DandruffPhase 2NCT02448082
The Efficacy of Sodium Shale Oil Sulponate 1% Shampoo in the Treatment of Pityriasis Capitis
A Phase 2 study of Dandruff, run by University of Johannesburg at 1 site in South Africa.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Dandruff
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSouth Africa
- Study dates
- Oct 2014to Jul 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Africa1 site
University of Johannesburg
Johannesburg, Gauteng, 2094
About this study
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).
Read the 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.
- Conditions
- Dandruff
- Being tested
- Shampoo (inactive), Sodium shale oil sulponate 1% shampoo
- Keywords
- Dandruff, Pityriasis capitis, Ichthyol® Pale, Sodium shale oil sulponate 1%
- Medical subject headings
- Dandruff
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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%.
Sodium shale oil sulponate 1% shampooOther
Also called Ichthyol® Pale
Shampoo containing the active ingredient of sodium shale oil sulponate 1%.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Sodium shale oil sulponate 1% shampoo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherent Scalp Flaking Score (ASFS)
The Adherent Scalp Flaking Score will be conducted by the researcher on days 1,8 and 16.
Measured: 16 days.
Secondary outcomes (1)
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.
Measured: 16 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2015 (estimated)
- Study startOct 2014
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DandruffStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Johannesburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr J. Pellow, University of Johannesburg
- Investigators
- Neil Gower, M.TechHom, Study director, University of Johannesburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02448082
- Sponsor's protocol ID
- ZeenatMia201001496
- Status last verified
- May 2016
- First submitted
- 4 May 2015
- Last updated
- 19 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Sodium Shale Oil Sulponate 1% Shampoo in the Treatment of Pityriasis Capitis
- ClinicalTrials.gov ID
- NCT02448082
- Acronym / sponsor ID
- ZeenatMia201001496
- Conditions
- Dandruff
- Keywords
- Dandruff, Pityriasis capitis, Ichthyol® Pale, Sodium shale oil sulponate 1%
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of JohannesburgUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 19 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shampoo (inactive) | Placebo comparator | Other: Shampoo (inactive)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. |
| Sodium shale oil sulponate 1% shampoo | Experimental | Other: Sodium shale oil sulponate 1% shampooShampoo 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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%. | Other | Shampoo (inactive) |
| Sodium shale oil sulponate 1% shampooAlso: Ichthyol® PaleShampoo containing the active ingredient of sodium shale oil sulponate 1%. | Other | Sodium shale oil sulponate 1% shampoo |
Primary outcome
Adherent Scalp Flaking Score (ASFS)
Time frame: 16 days.
The Adherent Scalp Flaking Score will be conducted by the researcher on days 1,8 and 16.
1 secondary outcome
Dandruff severity as measured by the Visual Analogue Scale (VAS)
Time frame: 16 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neil Gower, M.TechHom study director
University of Johannesburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Dandruff, run by University of Johannesburg at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherent Scalp Flaking Score (ASFS) (time frame: 16 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2016.