Pityriasis VersicolorPhase 4NCT04007237
The Comparative Assessment of Mycological Efficacy, Safety, Recurrence, and Cost-effectiveness of Selenium Sulfide 1.8% Shampoo Versus Ketoconazole 2% Shampoo in Pityriasis Versicolor: a Double-blind Randomized Controlled Trial
A Phase 4 study of Pityriasis Versicolor, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
There are several topical treatment for Pityriasis Versicolor including ketoconazole and selenium sulfide. Ketoconazole is a broad spectrum anti-fungal drug from imidazole group that has been reported to be effective in PV. Read more about this study
- Who is it for?
- Ages 12 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Pityriasis Versicolor
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Sep 2018to 30 Dec 2018
- Phase
- Phase 4
- 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 12 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Having PV characteristic skin lesions,proven by 20% KOH scraping test and Parker Blue-Black® ink, with the founding of short hyphae and group spores or short hyphae only
- willing to participate in the study by signing the written informed consent
- Subjects under the age of 18 with permission from parents or guardians.
Who cannot join
- A history of hypersensitivity to the ingredients of the shampoo tested.
- Having skin abnormalities with impaired skin integrity
- In the treatment of topical anti-fungal therapy for less than two weeks or systemic anti-fungal for less than one month.
- Pregnancy and breastfeeding.
- Patients with PV lesions on the face.
Trial locations and contacts
1 site in 1 country.
About this study
There are several topical treatment for Pityriasis Versicolor including ketoconazole and selenium sulfide. Ketoconazole is a broad spectrum anti-fungal drug from imidazole group that has been reported to be effective in PV. The study aimed to reveal the mycological efficacy, safety, recurrence and cost-effectiveness of selenium sulfide 1.8% shampoo (SeS2) and ketoconazole 2% shampoo in the treatment of pityriasis versicolor. A double blind randomized controlled trial was performed in patients with PV during September-December 2018. Patients who involved in this study were allocated to SeS2 or ketoconazole 2% based on block randomization. Physical examinations, scale provocation test, Wood lamp and potassium hydroxide (KOH) examination were conducted to evaluate the treatment response and side effects on 7th - 14th day. Intention to treat analysis was performed in this study. cost-effectiveness was analyzed by Incremental Cost-Effectiveness Ratio (ICER).
- Conditions
- Pityriasis Versicolor
- Being tested
- shampoo with different composition
- Keywords
- mycological efficacy, ketoconazole, selenium disulfide 1,8%, Pityriasis versicolor
- Medical subject headings
- Tinea Versicolor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
shampoo with different compositionDrug
To reveal the mycological efficacy, safety, recurrence and cost-effectiveness of selenium sulfide 1.8% shampoo (SeS2) and ketoconazole 2% shampoo in the treatment of pityriasis versicolor.
| Study group | Role | What they receive |
|---|---|---|
| Selsun Shampoo (SeS2 shampoo) | Experimental | Subject were given the SeS2 1.8% shampoo for 2 weeks. They should use it everyday, 10ml each time for 10 minutes. Evaluation was weekly and note for side effects and compliance Receives: Drug: shampoo with different composition |
| Ketoconazole shampoo | Active comparator | Subject were given the Ketoconazole 2% shampoo for 2 weeks. They should use it everyday, 10ml each time for 10 minutes. Evaluation was weekly and note for side effects and compliance Receives: Drug: shampoo with different composition |
What is being measured
The primary outcome is the main question the study is designed to answer.
mycology efficacy
skin scrapping with KOH test 20% and Parker Blue-Black® ink with the founding of short hyphae and group spores or short hypha only as a positive result
Measured: 7 days
mycology efficacy
skin scrapping with KOH test 20% and Parker Blue-Black® ink with the founding of short hyphae and group spores or short hypha only as a positive result
Measured: 14 days
compliance
the number of day in which a participant using the shampoo which was assigned for minimum 5 days or more and the remaining volume of shampoo does not exceed 25 ml.
Measured: 7 days
compliance
the number of day in which a participant using the shampoo which was assigned for minimum 5 days or more and the remaining volume of shampoo does not exceed 25 ml.
Measured: 14 days
side effect
based on clinical symptoms : itching, burning or stinging sensation. Assessed based on patient records in the diary and through interviews during control
Measured: 7 days
side effect
based on clinical symptoms : itching, burning or stinging sensation. Assessed based on patient records in the diary and through interviews during control
Measured: 14 days
cost-effectiveness
Cost calculations include administrative fees (registration and consultation of doctors), laboratory examinations, medical expenses and compensation for side effects adjusted for the duration of therapy. The results of the calculation of costs obtained are then linked to the negative outcome difference (KOH is still positive) or the value of absolute risk reduction (ARR) on day 14. So that cost efficacy is seen from Incremental Cost-Effectiveness Ratio
Measured: two weeks
recurrence
if the KOH test 20% give a positive result again
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start1 Sep 2018
- Primary completion30 Dec 2018
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pityriasis VersicolorStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fariz Nurwidya, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04007237
- Sponsor's protocol ID
- efficacy - PV
- Status last verified
- Jul 2019
- First submitted
- 15 Jun 2019
- Last updated
- 5 Jul 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparative Assessment of Mycological Efficacy, Safety, Recurrence, and Cost-effectiveness of Selenium Sulfide 1.8% Shampoo Versus Ketoconazole 2% Shampoo in Pityriasis Versicolor: a Double-blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04007237
- Acronym / sponsor ID
- efficacy - PV
- Conditions
- Pityriasis Versicolor
- Keywords
- mycological efficacy, ketoconazole, selenium disulfide 1,8%, Pityriasis versicolor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 5 Jul 2019 (actual)
- 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.
There are several topical treatment for Pityriasis Versicolor including ketoconazole and selenium sulfide. Ketoconazole is a broad spectrum anti-fungal drug from imidazole group that has been reported to be effective in PV. The study aimed to reveal the mycological efficacy, safety, recurrence and cost-effectiveness of selenium sulfide 1.8% shampoo (SeS2) and ketoconazole 2% shampoo in the treatment of pityriasis versicolor. A double blind randomized controlled trial was performed in patients with PV during September-December 2018. Patients who involved in this study were allocated to SeS2 or ketoconazole 2% based on block randomization. Physical examinations, scale provocation test, Wood lamp and potassium hydroxide (KOH) examination were conducted to evaluate the treatment response and side effects on 7th - 14th day. Intention to treat analysis was performed in this study. cost-effectiveness was analyzed by Incremental Cost-Effectiveness Ratio (ICER).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Selsun Shampoo (SeS2 shampoo) | Experimental | Drug: shampoo with different compositionSubject were given the SeS2 1.8% shampoo for 2 weeks. They should use it everyday, 10ml each time for 10 minutes. Evaluation was weekly and note for side effects and compliance |
| Ketoconazole shampoo | Active comparator | Drug: shampoo with different compositionSubject were given the Ketoconazole 2% shampoo for 2 weeks. They should use it everyday, 10ml each time for 10 minutes. Evaluation was weekly and note for side effects and compliance |
Who may qualify
- Ages
- 12 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Having PV characteristic skin lesions,proven by 20% KOH scraping test and Parker Blue-Black® ink, with the founding of short hyphae and group spores or short hyphae only
- willing to participate in the study by signing the written informed consent
- Subjects under the age of 18 with permission from parents or guardians.
Key exclusion criteria (5 listed)
- A history of hypersensitivity to the ingredients of the shampoo tested.
- Having skin abnormalities with impaired skin integrity
- In the treatment of topical anti-fungal therapy for less than two weeks or systemic anti-fungal for less than one month.
- Pregnancy and breastfeeding.
- Patients with PV lesions on the face.
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 with different compositionTo reveal the mycological efficacy, safety, recurrence and cost-effectiveness of selenium sulfide 1.8% shampoo (SeS2) and ketoconazole 2% shampoo in the treatment of pityriasis versicolor. | Drug | Ketoconazole shampoo, Selsun Shampoo (SeS2 shampoo) |
Primary outcome
mycology efficacy
Time frame: 7 days
skin scrapping with KOH test 20% and Parker Blue-Black® ink with the founding of short hyphae and group spores or short hypha only as a positive result
mycology efficacy
Time frame: 14 days
skin scrapping with KOH test 20% and Parker Blue-Black® ink with the founding of short hyphae and group spores or short hypha only as a positive result
compliance
Time frame: 7 days
the number of day in which a participant using the shampoo which was assigned for minimum 5 days or more and the remaining volume of shampoo does not exceed 25 ml.
compliance
Time frame: 14 days
the number of day in which a participant using the shampoo which was assigned for minimum 5 days or more and the remaining volume of shampoo does not exceed 25 ml.
side effect
Time frame: 7 days
based on clinical symptoms : itching, burning or stinging sensation. Assessed based on patient records in the diary and through interviews during control
side effect
Time frame: 14 days
based on clinical symptoms : itching, burning or stinging sensation. Assessed based on patient records in the diary and through interviews during control
cost-effectiveness
Time frame: two weeks
Cost calculations include administrative fees (registration and consultation of doctors), laboratory examinations, medical expenses and compensation for side effects adjusted for the duration of therapy. The results of the calculation of costs obtained are then linked to the negative outcome difference (KOH is still positive) or the value of absolute risk reduction (ARR) on day 14. So that cost efficacy is seen from Incremental Cost-Effectiveness Ratio
recurrence
Time frame: 1 month
if the KOH test 20% give a positive result again
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 5 Jul 2019.
Related trials for Pityriasis Versicolor
Not yet recruitingPhase 4
Mycological Efficacy and Safety of Ketoconazole 2% Shampoo With a Seven-Day Versus Three-Day Treatment Duration in Pityriasis Versicolor
Pityriasis Versicolor
Not yet recruitingPhase 1/2
Comparative Efficacy of Topical 1% Clotrimazole vs Oral Itraconazole in the Treatment of Pityriasis Versicolor
Pityriasis Versicolor
Not yet recruitingPhase 4
Comparison of the Efficacy of Topical Luliconazole 2% Cream vs Topical Ketoconazole 1% Cream in the Treatment of Pityriasis Versicolor.
Pityriasis Versicolor
RecruitingPhase 1
A Study of the Clinical Efficacy and Safety of 20% Cassia Alata Extract Against Tinea Versicolor
Tinea Versicolor, Pityriasis Versicolor
RecruitingPhase 4
Comparison of Efficacy of Oral Fluconazole Versus Oral Itraconazole in the Treatment of Pityriasis Versicolor
Pityriasis Versicolor
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study of Pityriasis Versicolor, run by Universitas Indonesia at 1 site in Indonesia.
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 3 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 5 Jul 2019. 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 Indonesia. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
mycology efficacy (time frame: 7 days). The study lists 8 primary outcomes in all. 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 5 Jul 2019; AzTrials last refreshed its copy on 8 Nov 2026.