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Completed

NCT Number: NCT06307223

Efficacy and Safety of 30% Supramolecular Salicylic Acid Combined With Supramolecular Active Zinc in the Treatment of Malassezia Folliculitis

Malassezia folliculitis is a common dermatological disorder. While antifungal agents generally demonstrate efficacy in application, the prevalence of recurrence and drug resistance remains a common occurrence. Supramolecular salicylic acid represents a novel class of superficial chemical peel agents, exhibiting keratolytic, anti-inflammatory, and bacteriostatic properties. Zinc pyrithione has broad spectrum antibacterial, antifungal, and anti-inflammatory effects. In the present study, investigators evaluated the clinical efficacy of topical application of supramolecular salicylic acid in combination with zinc pyrithione for the treatment and prevention of Malassezia folliculitis recurrence. All data are recorded and compared after the end of the experiment. The enrolled patients received daily application of topical supramolecular active zinc anti-dandruff lotion, in conjunction with weekly application of 30% supramolecular salicylic acid, for a duration of 8 weeks. Lesion counts, Malassezia detection, clinical symptom scores, patient satisfaction, and side effects were recorded at each visit till the week 12.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710000, China

About this study

Malassezia folliculitis is a common dermatological disorder. While antifungal agents generally demonstrate efficacy in application, the prevalence of recurrence and drug resistance remains a common occurrence. Supramolecular salicylic acid represents a novel class of superficial chemical peel agents, exhibiting keratolytic, anti-inflammatory, and bacteriostatic properties. Zinc pyrithione has broad spectrum antibacterial, antifungal, and anti-inflammatory effects. In the present study, investigators evaluated the clinical efficacy of topical application of supramolecular salicylic acid in combination with zinc pyrithione for the treatment and prevention of Malassezia folliculitis recurrence. The enrolled patients received daily application of topical supramolecular active zinc anti-dandruff lotion, in conjunction with weekly application of 30% supramolecular salicylic acid, for a duration of 8 weeks. Lesion counts, Malassezia detection, clinical symptom scores, patient satisfaction, and side effects were recorded at each visit till the week 12.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Males and nonpregnant females, aged 18-65 years old;
  • Diagnosed as Malassezia folliculitis;
  • The total lesion counts of the anterior chest or posterior dorsal skin ranged from 30 to 100 (included papules, pustules, and papulopustules).

Exclusion criteria

  • Suffering other skin diseases that may influence the result;
  • Established allergy to supramolecular salicylic acid or supramolecular active zinc;
  • Pregnant and lactating patients;
  • Patients who had received oral antifungal treatment within 4 months before the trial (or topical antifungal treatment within 2 months); had received oral antibiotics, glucocorticoids, and other folliculitis drugs within 4 weeks; or used physiotherapy for folliculitis; or treated with salicylic acid and alpha hydroxy acid; or used other topical medications for folliculitis within 2 weeks;
  • History of injection or surgery at the affected site within 2 months before the trial;
  • Immunodeficiency diseases.

Treatment and study plan

30% supramolecular salicylic acid

Drug

The patients received weekly application of 30% supramolecular salicylic acid for a duration of 8 weeks.

supramolecular active zinc

Drug

The patients received daily application of topical supramolecular active zinc anti-dandruff lotion for a duration of 8 weeks.

Primary outcomes

  1. lesion counts

    Time frame: From enrollment to week 12

    The counts of skin lesions, including papules, pustules, and papulopustules.

  2. The reduction rate of lesion counts

    Time frame: From week 1 to week 12

    The reduction rate expressed as (lesion counts at baseline - lesion counts at 8 weeks)/lesion counts at baseline×100%.

  3. Clinical efficacy

    Time frame: week 8 and week 12

    The clinical efficacy after the treatment was classified as follows: clinical cure (refers to lesion reduction rate of 100%, negative Malassezia detection), obvious improvement (refers to lesion reduction rate of 70-99%, positive or negative Malassezia detection), moderate improvement (refers to lesion reduction rate of 30-69%, positive or negative Malassezia detection), and no improvement (refers to lesion reduction rate <30%, positive Malassezia detection).

Secondary outcomes

  1. Clinical symptoms scores

    Time frame: From enrollment to week 12

    The degree of clinical symptoms, including pruritus, scale, greasiness, and erythema, was classified as 0 (none), 2 (mild), 4 (moderate), 6 (severe).

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Xi'an Jiaotong University

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 12, 2024
Registry last updated
Mar 12, 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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