate infestation corresponds to 10-24 lice and/or nymphs A severe infestation corresponds to 25 or more lice and/or nymphs
Time frame: Day 10
Number of Subjects That Are Lice-free After 1 Treatment With Pouxit Végétal (Including All Baseline Infestations).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Pouxit Végétal must be applied on dry hair for 30 minutes and then washed out using shampoo. According to the instructions for use, only 1 treatment must be performed.
Clinical efficacy is reflected by the % of subjects that are lice-free after 1 topical applications (at day 0) of Pouxit Végétal. In this analysis, all baseline infestations (mild, moderate, severe) have been included. Assessment is performed at day 7 (last visit). A mild infestation corresponds to 5-9 lice and/or nymphs A moderate infestation corresponds to 10-24 lice and/or nymphs A severe infestation corresponds to 25 or more lice and/or nymphs
Time frame: Day 10
Effect of All Investigational Treatments on Pruritus (Local Tolerability Parameter), as Assessed by a Blinded Clinical Investigator.
The occurrence and degree of pruritus is rated by the blinded clinical investigator at each visit, using the following scores: none (best outcome), mild, moderate, and severe (worst outcome). None: the scalp does not itch; Mild: occasional episodes of itching, not bothersome; Moderate: frequent, several times a day, bothersome; Severe: nearly constant, frequent scratching, very bothersome.
Time frame: Day 0, Day 1, Day 7, Day 10
Effect of All Investigational Treatments on Scalp Excoriation (Local Tolerability Parameter), as Assessed by a Blinded Clinical Investigator.
The occurrence and degree of scalp excoriation (breaking of the skin, usually caused by scratching) is rated by the blinded clinical investigator at each visit, using the following scores: none (best outcome), mild, moderate, and severe (worst outcome). None: no broken skin on the scalp; Mild: one or two areas on the scalp on which skin is broken; Moderate: more than two separate areas of the scalp with broken skin but not generalized across the scalp; Severe: widespread breaking of the skin involving most of the scalp.
Time frame: Day 0, Day 1, Day 7, Day 10
Effect of All Investigational Treatments on Paraesthesia (Local Tolerability Parameter), as Assessed by a Blinded Clinical Investigator.
The occurrence and degree of paraesthesia (tingling or prickling sensation) is rated by the blinded clinical investigator at each visit, using the following scores: none (best outcome), mild, moderate, and severe (worst outcome). None: no tingling or prickling sensation; Mild: occasional tingling or prickling sensation; Moderate: frequent tingling or prickling sensation; Severe: nearly constant tingling or prickling sensation.
Time frame: Day 0, Day 1, Day 7, Day 10
Effect of All Investigational Treatments on Skin Erythema (Local Tolerability Parameter), as Assessed by a Blinded Clinical Investigator.
The occurrence and degree of skin erythema (redness of the scalp) is rated by the blinded clinical investigator at each visit, using the following scores: none (best outcome), mild, moderate, and severe (worst outcome). None: no redness of the scalp; Mild: faint, barely perceptible erythema with limited distribution; Moderate: diffuse pink areas of scalp are readily visible; Severe: large areas of the scalp are red.
Time frame: Day 0, Day 1, Day 7, Day 10
Effect of All Investigational Treatments on Pyroderma (Local Tolerability Parameter), as Assessed by a Blinded Clinical Investigator.
The occurrence and degree of pyroderma (sores filled with clear fluid, pus or crusting) is rated by the blinded clinical investigator at each visit, using the following scores: none (best outcome), mild, moderate, and severe (worst outcome). None: no lesions visible on the scalp; Mild: one or two lesions visible with crusting or other evidence of infection; Moderate: presence of more than two lesions with crusting or other evidence of infection, but not generalized across the scalp; Severe: lesions with crusting or other evidence of infection, involving most of the scalp.
Time frame: Day 0, Day 1, Day 7, Day 10
Effect of All Investigational Treatments on Eye Irritation, as Assessed by a Blinded Clinical Investigator.
The occurrence and degree of eye irritation (stinging, burning sensation, and/or pain) is rated by the blinded clinical investigator at each visit, using the following scores: none (best outcome), mild, moderate, and severe (worst outcome). None: no stinging, burning or pain Mild: slight mild stinging, burning or pain Moderate: moderate stinging, burning or pain Severe: severe stinging, burning or pain.
Time frame: Day 0, Day 1, Day 7, Day 10
Global Tolerability, Evaluated at Study End (Visit 4, Day 10)
Global tolerability is defined as the general well-being and comfort of the subjects. This parameter is assessed at day 10 in subjects, treated with either test product or reference product, respectively. The subject is asked to score his general feeling at study end and must provide a justification for his/her answer. Scoring was performed as follows: very good (best case), good, moderate, or poor (worst case).
Time frame: day 10
Assessment of Adverse Events Occurring After 1 and/or 2 Treatments With Both Investigational Products.
Recording Adverse Events and investigating the relationship with the treatment. At each visit (D0: first treatment; D1: 24h post-treatment assessment; D7: second treatment; D10: final assessment), the clinical staff is recording adverse events (if any) and evaluates the correlation with the treatment.
Time frame: Study period (10 days) + in case of adverse events: clinical staff will monitor the trial subject's safety from the occurrence of an AE until recovery, return to baseline or a stable state will be achieved.