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

Phase

Condition

Sunspot Fungus (Tinea Versicolor)

Yeast Infections

Treatment

8% sulphur and A. vera soap

Clinical Study ID

NCT06170333

DV-202309.02

Ages 18-65
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

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

Study Design

8% sulphur and A. vera soap

August 25, 2023

January 31, 2024

Study 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.

Connect with a study center

Hasan Sadikin General Hospital
Bandung, Jawa Barat 40161
Indonesia
Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.