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

Study Status: RECRUITING
Recruit Status: RECRUITING
Study Type: INTERVENTIONAL

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

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 Summary: 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.
Sponsor: Universitas Padjadjaran

Current Primary Outcome: 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.

Original Primary Outcome: 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.

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Universitas Padjadjaran

Dates:
Date Received: December 06, 2023
Date Started: August 25, 2023
Date Completion: January 31, 2024
Last Updated: December 06, 2023
Last Verified: December 01, 2023