8% Sulphur-Aloe Vera Soap as an Adjuvant Treatment for Pityriasis Versicolor

Universitas Padjadjaran

Status and phase: Completed; Phase 4

Conditions: Pityriasis Versicolor

Treatments: Drug: 8% sulphur and A. vera soap

Study type: Interventional

Funder types: Other

Identifiers

NCT06170333

DV-202309.02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

8% sulphur and A. vera soap and ketoconazole 2% shampoo

Experimental group

Description:

Twenty-one patients will be given the combination of 8% sulphur and A. vera soap applied to the entire body surface (excluding face), left on for five minutes and then washed off. This was applied twice daily for four weeks. Along with the soap or placebo, patients will receive 2% ketoconazole shampoo, left on for five minutes and then washed off. This was applied thrice weekly for a week

Treatment:

Drug: 8% sulphur and A. vera soap

Bland soap and ketoconazole 2% shampoo

Active Comparator group

Description:

Twenty-one patients will be given bland soap applied to the entire body surface (excluding face), left on for five minutes and then washed off. This was applied twice daily for four weeks. Along with the soap or placebo, patients will receive 2% ketoconazole shampoo, left on for five minutes and then washed off. This was applied thrice weekly for a week.

Treatment:

Drug: 8% sulphur and A. vera soap