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

ybar a.s.0 个研究点开始时间: 2007年8月7日最近更新: 2017年10月2日

适应症

试验速览

暂无简介。

•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

•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

发起方

ybar a.s.