Safety and Efficacy of a Head Lice Shampoo

The primary objective was to show, that the cure rate after local application of Test head lice shampoo is better than a predefined limit. It had to be shown, that the Test head lice shampoo achieved a cure rate superior to 70% (cure rate at the end of day 10, corrected for re-infestation).

The secondary objective was the comparison of the cure rate of the test product with the reference product by using different endpoints. It should be shown that the cure rate on day 10 for the reference product for all baseline infestations is better than the pre-defined limit of 70%.

The secondary objective was the comparison of the cure rate of the test product with the reference product by using different endpoints. It should be shown that the test head lice shampoo has a cure rate superior to the reference.

The secondary objective was the comparison of the cure rate of the test product with the reference product by using different endpoints. It should be shown that in case, that superiority could not be shown, the test head lice shampoo is at least not-inferior to the reference. A non-inferiority margin of 7.5% was defined.

Subjective symptoms (burning, paraesthesia, pruritus) after administration of the investigational products were rated by the patients on a 4-category scale on day 0 and day 7 (0h, 1h p.a.) directly after study drug application as well as on day 1 and day 10 p.a.:

Score 1 = no Score 2 = mild Score 3 = moderate Score 4 = severe

Global tolerability was assessed by blinded study staff and by the patient or his/her guardian at day 10. The study staff performed the rating in each case prior to the assessment by the patient to avoid bias. Afterwards, the patient self-assessed the global tolerability.

The global tolerability was rated on a 4-category scale with:

Score 1 = very good Score 2 = good Score 3 = moderate Score 4 = poor

To investigate a potential irritation of the eyes due to the treatment, the trained and blinded study staff assessed the severity of redness of both eyes within 1 hour before first treatment (baseline), as well as directly after study drug application and after the end of treatment on study day 0, day 1, day 7 (pre-treatment, 0h and 1h p.a.) and on day 10.

For the assessment of eyes the following 4-category scale as mentioned above were used.

Score 1 = no Score 2 = mild Score 3 = moderate Score 4 = severe

Skin irritation (secondary infection, erythema, excoriation) was assessed by blinded and trained study staff within 1 hour before first treatment (baseline), as well as directly after study drug application and after the end of treatment on study day 0, day 1, day 7 (pre-treatment, 0h and 1h p.a.) and on day 10 .

For the assessment of skin irritation the following 4-category scale as mentioned above were used.

Score 1 = no Score 2 = mild Score 3 = moderate Score 4 = severe

The esthetical properties of the investigational products were evaluated to determine the satisfaction by the patients with the product after application using a questionnaire about hair and scalp feeling, greasiness, hair look, shininess and volume. The questioning was performed on day 0 and day 7 after treatment and drying the hair.

Six questions al with Score 1-4:

Score 1 = strongly agree Score 2 = agree Score 3 = disagree Score 4 = strongly disagree

An Adverse Event (AE) is any unintended or unfavourable sign (including an abnormal finding), symptom or disease occurring in a subject after signing the informed consent until the last study visit, whether or not the event is believed to be causally related to study medication (IMP) or comparative compound. This definition includes any worsening of conditions that were present at the time of entry into the study (signing of the informedconsent) (see International Conference on Harmonization (ICH-E2A). AEs occurring after signing the informed consent but before administration of study medication are defined as non-treatment-emergent events. Those events are evaluated separately because in these cases a causal relationship with the study medication can be excluded.

The severity of head lice infestation was judged on a 4-point severity scale:

• 0 = no relevant infestation (0-4 lice and/or nymph present);
• 1 = mild (5-9 lice and/or nymphs present);
• 2 = moderate (10-24 lice and/or nymphs present);
• 3 = severe (≥ 25 lice and/or nymphs present)