Scalp lotion for the treatment of pityriasis capitis (severe dandruff) and seborrhoeic dermatitis. - Pityriasis capitis scalp lotion trial.

Phase 1

• Conditions: Seborrhoeic dermatitis and pityriasis capitis of the scalp.

• Registration Number: EUCTR2004-005085-21-GB
• Lead Sponsor: Dermal Laboratories Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-12-03
• Study Completion: 2009-11-03
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate Ketocol Lotion is clinically significantly more effective than placebo in the treatment of seborrhoeic dermatitis and pityriasis capitis.;<br> Secondary Objective: To demonstrate Ketocol Lotion is non-inferior in clinical efficacy compared to Nizoral Shampoo.<br><br> 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.<br> ;Primary end point(s): Change in global disease severity score after 4 weeks of treatment.