Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-26 @ 1:41 AM
Study NCT ID:
NCT06170333
Status:
COMPLETED
Last Update Posted:
2024-03-26
First Post:
2023-12-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
8% Sulphur-Aloe Vera Soap as an Adjuvant Treatment for Pityriasis Versicolor
Sponsor:
Universitas Padjadjaran
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: