The Efficacy of Sodium Shale Oil Sulponate 1% Shampoo in the Treatment of Pityriasis Capitis
Condition: Dandruff
MeSH terms: Pityriasis; Dandruff
Study type: Interventional
Phase: Phase 2

Summary: 
      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).
    

Detailed description: 
      The research study will be performed as a 16 day double-blind placebo controlled study
      design. The research will be conducted at the University of Johannesburg, Doornfontein
      Campus. Forty participants, both males and females, between the ages of 18 and 45 years will
      be recruited via advertisements placed at the University of Johannesburg Health Clinic,
      Doornfontein Campus, at hair salons and gyms situated around Gauteng (with relevant
      permission given).

      The initial consult (day zero) will consist of a full description and discussion of the
      research method with the participant. Thereafter, the participant will be requested to read a
      participant information form and sign a consent form. An evaluation, based on the inclusion
      and exclusion criteria, to determine whether the participant meets the criteria for the
      research study will be performed. A physical and general assessment will be conducted to
      determine vital signs and health status respectively. Thereafter, the participant's dandruff
      will be evaluated using the Adherent Scalp Flaking Score (ASFS) grading, completed by the
      researcher, and the Visual Analogue Scale (VAS), completed by both the participant and the
      researcher.

      The participants will be divided into two groups by means of match pairing, according to
      severity of dandruff. Based on the determined group, the participants will be given either
      the experimental (with active anti-dandruff agents) or control (without active anti-dandruff
      agents) shampoo together with the directions for the use of the shampoo at the first
      consultation. At the second consultation, which will occur on day 8, the participant's scalp
      will be evaluated using the ASFS grading, completed by the researcher, and the VAS, completed
      by both the participant and the researcher. On day 16 (final consult), a final evaluation of
      the participant's dandruff will be done, using the same method described as with the second
      consultation. At each consult, all results will be recorded. Participants will be requested
      to wash the scalp once every second day, starting from day 1 to day 16. Reminders to wash the
      scalp will be sent to each participant via a text message the night before they are due to
      wash their hair.

      On completion of the study, all data will be collated and an Exploratory Data Analysis (EDA)
      will be performed to determine group normality and comparability of the data. Parametric
      intergroup analysis will include the independent T-sample test, followed by intragroup
      analysis using the ANOVA measurement. Non-parametric intergroup analysis will include the
      Mann-Whitney U test, while intragroup analysis will involve the Friedman or the Wilcoxon
      Signed-Ranks test.

      Positive results of the study may yield an effective and safe treatment option for dandruff.
    

Intervention name(s): Shampoo (inactive); Sodium shale oil sulponate 1% shampoo
Intervention type(s): Other; Other
Intervention description(s): Shampoo which is made to look and feel the same as the experimental shampoo but does not contain the active ingredient of sodium shale oil sulponate 1%.; Shampoo containing the active ingredient of sodium shale oil sulponate 1%.
Other intervention name(s): Ichthyol® Pale
Intervention MeSH terms: Ichthammol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dandruff; Pityriasis capitis; Ichthyol® Pale; Sodium shale oil sulponate 1%