Dandruff Clinical Trial
Official title:
The Efficacy of Sodium Shale Oil Sulponate 1% Shampoo in the Treatment of Pityriasis Capitis
Dandruff, also known as Pityriasis capitis, is a common condition which affects the scalp of
almost half the post-pubertal population regardless of race and gender. It is said that
dandruff affects at least 50% of the world's adult population and about 15 - 20% of the
world's total population. Dandruff is usually marked by flaking as well as itching and
irritation of the scalp which can also lead to greasiness. Dandruff can lead to
physiological and psychological issues and can be very distressing and embarrassing for the
sufferer, causing low self esteem and social problems. Current treatment options for
dandruff include many over-the-counter preparations, anti-dandruff shampoos and topical
steroid applications which are accompanied by numerous adverse effects. According to Lunar
Pharmaceuticals Ichthyol® Pale is a sodium salt of pale sulphonated shale oil in aqueous
solution with anti-microbial properties which can combat dandruff helping with the causative
and symptomatic relief of this condition.
The aim of the study is to determine the efficacy of Sodium Shale Oil Sulponate 1% shampoo
in the treatment of Pityriasis capitis. This will be evaluated using the Adherent Scalp
Flaking Score (ASFS) grading and the Visual Analogue Scale (VAS).
Status | Completed |
Enrollment | 40 |
Est. completion date | July 2015 |
Est. primary completion date | July 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: - Between the ages of 18 and 45; - suffering from mild to moderate dandruff with itching, flaking, greasiness, irritation of the scalp and possible hair loss; - have a baseline Adherent Scalp Flaking Score grading ASFS score of = 24 and 7, and - have good general health. Exclusion Criteria: - Suffering from other conditions such as psoriasis, atopic dermatitis, contact dermatitis or tinea capitis; - diagnosed with systemic or chronic diseases; - pregnant or lactating; - currently on any chronic medication, or - currently on treatment for dandruff. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
South Africa | University of Johannesburg | Johannesburg | Gauteng |
Lead Sponsor | Collaborator |
---|---|
University of Johannesburg |
South Africa,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adherent Scalp Flaking Score (ASFS) | The Adherent Scalp Flaking Score will be conducted by the researcher on days 1,8 and 16. | 16 days. | No |
Secondary | Dandruff severity as measured by the Visual Analogue Scale (VAS) | Dandruff severity as measured by the Visual Analogue Scale will be scored by both the researcher and participant on days 1, 8 and 16. | 16 days. | No |
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