This is a randomized, double-blind, placebo-controlled clinical study on efficacy of Diffusil H Forte spray in people with pediculosis. MedDRA version: 9.1 Level: LLT Classification code 10034208 Term: Pediculosis
Conditions
Interventions
Product Name: Diffusil H Forte
Product Code: Not available
Pharmaceutical Form: Cutaneous spray*
INN or Proposed INN: carbaryl
CAS Number: 63-25-2
Current Sponsor code: not available
Concentration uni
Sponsors
Lybar a.s.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a)patients with pediculosis confirmed by a positive dry combing test at Visit 1 b)patients able and willing to give written informed consent c)patients able and willing to comply with the requirements of the study protocol d)feasibility of the dry combing test e)age 18- 70 years, male and female Are the trial subjects under 18? no 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)any scalp condition that makes impossible the feasibility of the dry combing test b)acute conjunctivitis c)clinical signs of eczema exacerbation d)contact eczema in anamnesis e)history of severe allergic or anaphylactic reactions to any ingredients of the tested products f)history of sensitivity to hair shampoo and conditioners g)previous treatment with anti-lice products 2 weeks prior to Visit 1 h)concomitant treatment influencing the evaluation of efficacy such as use of trimethoprim or cotrimoxazol within 4 weeks prior to Visit 1 i)use of antihistaminics within 3 days prior Visit 1 j)participating in another clinical trial within 4 weeks prior to Visit 1 k)pregnancy or breast-feeding l)hairdressing such as bleaches, perm or dying
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the superiority of Diffusil H Forte spray over a placebo in pediculosis treatment after two applications 9 days apart.;Secondary Objective: 1)To determine the clinical efficacy of Diffusil H Forte spray in pediculosis treatment under the conditions of this clinical trial. 2)To evaluate the safety and tolerance of Diffusil H Forte spray in pediculosis treatment. ;Primary end point(s): The efficacy parameter defined as the cure rate after the treatment | — |
Countries
Czech Republic
Outcome results
None listed