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

NCT06307223 | Completed Phase 4

• 1 other identifier: 20240301
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Malassezia Folliculitis

Keywords

malassezia folliculitis; supramolecular salicylic acid; zinc pyrithione; clinical research; treatment

Outcome Measures

Primary Outcomes (3)

• lesion counts

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

  From enrollment to week 12

• The reduction rate of lesion counts

  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

  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 Outcomes (1)

• Clinical symptoms scores

  From enrollment to week 12

Study Arms (1)

30% supramolecular salicylic acid combined with supramolecular active zinc treatment group

EXPERIMENTAL

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; Drug: supramolecular active zinc

Interventions

30% supramolecular salicylic acid DRUG

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

30% supramolecular salicylic acid combined with supramolecular active zinc treatment group

supramolecular active zinc DRUG

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

30% supramolecular salicylic acid combined with supramolecular active zinc treatment group

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital of Xi'an Jiaotong University: lead

Study Sites (1)

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710000, China

Location

Related Publications (8)

• Vlachos C, Henning MAS, Gaitanis G, Faergemann J, Saunte DM. Critical synthesis of available data in Malassezia folliculitis and a systematic review of treatments. J Eur Acad Dermatol Venereol. 2020 Aug;34(8):1672-1683. doi: 10.1111/jdv.16253. Epub 2020 Apr 30.

  PMID: 32012377 RESULT

• Roques C, Brousse S, Panizzutti C. In vitro antifungal efficacy of ciclopirox olamine alone and associated with zinc pyrithione compared to ketoconazole against Malassezia globosa and Malassezia restricta reference strains. Mycopathologia. 2006 Dec;162(6):395-400. doi: 10.1007/s11046-006-0075-0.

  PMID: 17146583 RESULT

• Berger RS, Fu JL, Smiles KA, Turner CB, Schnell BM, Werchowski KM, Lammers KM. The effects of minoxidil, 1% pyrithione zinc and a combination of both on hair density: a randomized controlled trial. Br J Dermatol. 2003 Aug;149(2):354-62. doi: 10.1046/j.1365-2133.2003.05435.x.

  PMID: 12932243 RESULT

• Park M, Cho YJ, Lee YW, Jung WH. Understanding the Mechanism of Action of the Anti-Dandruff Agent Zinc Pyrithione against Malassezia restricta. Sci Rep. 2018 Aug 14;8(1):12086. doi: 10.1038/s41598-018-30588-2.

  PMID: 30108245 RESULT

• Magerusan SE, Hancu G, Rusu A. A Comprehensive Bibliographic Review Concerning the Efficacy of Organic Acids for Chemical Peels Treating Acne Vulgaris. Molecules. 2023 Oct 22;28(20):7219. doi: 10.3390/molecules28207219.

  PMID: 37894698 RESULT

• Henning MAS, Hay R, Rodriguez-Cerdeira C, Szepietowski JC, Piraccini BM, Ferreiros MP, Arabatzis M, Sergeev A, Nenoff P, Kotrekhova L, Nowicki RJ, Faergemann J, Padovese V, Prohic A, Skerlev M, Schmid-Grendelmeier P, Sigurgeirsson B, Gaitanis G, Lecerf P, Saunte DML. Position statement: Recommendations on the diagnosis and treatment of Malassezia folliculitis. J Eur Acad Dermatol Venereol. 2023 Jul;37(7):1268-1275. doi: 10.1111/jdv.18982. Epub 2023 Mar 13.

  PMID: 36912427 RESULT

• Theelen B, Cafarchia C, Gaitanis G, Bassukas ID, Boekhout T, Dawson TL Jr. Malassezia ecology, pathophysiology, and treatment. Med Mycol. 2018 Apr 1;56(suppl_1):S10-S25. doi: 10.1093/mmy/myx134.

  PMID: 29538738 RESULT

• Liang J, Chen Y, Yang M, Liu H, Liu Y, He S, Wang Z, Zeng W. Efficacy and safety of tranilast combined with minocycline in the treatment of moderate-to-severe rosacea: a prospective, randomized controlled study. J Dermatolog Treat. 2026 Dec;37(1):2597711. doi: 10.1080/09546634.2025.2597711. Epub 2025 Dec 22.

  PMID: 41424372 DERIVED

Study Officials

• Weihui Zeng

  Second Affiliated Hospital of Xi'an Jiaotong University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 12, 2024
• Study Start: June 7, 2022
• Primary Completion: September 20, 2023
• Study Completion: September 20, 2023
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)