Pityriasis VersicolorPhase 4NCT07471178
Mycological Efficacy and Safety of Ketoconazole 2% Shampoo With a Seven-Day Versus Three-Day Treatment Duration in Pityriasis Versicolor
A Phase 4 study of Pityriasis Versicolor, run by Fakultas Kedokteran Universitas Indonesia.
Trial summary
The goal of this clinical study is to find out whether using ketoconazole 2% shampoo for seven days works better than using it for three days in treating pityriasis versicolor. The study will also evaluate the safety of both treatment durations. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy 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
- 76 participants
- Where
- No sites listed yet
- Study dates
- Feb 2026to Jun 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Male and female patients aged 12 years or older
- Patients with pityriasis versicolor confirmed mycologically by the presence of short hyphae and round spores on direct microscopic examination using potassium hydroxide (KOH) preparation and Parker Blue-Black® ink
- Patients who are willing to participate in the study and provide written informed consent after receiving adequate explanation of the study; informed assent is obtained for participants younger than 18 years
- Participants younger than 18 years who have written permission from a parent or legal guardian
Who cannot join
- Patients in an immobilized condition
- Patients with pityriasis versicolor lesions limited exclusively to the face, without involvement of other body areas
- History of hypersensitivity to ketoconazole
- Use of systemic antifungal agents or systemic corticosteroids within one month prior to study enrollment
- Use of topical antifungal agents or topical corticosteroids within two weeks prior to study enrollment
- Patients with severe immunosuppression
- Pregnant or breastfeeding women
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Mycological Efficacy and Safety of Ketoconazole 2% Shampoo With a Seven-Day Versus Three-Day Treatment Duration in Pityriasis Versicolor: A Double-Blind Randomized Clinical Trial
The goal of this clinical study is to find out whether using ketoconazole 2% shampoo for seven days works better than using it for three days in treating pityriasis versicolor. The study will also evaluate the safety of both treatment durations.
The main questions this study aims to answer are:
- Does treatment with ketoconazole 2% shampoo for seven days result in better mycological efficacy compared with three days of treatment in patients with pityriasis versicolor?
- Does treatment with ketoconazole 2% shampoo for seven days lead to better clinical improvement compared with three days of treatment?
- Are there differences in side effects between the seven-day and three-day ketoconazole 2% shampoo treatment regimens?
- Are there differences in dermoscopic features of pityriasis versicolor before and after treatment with ketoconazole 2% shampoo when used for seven days compared with three days?
Read the detailed description
This study is a double-blind randomized clinical trial designed to compare the effectiveness and safety of two different treatment durations of ketoconazole 2% shampoo in patients with pityriasis versicolor, a common superficial fungal infection caused by Malassezia species, particularly prevalent in tropical climates.
The study is conducted in outpatient dermatology clinics in Indonesia, where high temperature and humidity may contribute to persistent or suboptimal treatment responses with standard short-course topical therapy. Current clinical practice commonly recommends a three-day regimen of ketoconazole 2% shampoo; however, longer exposure may be necessary to achieve adequate antifungal activity under tropical conditions. This trial evaluates whether extending treatment to seven days provides superior therapeutic benefit while maintaining an acceptable safety profile.
Eligible participants with a confirmed diagnosis of pityriasis versicolor are randomly assigned to receive ketoconazole 2% shampoo for either three consecutive days or seven consecutive days. Randomization is performed using a concealed allocation sequence. Both participants and investigators are blinded to treatment allocation. The shampoo formulation, packaging, and labeling are identical in both groups to maintain blinding throughout the study.
Participants are instructed to apply the shampoo to affected areas or the entire body, as indicated, once daily according to the assigned regimen. The shampoo is left on the skin for a standardized duration before rinsing. No additional antifungal treatments are permitted during the study period.
Clinical and mycological evaluations are performed at baseline and during follow-up visits. Mycological assessment is conducted using direct microscopic examination of skin scrapings. Clinical evaluation includes physical examination of skin lesions and documentation of treatment response. Dermoscopic examination is performed as supportive data to assess morphological changes before and after therapy.
Safety monitoring is conducted throughout the study. Participants are instructed to report any adverse skin reactions, including irritation, burning sensation, pruritus, or signs suggestive of contact dermatitis. All adverse events are recorded and managed according to predefined safety procedures.
- Conditions
- Pityriasis Versicolor
- Being tested
- Ketoconazole 2% Shampoo, Placebo Shampoo
- Keywords
- Pityriasis Versicolor, Ketoconazole, Mycological Cure
- Medical subject headings
- Tinea Versicolor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketoconazole 2% ShampooDrug
Ketoconazole 2% shampoo is a topical antifungal formulation used for the treatment of pityriasis versicolor. It exerts its antifungal effect by inhibiting ergosterol synthesis in Malassezia species.
Placebo ShampooDrug
Placebo shampoo is a vehicle formulation identical in appearance, texture, and odor to ketoconazole shampoo but without the active antifungal ingredient. It is used to maintain blinding during the study period.
| Study group | Role | What they receive |
|---|---|---|
| Ketoconazole 2% Shampoo - 7-Day Regimen | Experimental | Participants receive ketoconazole 2% shampoo, applied once daily to affected skin areas or the whole body, as instructed. The shampoo is left on the skin for 5 minutes before rinsing. Treatment is administered for seven consecutive days. Receives: Drug: Ketoconazole 2% Shampoo |
| Ketoconazole 2% Shampoo - 3-Day Regimen with Placebo | Active comparator | Participants receive ketoconazole 2% shampoo, applied once daily for three consecutive days, followed by a placebo shampoo once daily for four additional days, resulting in a total treatment duration of seven days. The shampoo is left on the skin for 5 minutes before rinsing. The application method is identical in both arms. Receives: Drug: Ketoconazole 2% Shampoo; Drug: Placebo Shampoo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with negative KOH microscopy
Mycological cure is defined as a negative result on direct microscopic examination of skin scrapings using potassium hydroxide (KOH) preparation after completion of treatment.
Measured: Day 7 after initiation of treatment
Secondary outcomes (3)
Proportion of participants with resolution of fine scaling
Clinical improvement is assessed based on the resolution of fine scaling associated with pityriasis versicolor on physical examination.
Measured: Day 7 after initiation of treatment
Number of participants with treatment-related local adverse events
Adverse events include any local skin reactions such as pruritus, burning sensation, erythema, or contact dermatitis reported or observed during the treatment period.
Measured: During the 7-day treatment period
Proportion of participants with improvement in dermoscopic scaling
Improvement is defined as the reduction or absence of fine scaling on dermoscopic examination at Day 7 compared with baseline.
Measured: During the 7-day treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study startFeb 2026 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionJun 2026 (estimated)
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.
- 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
- Model description
- This study uses a parallel interventional study model. Eligible participants with pityriasis versicolor are randomly assigned to one of two treatment groups and followed concurrently throughout the study period. One group receives ketoconazole 2% shampoo once daily for seven consecutive days. The comparison group receives ketoconazole 2% shampoo once daily for three consecutive days, followed by a placebo shampoo for the remaining four days, resulting in a total treatment period of seven days in both groups. Each participant is assigned to a single treatment group and does not switch interventions during the study. Randomization is performed using a concealed allocation sequence, and both participants and investigators are blinded to group assignment. The parallel design allows direct comparison of treatment duration effects on efficacy and safety while maintaining identical treatment duration and blinding between groups.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fakultas Kedokteran Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eliza Miranda, MD, PhD, Fakultas Kedokteran Universitas Indonesia
- Investigators
- Eliza Miranda, MD, PhD, Principal investigator, Fakultas Kedokteran Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07471178
- Sponsor's protocol ID
- 25-08-1311
- Status last verified
- Jan 2026
- First submitted
- 22 Dec 2025
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared with other researchers. All data collected in this study will be used solely for the purposes of the study protocol and related publications, and will be reported only in aggregate form to protect participant confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mycological Efficacy and Safety of Ketoconazole 2% Shampoo With a Seven-Day Versus Three-Day Treatment Duration in Pityriasis Versicolor: A Double-Blind Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07471178
- Acronym / sponsor ID
- 25-08-1311
- Conditions
- Pityriasis Versicolor
- Keywords
- Pityriasis Versicolor, Ketoconazole, Mycological Cure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Fakultas Kedokteran Universitas IndonesiaUniversity, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 13 Mar 2026 (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.
The goal of this clinical study is to find out whether using ketoconazole 2% shampoo for seven days works better than using it for three days in treating pityriasis versicolor. The study will also evaluate the safety of both treatment durations.
The main questions this study aims to answer are:
- Does treatment with ketoconazole 2% shampoo for seven days result in better mycological efficacy compared with three days of treatment in patients with pityriasis versicolor?
- Does treatment with ketoconazole 2% shampoo for seven days lead to better clinical improvement compared with three days of treatment?
- Are there differences in side effects between the seven-day and three-day ketoconazole 2% shampoo treatment regimens?
- Are there differences in dermoscopic features of pityriasis versicolor before and after treatment with ketoconazole 2% shampoo when used for seven days compared with three days?
Detailed description
This study is a double-blind randomized clinical trial designed to compare the effectiveness and safety of two different treatment durations of ketoconazole 2% shampoo in patients with pityriasis versicolor, a common superficial fungal infection caused by Malassezia species, particularly prevalent in tropical climates.
The study is conducted in outpatient dermatology clinics in Indonesia, where high temperature and humidity may contribute to persistent or suboptimal treatment responses with standard short-course topical therapy. Current clinical practice commonly recommends a three-day regimen of ketoconazole 2% shampoo; however, longer exposure may be necessary to achieve adequate antifungal activity under tropical conditions. This trial evaluates whether extending treatment to seven days provides superior therapeutic benefit while maintaining an acceptable safety profile.
Eligible participants with a confirmed diagnosis of pityriasis versicolor are randomly assigned to receive ketoconazole 2% shampoo for either three consecutive days or seven consecutive days. Randomization is performed using a concealed allocation sequence. Both participants and investigators are blinded to treatment allocation. The shampoo formulation, packaging, and labeling are identical in both groups to maintain blinding throughout the study.
Participants are instructed to apply the shampoo to affected areas or the entire body, as indicated, once daily according to the assigned regimen. The shampoo is left on the skin for a standardized duration before rinsing. No additional antifungal treatments are permitted during the study period.
Clinical and mycological evaluations are performed at baseline and during follow-up visits. Mycological assessment is conducted using direct microscopic examination of skin scrapings. Clinical evaluation includes physical examination of skin lesions and documentation of treatment response. Dermoscopic examination is performed as supportive data to assess morphological changes before and after therapy.
Safety monitoring is conducted throughout the study. Participants are instructed to report any adverse skin reactions, including irritation, burning sensation, pruritus, or signs suggestive of contact dermatitis. All adverse events are recorded and managed according to predefined safety procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study uses a parallel interventional study model. Eligible participants with pityriasis versicolor are randomly assigned to one of two treatment groups and followed concurrently throughout the study period. One group receives ketoconazole 2% shampoo once daily for seven consecutive days. The comparison group receives ketoconazole 2% shampoo once daily for three consecutive days, followed by a placebo shampoo for the remaining four days, resulting in a total treatment period of seven days in both groups. Each participant is assigned to a single treatment group and does not switch interventions during the study. Randomization is performed using a concealed allocation sequence, and both participants and investigators are blinded to group assignment. The parallel design allows direct comparison of treatment duration effects on efficacy and safety while maintaining identical treatment duration and blinding between groups.
| Arm | Type | Receives |
|---|---|---|
| Ketoconazole 2% Shampoo - 7-Day Regimen | Experimental | Drug: Ketoconazole 2% ShampooParticipants receive ketoconazole 2% shampoo, applied once daily to affected skin areas or the whole body, as instructed. The shampoo is left on the skin for 5 minutes before rinsing. Treatment is administered for seven consecutive days. |
| Ketoconazole 2% Shampoo - 3-Day Regimen with Placebo | Active comparator | Drug: Ketoconazole 2% Shampoo, Drug: Placebo ShampooParticipants receive ketoconazole 2% shampoo, applied once daily for three consecutive days, followed by a placebo shampoo once daily for four additional days, resulting in a total treatment duration of seven days. The shampoo is left on the skin for 5 minutes before rinsing. The application method is identical in both arms. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female patients aged 12 years or older
- Patients with pityriasis versicolor confirmed mycologically by the presence of short hyphae and round spores on direct microscopic examination using potassium hydroxide (KOH) preparation and Parker Blue-Black® ink
- Patients who are willing to participate in the study and provide written informed consent after receiving adequate explanation of the study; informed assent is obtained for participants younger than 18 years
- Participants younger than 18 years who have written permission from a parent or legal guardian
Key exclusion criteria (7 listed)
- Patients in an immobilized condition
- Patients with pityriasis versicolor lesions limited exclusively to the face, without involvement of other body areas
- History of hypersensitivity to ketoconazole
- Use of systemic antifungal agents or systemic corticosteroids within one month prior to study enrollment
- Use of topical antifungal agents or topical corticosteroids within two weeks prior to study enrollment
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 |
|---|---|---|
| Ketoconazole 2% ShampooKetoconazole 2% shampoo is a topical antifungal formulation used for the treatment of pityriasis versicolor. It exerts its antifungal effect by inhibiting ergosterol synthesis in Malassezia species. | Drug | Ketoconazole 2% Shampoo - 3-Day Regimen with Placebo, Ketoconazole 2% Shampoo - 7-Day Regimen |
| Placebo ShampooPlacebo shampoo is a vehicle formulation identical in appearance, texture, and odor to ketoconazole shampoo but without the active antifungal ingredient. It is used to maintain blinding during the study period. | Drug | Ketoconazole 2% Shampoo - 3-Day Regimen with Placebo |
Primary outcome
Proportion of participants with negative KOH microscopy
Time frame: Day 7 after initiation of treatment
Mycological cure is defined as a negative result on direct microscopic examination of skin scrapings using potassium hydroxide (KOH) preparation after completion of treatment.
3 secondary outcomes
Proportion of participants with resolution of fine scaling
Time frame: Day 7 after initiation of treatment
Number of participants with treatment-related local adverse events
Time frame: During the 7-day treatment period
Proportion of participants with improvement in dermoscopic scaling
Time frame: During the 7-day treatment period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared with other researchers. All data collected in this study will be used solely for the purposes of the study protocol and related publications, and will be reported only in aggregate form to protect participant confidentiality.
Related trials for 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.
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Not yet recruitingPhase 1/2
Comparative Efficacy of Topical 1% Clotrimazole vs Oral Itraconazole 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
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RecruitingPhase 4
Comparison of Efficacy of Oral Fluconazole Versus Oral Itraconazole in the Treatment of Pityriasis Versicolor
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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.
Eliza Miranda, MD, PhD principal investigator
Fakultas Kedokteran Universitas Indonesia
Questions about this trial
What is this clinical trial studying?
A Phase 4 study of Pityriasis Versicolor, run by Fakultas Kedokteran Universitas 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 4 inclusion and 7 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: opening soon, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luddwi A Rizky, MD (+6281196111110, luddwiar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with negative KOH microscopy (time frame: Day 7 after initiation of treatment). 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 13 Mar 2026.