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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02448082
Other study ID # ZeenatMia201001496
Secondary ID
Status Completed
Phase Phase 2
First received May 4, 2015
Last updated May 18, 2016
Start date October 2014
Est. completion date July 2015

Study information

Verified date May 2016
Source University of Johannesburg
Contact n/a
Is FDA regulated No
Health authority South Africa: National Health Research Ethics Council
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

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.

Study Design

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


Related Conditions & MeSH terms


Intervention

Other:
Shampoo (inactive)
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%.
Sodium shale oil sulponate 1% shampoo
Shampoo containing the active ingredient of sodium shale oil sulponate 1%.

Locations

Country Name City State
South Africa University of Johannesburg Johannesburg Gauteng

Sponsors (1)

Lead Sponsor Collaborator
University of Johannesburg

Country where clinical trial is conducted

South Africa, 

Outcome

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
See also
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Completed NCT06436495 - Methodology Validation: Correlating Adherent Scalp Flaking Score (ASFS) With Phototrichogram for Scalp Dandruff Evaluation in Adult Subjects N/A
Recruiting NCT05319444 - Cleansing Device for the Treatment of Scalp and Hair Conditions N/A
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