Clinical study phase III evaluating the safety of Diffusil H Forte spray.

Phase 1

• Conditions: This is an open-label clinical study evaluating the safety of Diffusil H Forte spray in people with pediculosis or in increased risk of infection of pediculosis.; MedDRA version: 9.1Level: LLTClassification code 10034208Term: Pediculosis

• Registration Number: EUCTR2007-002463-27-CZ
• Lead Sponsor: ybar a.s.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08-07
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

a)patients with pediculosis or in increased risk of pediculosis
b)patients or their legal representative able and willing to give written informed consent
c)patients or their legal representative able and willing to comply with the requirements of the study protocol
d)people of 6-70 years, male and female

Additional Inclusion Criteria for subjects to be included in efficacy evaluation:
e)positive dry combing test at Visit 1
f)feasibility of the dry combing test

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

a)acute conjunctivitis
b)clinical signs of eczema exacerbation
c)contact eczema in anamnesis
d)any local scalp treatment influencing the evaluation of safety
e)history of allergic reaction to any ingredient of the tested product
f)history of sensitivity to hair shampoo and hair conditioners
g)previous treatment with anti-lice products 2 weeks prior to Visit
h)use of antihistaminics within 3 days prior Visit 1
i)participating in another clinical trial within 4 weeks prior to Visit 1
j)pregnancy or breast-feeding
k)hairdressing such as bleaches, perm or dying

Additional Exclusion Criteria for subject to be included in efficacy evaluation:
l)any scalp condition that makes impossible the feasibility of the dry combing test
m)concomitant treatment influencing the evaluation of treatment efficacy such as use of trimethoprim or cotrimoxazol within 4 weeks prior to Visit 1

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To identify and evaluate adverse properties of Diffusil H Forte spray that may have relevance to its human safety.;Secondary Objective: To evaluate the clinical efficacy of Diffusil H Forte spray in people with pediculosis confirmed with a dry combing test under the conditions of this clinical trial.;Primary end point(s): The evaluation of safety of Diffusil H Forte spray in pediculosis treatment.