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: 9.1 Level: LLT Classification code 10034208 Term: Pediculosis
Conditions
Interventions
Trade Name: Diffusil H Forte
Pharmaceutical Form: Cutaneous spray*
INN or Proposed INN: carbaryl
CAS Number: 63-25-2
Concentration unit: % (W/W) percent weight/weight
Concentration type: equal
Concent
Sponsors
Lybar a.s.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Czech Republic
Outcome results
None listed