Comparison of the efficacy of a new medical device with a physical mode of action to Paranix anti-lice shampoo in the treatment of head lice infestation.
Pediculosis capitis or head lice infestation is a human medical condition caused by the infestation of the hair by the parasitic insect Pediculus humanus capitis (human head lice). When lice feed, they inject saliva into the scalp. The saliva is an anticoagulant which keeps blood from clotting making their feeding process easier. Many individuals experience an allergic reaction to the saliva, causing up to 50% of the population with head lice to itch. For this reason, the most common symptom of infestation is pruritus (itching) on the head. The bite reaction is very mild and it can be rarely seen between the hairs. In rare cases, the itch scratch cycle can lead to secondary infection. Swelling of the local lymph nodes and fever are rare. There are a range of interventions available for the management of head lice. The main stay of therapy has been largely dependent on insecticidal-based approaches for several decades. However, the accumulating evidence with resistance to frontline insecticidal treatments like pyrethrins, permethrin and malathion has led to a growing incentive to develop newer and more effective treatments to treat the condition safely \[3\]. Over the past couple of decades, alternative candidates have been introduced into the market, including products with a physical mode of action that works via dehydration and suffocation of the lice \[4-8\]. The tested product has been developed with the ambition to offer a complete and safe head lice treatment, highly effective against head lice and eggs, whilst also offering ultimate convenience in use - making treatment of head lice infestation easy, and effective in few minutes. This is a medical device, not yet on the market, with a physical mode of action of suffocation and dehydration. The comparator product, Paranix® Anti-Lice Shampoo, is a reference product with a physical mode of action, available on the market in Europe as a class I medical device. The main objective of the current study is to evaluate the efficacy and safety on head lice treatment of the device X92001919 versus Paranix® Anti-Lice Shampoo comparator.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
34
Treatment at Day 0, Day 3 and Day 7 with the Pulverize Dry Shampoo formulation (X92001919)
Treatment at Day 0 and Day 7 with the Paranix Anti-Lice Shampoo
Efficacy of Pulverize (X92001919) compared to the comparator Paranix Anti-Lice Shampo.
Evaluate the efficacy of Pulverize (X92001919) compared to the comparator Paranix Anti-Lice Shampoo on the treatment of head lice infestation, after one treatment consisting of 3 applications. Efficacy of the treatment will be defined as the cure rate at the end of day 10, corrected for re-infestation.
Time frame: 10 days
Efficacy comparison (uncorrected for re-infestation)
Evaluate and compare the efficacy for both products. (cure rate at the end of day 10, uncorrected for re-infestation).
Time frame: 10 days
Cure rate on day 3 and day 7
Evaluation of the cure rate on day 3 and day 7 in both separate groups, and comparison of both product effect after only one (on day 3) or two applications (day 7 for Pulverize versus day 10 for Paranix).
Time frame: day 3 for cure rate of first application day 7/day 10 for second application (depending on treatment).
Indirect efficacy on eggs and evaluate potential re-infestation
Presence of live lice and nymphs, for both groups and between groups, without combing on hair and close to scalp on day 0 (prior to treatment to assess severity of the infestation), day 3, day 7, and day 10. These evaluations will assess indirect efficacy on eggs and evaluate potential re-infestation.
Time frame: Treatment time (day 0 - day 10
General well-being of subject (Esthetical effect)
Analysis of subject's (or subject's parents/guardians) questionnaire at day 0 and day 7 to evaluate esthetical effect of the product. A comparison of the answers will be performed between the two products.
Time frame: Day 0 and day 7 of the study
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Safety by Adverse Events (AEs)
Number and evaluation of Adverse Events (AEs) reported during the study.
Time frame: Duration of the study (day 0 - day 10)
Local tolerability on 5-point scales
For both products, evaluation of local tolerability by the dermatologist on 5-point scales including dandruff state, greasy scalp, erythema, desquamation dryness, burning sensation, paraesthesia and pruritus and on 4 point-scales including skin irritation and eye irritation, on D0 (before and after product application), D3 (before and after application), D7 (before and after product application) and D10.
Time frame: Duration of study (day 0- day 10)
Global tolerability
For both products, assessment of global tolerability by the dermatologist on day 10 on a 4-point scale.
Time frame: Day 10