Comparative efficacy of combined treatment with ketoconazole 2% cream and adapalene 0.1% gel versus ketoconazole 2% cream monotherapy in pityriasis versicolor.

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

IRCT

Registry ID

IRCT20241028063523N4

Enrollment

Registered

2024-11-27

Start date

2024-11-19

Completion date

Unknown

Last updated

2025-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pityriasis versicolor is a common yeast infection of the skin, in which flaky discolored patches appear on the chest and back. The term pityriasis is used to describe skin conditions in which the scale appears similar to bran. The multiple colors of pityriasis versicolor give rise to the second part of the name, versicolor. Pityriasis versicolor is sometimes called tinea versicolor, although the term tinea should strictly be used for dermatophyte fungus infections.. Pityriasis versicolor

Interventions

Intervention 1: Confirmed cases of Pityriasis versicolor will be divided into 2 groups. Group 1 and Group 2. (Group A) will receive a combination therapy consisting of Adapco Gel 0.1% (Adapalene) and

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Diagnosed cases of pityriasis versicolor lesions (as per operational definition) with disease involving total body surface area. Patients within the age range of 18–60 years of either sex Willing to provide informed consent.

Exclusion criteria

Exclusion criteria: Patients with known hypersensitivity/allergy to Ketoconazole or Adapalene, patients with concurrent diseases (hyperthyroidism or hyperhidrosis) and pregnant/ lactating mothers, previous treatment taken 8 weeks back will be excluded from the study.

Design outcomes

Primary

Measure	Time frame
Clinical improvement: More than 50% improvement in clinical signs of Pityriasis Versicolor. Negative fluorescence: Absence of yellow fluorescence on Wood's lamp examination of lesions. Negative KOH test: Absence of fungal elements in skin scrapings after four weeks of treatment. Timepoint: Patient will be assessed, before intervention at 2 weeks, and 4 weeks after intervention. Method of measurement: Clinical Examination: Observation of improvement in clinical signs such as scaling, pigmentation (hyperpigmentation or hypopigmentation), and lesion appearance. A more than 50% reduction in clinical signs is considered effective. Wood's Lamp Examination: Use of Wood's lamp to detect yellow fluorescence characteristic of Pityriasis Versicolor lesions. Negative fluorescence after treatment indicates efficacy. KOH Examination: Skin scrapings from lesions examined under a microscope after applying potassium hydroxide (KOH) to identify fungal elements. Absence of fungal elements after treatment confirms effectiveness. Photographic Evidence: Photographs of lesions taken before and after treatment to document changes. Demographic and Baseline Data: Collection of patient details, including age, sex, BMI, duration of the disease, and lesion size, which could influence treatment outcomes. Follow-Up Schedule: Re-evaluation at two weeks and four weeks post-treatment initiation using the above assessments.	—

Measure

Time frame

Clinical improvement: More than 50% improvement in clinical signs of Pityriasis Versicolor. Negative fluorescence: Absence of yellow fluorescence on Wood's lamp examination of lesions. Negative KOH test: Absence of fungal elements in skin scrapings after four weeks of treatment. Timepoint: Patient will be assessed, before intervention at 2 weeks, and 4 weeks after intervention. Method of measurement: Clinical Examination: Observation of improvement in clinical signs such as scaling, pigmentation (hyperpigmentation or hypopigmentation), and lesion appearance. A more than 50% reduction in clinical signs is considered effective. Wood's Lamp Examination: Use of Wood's lamp to detect yellow fluorescence characteristic of Pityriasis Versicolor lesions. Negative fluorescence after treatment indicates efficacy. KOH Examination: Skin scrapings from lesions examined under a microscope after applying potassium hydroxide (KOH) to identify fungal elements. Absence of fungal elements after treatment confirms effectiveness. Photographic Evidence: Photographs of lesions taken before and after treatment to document changes. Demographic and Baseline Data: Collection of patient details, including age, sex, BMI, duration of the disease, and lesion size, which could influence treatment outcomes. Follow-Up Schedule: Re-evaluation at two weeks and four weeks post-treatment initiation using the above assessments.

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Secondary

Measure	Time frame
Side Effects: Monitoring and documenting adverse effects related to the treatments, such as skin irritation, dryness, or allergic reactions. Timepoint: At 2 weeks and at 4 weeks. Method of measurement: Patient Self-Report: Patients will be asked to report any discomfort, such as irritation, dryness, or allergic reactions during follow-up visits. Documented using a standardized proforma. Clinical Observation: inspect the treated areas for signs of adverse reactions, such as redness, peeling, or swelling.	—

Measure

Time frame

Side Effects: Monitoring and documenting adverse effects related to the treatments, such as skin irritation, dryness, or allergic reactions. Timepoint: At 2 weeks and at 4 weeks. Method of measurement: Patient Self-Report: Patients will be asked to report any discomfort, such as irritation, dryness, or allergic reactions during follow-up visits. Documented using a standardized proforma. Clinical Observation: inspect the treated areas for signs of adverse reactions, such as redness, peeling, or swelling.

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Countries

Pakistan

Contacts

Public ContactDr Atiya Rahman

Armed forces Hospital, PNS Shifa.

Sunainap7@gmail.com+92 21 48506540

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026