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Completed

NCT Number: NCT06170333

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hasan Sadikin General Hospital

Bandung, West Java, 40161, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 criteria

  • 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.

Treatment and study plan

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.

Other names: Blacksoap

Primary outcomes

  1. Clinical assessment of pruritus

    Time frame: 28 days

    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.

  2. Scaling severity

    Time frame: 28 days

    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.

  3. Mycological cure

    Time frame: 28 days

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

Secondary outcomes

  1. Wood's lamp

    Time frame: 28 days

    Fluorescence of skin lesions using Wood's lamp will be evaluated every visit. Positive result obtained if skin lesions showed yellow fluorescence.

  2. Skin hydration

    Time frame: 28 days

    Skin hydration will be measured using corneometer on three areas: volar, wrist, and palms. Scores are expressed in arbitary units (AU), AU <30 means very dry skin, AU between 30 -40 means dry skin, and AU >40 means normal skin

  3. Skin pH (potential hydrogen)

    Time frame: 28 days

    Skin pH will be measured using pH on three areas: volar, wrist, and palms. Normal skin pH values range from pH 4.0 to 7.0. pH level below 7 considered acidic and above 7 considered alkaline.

Sponsors and collaborators

Lead sponsor

Universitas Padjadjaran

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Dec 14, 2023
Registry last updated
Mar 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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