The two severe dandruff conditions to be investigated in this study are pityriasis capitis and seborrhoeic dermatitis. MedDRA version: 14.1 Level: PT Classification code 10011859 Term: Dandruff System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 14.1 Level: LLT Classification code 10039794 Term: Seborrhoeic dermatitis capitis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Product Name: Terbicol Shampoo
Pharmaceutical Form: Shampoo
INN or Proposed INN: Terbinafine
CAS Number: 78628-80-5
Concentration unit: % (W/W) percent weight/weight
Concentration type: equal
Concentr
Sponsors
Dermal Laboratories
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be eligible for inclusion into the washout period, the patient must: i)be 14 years of age or older. ii)have a history of severe dandruff for a minimum of the last two months. iii)have an overall dandruff severity score (ODSS) of 35 or more (out of a maximum of 80). iv)be prepared to attend the clinic twice a week for a total of 7 weeks (14 visits in total). v)be prepared to have their hair washed by a technician at each study centre visit. vi)be willing to wash their hair only with their allocated Johnson's Baby shampoo at home, for the entire study period. vii)not tint, perm or colour their hair during the study period. viii)not commence use of any new conditioner or styling products that they do not use normally. ix)not have their hair styled in such a way as to prevent scalp assessment. After washout, to be eligible for recruitment into the treatment period: i)The patient’s overall dandruff severity score must still a minimum of 35 (out of a maximum of 80). Are the trial subjects under 18? yes Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 16
Exclusion criteria
Exclusion criteria: i) Patients who usually wash their hair less than twice weekly. ii)Patients with hair that is considered by the Investigator to be difficult to part readily for the purpose of scalp assessments (e.g. dreadlocks, braids, cornrows etc). iii) Patients with a history of intolerance or skin sensitivity to any of the ingredients of the study shampoos (treatment shampoos or Johnson's Baby Shampoo). iv) Patients who have applied topical corticosteroids to their scalp condition within the 4 weeks prior to study entry. v) Patients who have taken systemic treatment for any dermatosis within the previous 2 weeks prior to study entry. vi) Patients with systemic diseases which, in the opinion of the Investigator, may adversely influence their participation in the trial. vii) Patients who have received any unlicensed drug within the last 30 days or who are scheduled to receive an investigative drug other than the study medication during the period of the study. viii) Patients who have psoriasis, discoid lupus erythematosus or lichen simplex chronicus, or who are immunocompromised. ix) Female patients who are pregnant or lactating (although there are no particular safety concerns in these patient groups, it is generally inappropriate for them to participate in clinical trials without overriding justification). x) Patients considered unable or unlikely to attend the necessary follow-up visits. xi) Patients with another member of the household already enrolled in the study (this is to avoid possible mix up between assigned treatments).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The primary outcome measure will be the improvement from baseline (end of washout period) in the overall dandruff severity score (ODSS) after 4 weeks of treatment, based on the flaking and scaliness, as measured by the Investigator. This method of assessment is consistent with published studies investigating shampoos for the treatment of pityriasis capitis and seborrhoeic dermatitis. ;Main Objective: The primary objective is to find out if an antifungal shampoo is an effective treatment for the severe dandruff conditions pityriasis capitis and seborrhoeic dermatitis when used twice weekly in a study centre setting. The safety aspects of using the shampoo will also be investigated.;Secondary Objective: The secondary objectives are to find out if the study shampoo can induce an improvement in scalp erythema (redness and inflammation), as well as find out the patients' opinion as to whether the shampoo is effective in treating their symptoms of itching and flaking skin, which are associated with severe dandruff conditions.;Timepoint(s) of evaluation of this end point: ODSS will be measured at the start of treatment and after 4 weeks of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 1. Investigator assessment of erythema at baseline and after 2 and 4 weeks of treatment 2. Patient self-assessment of improvement in dandruff severity after 2 and 4 weeks of treatment 3. Patient self-assessment of itching at baseline and after 2 and 4 weeks of treatment;Secondary end point(s): 1. Investigator assessment of erythema The erythema secondary efficacy parameter will be the improvement from baseline (end of washout period) in the severity of erythema after 4 weeks of treatment, as scored by the Investigator. As for the overall dandruff severity score, the severity of erythema will be assessed by the Investigator before the study centre hair wash is performed, and will take place under controlled lighting conditions. The severity of erythema will be assessed by the investigator at the start of the treatment period, and after 2 and 4 weeks of treatment, using the 5 point scoring system below: 0=clear, 1=mild (faint erythema), 2=moderate (definite erythema), 3=severe (definite erythema with some inflammation), 4=very severe (definite erythema with severe inflammation) 2. Patients’ self-assessed improvement in dandruff severity after 4 weeks of treatment All patients will be asked their own impressions of their condition at the 2 and 4 week visits compared to the start of the treatment period (i.e. end of washout), in terms of dandruff severity, using the following scale: 0=completely cleared, 1=almost cleared, 2=significant improvement 3=some improvement, 4=no difference, 5=some deterioration 6=significant deterioration, 7=considerably worsened condition The percentage of patients with self-assessed dandruff severity improvement score of 2 (=significant improvement), 1 (=almost cleared) and 0 (=completely cleared) after 4 weeks of treatment will be the self-assessed severity secondary outcome. 3. Improvement in patients’ self-assessed pruritus after 4 weeks of treatment At recruitment, 2 weeks and 4 weeks, pat | — |
Countries
United Kingdom
Contacts
Public ContactRees
Dermal Laboratories
Outcome results
None listed