Hasan Sadikin General Hospital
Bandung, West Java, 40161, Indonesia
NCT Number: NCT06170333
Pityriasis versicolor (PV) is a superficial, mild, often chronic recurring infection of the skin caused by Malassezia species which is characterized by the formation of hypopigmented, hyperpigmented and/or erythematous macules. It commonly occurs on the trunk and proximal extremities, but can also be found on the entire body. Diagnosis of PV established based on clinical features and microscopic examination with potassium hydroxide. The goals of PV treatment are: to eradicate the hyphae, disappearance of clinical signs and symptoms, to lessen recurrences, and improve patient's quality of life. Topical antifungal remains first line therapy and search for an ideal topical agent of PV continue. Various studies reported combining more than one topical agents can increase the efficacy, thus result in faster mycological cure.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 4
Bandung, West Java, 40161, Indonesia
Pityriasis versicolor commonly has extensive and irregular pattern/distribution on the body. Therefore, topical antifungal such as ketoconazole, usually given in shampoo or solution form to cover large surface area. Many studies reported adverse effects of ketoconazole shampoo including pruritus, dry skin, and allergic contact dermatitis. Non-spesific keratolytic agent, such as sulphur, used for PV work by desquamation of the entire superficial skin layer and eliminating the fungi in the process. It also could enhance the penetration of ketoconazole into the stratum corneum, increasing its potency. Aloe vera (A. vera) contains acetylated mannan that acts as humectant and increase water content in stratum corneum. The combination of sulphur and A. vera in form of a soap as adjuvant to ketoconazole shampoo potentially will result in synergistic effect, faster mycological cure, and less adverse effects. There are limited data of sulphur and A.vera soap as an adjuvant PV treatment to ketoconazole shampoo. As a result of limited data, our trial is looked forward to assess the efficacy and adverse effect of sulphur and A.vera soap as an adjuvant PV treatment to ketoconazole shampoo.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients in experimental arms will receive the combination of 8% sulphur and A. vera soap for four weeks along with 2% ketoconazole shampoo for a week.
Other names: Blacksoap
Time frame: 28 days
A visual analogue score (VAS) will be used to assess pruritus according to the following scale: 0 = no pruritus; 1-3 = mild pruritus; 4-6 = moderate pruritus; 7-10 = severe pruritus.
Time frame: 28 days
Patients will be evaluated for scaling severity according to the following scale: 0 = no scaling; 1 = mild distribution of scaling; 2 = moderate distribution of scaling; 3 = severe, extensive distribution of scaling.
Time frame: 28 days
Evaluation of mycological cure examined by microscopic examination using 10% potassium hydroxide. A cellophane tape will be used for taking scale lesions.
Time frame: 28 days
Fluorescence of skin lesions using Wood's lamp will be evaluated every visit. Positive result obtained if skin lesions showed yellow fluorescence.
Time frame: 28 days
Skin hydration will be measured using corneometer on three areas: volar, wrist, and palms. Scores are expressed in arbitary units (AU), AU <30 means very dry skin, AU between 30 -40 means dry skin, and AU >40 means normal skin
Time frame: 28 days
Skin pH will be measured using pH on three areas: volar, wrist, and palms. Normal skin pH values range from pH 4.0 to 7.0. pH level below 7 considered acidic and above 7 considered alkaline.
Universitas Padjadjaran
Other
Efficacy and Side Effects of 8% Sulphur-Aloe Vera Soap Versus Bland Soap as an Adjuvant of Ketoconazole 2% Shampoo for the Treatment of Pityriasis Versicolor: Open Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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