Seborrhoeic dermatitis and pityriasis capitis of the scalp.
Conditions
Interventions
Product Name: Ketocol Lotion
Product Code: KCSA
Pharmaceutical Form: Cutaneous solution
INN or Proposed INN: Approved INN = Ketoconazole
Sponsors
Dermal Laboratories Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Aged 18 years and above presenting with pityriasis capitis. Pityriasis capitis (severe dandruff) is defined, for study purposes, as having a history of scalp itching and dandruff for a minimum of the previous two months, and having, on examination, diffuse or patchy scaling areas of the scalp with or without accompanying erythema and which is clearly not psoriasis. A global severity rating of at least 8 (maximum score 20). Patients willing to refrain from using any other treatments and prepared to use only the study shampoo and Johnson's Baby shampoo for their scalp for the duration of the study. Are the trial subjects under 18? 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) Patients with excoriated/broken skin on their scalp. ii) Patients with a history of intolerance or skin sensitivity to any of the ingredients of the investigational shampoos and lotions. iii) Patients with a history of intolerance or skin sensitivity to any of the ingredients of Johnson's Baby shampoo. iv) Patients who have received systemic treatment for any dermatosis in the previous 2 weeks. v) Patients who have used steroids for their scalp condition within the previous 4 weeks. vi) 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. vii) Patients with systemic diseases which, in the opinion ofthe investigator, may adversely influence their participation in the trial. viii) 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). ix) Patients considered unable or unlikely to attend the necessary follow-up visits. x) Patients who are immunocompromised or taking immunosuppresants. xi) Patients with psoriasis, discoid lupus erythematosus or lichen simplex chronicus.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate Ketocol Lotion is clinically significantly more effective than placebo in the treatment of seborrhoeic dermatitis and pityriasis capitis.; Secondary Objective: To demonstrate Ketocol Lotion is "non-inferior" in clinical efficacy compared to Nizoral Shampoo. To investigate possible discoloration of hair and skin associated with the use of Ketocol Lotion (this possibility arises owing to the existence of a warning to this effect in the approved SPC for Nizoral Shampoo), as requested by the MHRA. ;Primary end point(s): Change in global disease severity score after 4 weeks of treatment. | — |
Countries
United Kingdom
Outcome results
None listed