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).
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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