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

March 8, 2024 updated by: Weihui Zeng, Second Affiliated Hospital of Xi'an Jiaotong University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710000
        • The Second Affiliated Hospital of Xi'an Jiaotong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Suffering other skin diseases that may influence the result;
  2. Established allergy to supramolecular salicylic acid or supramolecular active zinc;
  3. Pregnant and lactating patients;
  4. 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;
  5. History of injection or surgery at the affected site within 2 months before the trial;
  6. Immunodeficiency diseases.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 30% supramolecular salicylic acid combined with supramolecular active zinc treatment group
The patients received weekly application of 30% supramolecular salicylic acid in conjunction with daily application of topical supramolecular active zinc anti-dandruff lotion, for a duration of 8 weeks.
Drug: 30% supramolecular salicylic acid
The patients received weekly application of 30% supramolecular salicylic acid for a duration of 8 weeks.
Drug: supramolecular active zinc
The patients received daily application of topical supramolecular active zinc anti-dandruff lotion for a duration of 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
lesion counts
Time Frame: From enrollment to week 12
The counts of skin lesions, including papules, pustules, and papulopustules.
From enrollment to week 12
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%.
From week 1 to week 12
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).
week 8 and week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
From enrollment to week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital of Xi'an Jiaotong University

Investigators

  • Study Chair: Weihui Zeng, Second Affiliated Hospital of Xi'an JiaoTong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 7, 2022

Primary Completion (Actual)

September 20, 2023

Study Completion (Actual)

September 20, 2023

Study Registration Dates

First Submitted

March 4, 2024

First Submitted That Met QC Criteria

March 8, 2024

First Posted (Actual)

March 12, 2024

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 8, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20240301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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