NCT02448082

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2014

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 19, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

May 19, 2016

Status Verified

May 1, 2016

Enrollment Period

9 months

First QC Date

May 4, 2015

Last Update Submit

May 18, 2016

Conditions

Dandruff

Keywords

DandruffPityriasis capitisIchthyol® PaleSodium shale oil sulponate 1%

Outcome Measures

Primary Outcomes (1)

  • Adherent Scalp Flaking Score (ASFS)

    The Adherent Scalp Flaking Score will be conducted by the researcher on days 1,8 and 16.

    16 days.

Secondary Outcomes (1)

  • Dandruff severity as measured by the Visual Analogue Scale (VAS)

    16 days.

Study Arms (2)

Shampoo (inactive)

PLACEBO COMPARATOR

Shampoo containing no active anti-dandruff ingredients will be used to wash the participants' hair every second day, starting from day 1 to day 15. Each participant in the placebo group will wash their hair with 25ml of the placebo shampoo per hair washing session.

Other: Shampoo (inactive)

Sodium shale oil sulponate 1% shampoo

EXPERIMENTAL

Shampoo containing sodium shale oil sulponate 1% will be used to wash the participants' hair every second day, starting from day 1 to day 15. Each participant in the experimental group will wash their hair with 25ml of the sodium shale oil sulponate 1% shampoo per hair washing session.

Other: Sodium shale oil sulponate 1% shampoo

Interventions

Shampoo (inactive)OTHER

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 (inactive)
Sodium shale oil sulponate 1% shampooOTHER

Shampoo containing the active ingredient of sodium shale oil sulponate 1%.

Also known as: Ichthyol® Pale
Sodium shale oil sulponate 1% shampoo

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Johannesburg

Johannesburg, Gauteng, 2094, South Africa

Location

MeSH Terms

Conditions

Dandruff

Condition Hierarchy (Ancestors)

DermatitisSkin DiseasesSkin and Connective Tissue DiseasesScalp Dermatoses

Study Officials

  • Neil Gower, M.TechHom

    University of Johannesburg

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Neil Gower

Study Record Dates

First Submitted

May 4, 2015

First Posted

May 19, 2015

Study Start

October 1, 2014

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

May 19, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations

ZA(1)