Clinical trial NCT06170333: 8% Sulphur-Aloe Vera Soap as an Adjuvant Treatment for Pityriasis Versicolor
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pityriasis Versicolor
Lead sponsor: Universitas Padjadjaran
Sponsor class: OTHER
First posted: 2023-12-14
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Male or female
2. Age 18-65 years
3. Diagnosed as PV based on clinical features, microscopic examination using 10% potassium hydroxide, and Wood's lamp

Exclusion Criteria:

1. Pregnant or lactating women
2. PV with concurrent skin conditions (dermatitis or skin lesions in form of vesicles or blister or pustules or erosions or excoriation) with body surface area \>30%
3. Use of topical antifungal and/or corticosteroid 14 days prior to study entry
4. Use of systemic antifungal and/or corticosteroid 30 days prior to study entry
5. History of allergy to shampoo or soap containing ketoconazole, sodium lauryl sulphate, sulphur, A. vera, charcoal powder, glycerin, or perfume.

Primary outcomes:
measure: Clinical assessment of pruritus
timeFrame: 28 days
measure: Scaling severity
timeFrame: 28 days
measure: Mycological cure
timeFrame: 28 days
Secondary outcomes:
measure: Wood's lamp
timeFrame: 28 days
measure: Skin hydration
timeFrame: 28 days
measure: Skin pH (potential hydrogen)
timeFrame: 28 days
Other outcomes:
Locations:
city: Bandung
country: Indonesia
facility: Hasan Sadikin General Hospital
state: Jawa Barat
Study officials:
affiliation: Faculty of Medicine, Universitas Padjadjaran, Bandung
name: Risa Miliawati Nurul Hidayah, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: