Tension-type headaches.
Conditions
Interventions
Trade Name: 4head
Product Name: 4head
Product Code: FHED
Pharmaceutical Form: Cutaneous stick
INN or Proposed INN: Levo-menthol
Sponsors
Dermal Laboratories Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female subjects will be eligible for inclusion in the study provided they have a declared history of experiencing tension-type headaches at least twice weekly. 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: i) Subjects less than 18 years old. ii) Subjects with a history of known or suspected intolerance to menthol or levomenthol. iii) Subjects receiving any unlicensed drug within the last 30 days or scheduled to receive an investigative drug other than the study medication during the period of the study. iii) Subjects who have any other condition, whether being treated or not, which, in the opinion of the Investigator, may adversely influence their participation in the trial. iv) Female subjects, if they are possibly pregnant or breast-feeding and / or not using a medically approved form of contraception. v) Subjects considered unable or unlikely to be able to complete the questionnaire/diary or to attend the necessary final visit. vi) Subjects concurrently participating in any other test involving an Investigational Product. vii) Subjects who have participated in a research study in the previous 4 weeks involving the same skin site. viii) Subjects who have any skin pathology, scars, tattoos, or birthmarks at the test site likely to interfere with the study. ix) Subjects who are an employee of Sequani Clinical or Dermal Laboratories, or an immediate family member (partner, offspring, parents, siblings or sibling’s offspring) of an employee.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of the study is broadly twofold. In Part I, to be performed in a controlled laboratory setting, we aim to establish the average speed of onset, and duration, of the skin sensations felt after a single dose. In Part II, comprising an open-label evaluation when patients use the product to treat tension-type headaches occurring over period of at least 2 weeks, we aim to find out how many wipes they tend to use for each application, and the typical dosing interval. ;Secondary Objective: We also aim to determine subjects' overall level of satisfaction with using 4head, and to test their understanding of the safety information supplied in the Patient Information Leaflet. The latter arises because marketing companies now have a legal obligation to ‘user test’ their in-pack leaflets, and so opportunity is also being taken to obtain some feedback in this regard too. ; Primary end point(s): In Part 1, the analysis variables will be the time to onset, and duration of, the skin sensations. In Part 2, the analysis variables will be the most appropriate number of wipes per application, and the typical interval time between successive applications (both as reported by subjects), and subjects’ assessments of the effectiveness and acceptability of 4head™ in treating their headaches. | — |
Countries
United Kingdom
Outcome results
None listed