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

NCT06170333 | Completed Phase 4 DMC

• 1 other identifier: DV-202309.02
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Pityriasis Versicolor

Outcome Measures

Primary Outcomes (3)

• Clinical assessment of pruritus

  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.

  28 days

• Scaling severity

  Patients will be evaluated for scaling severity according to the following scale: 0 = no scaling; 1 = mild distribution of scaling; 2 = moderate distribution of scaling; 3 = severe, extensive distribution of scaling.

  28 days

• Mycological cure

  Evaluation of mycological cure examined by microscopic examination using 10% potassium hydroxide. A cellophane tape will be used for taking scale lesions.

  28 days

Secondary Outcomes (3)

• Wood's lamp

  28 days

• Skin hydration

  28 days

• Skin pH (potential hydrogen)

  28 days

Study Arms (2)

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

EXPERIMENTAL

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

Drug: 8% sulphur and A. vera soap

Bland soap and ketoconazole 2% shampoo

ACTIVE COMPARATOR

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.

Drug: 8% sulphur and A. vera soap

Interventions

8% sulphur and A. vera soap DRUG

Patients in experimental arms will receive the combination of 8% sulphur and A. vera soap for four weeks along with 2% ketoconazole shampoo for a week.

Also known as: Blacksoap

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pregnant or lactating women
• 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%
• 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.

Sponsors & Collaborators

• Universitas Padjadjaran: lead

Study Sites (1)

Hasan Sadikin General Hospital

Bandung, West Java, 40161, Indonesia

Location

MeSH Terms

Conditions

Tinea Versicolor

Interventions

Sulfur

Condition Hierarchy (Ancestors)

Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals

Study Officials

• Risa Miliawati Nurul Hidayah, MD, Ph.D

  Faculty of Medicine, Universitas Padjadjaran, Bandung

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2023
• First Posted: December 14, 2023
• Study Start: August 25, 2023
• Primary Completion: December 31, 2023
• Study Completion: January 31, 2024
• Last Updated: March 26, 2024

Record last verified: 2024-03

Locations

ID (1)