Clinical trial NCT06307223: Efficacy and Safety of 30% Supramolecular Salicylic Acid Combined With Supramolecular Active Zinc in the Treatment of Malassezia Folliculitis
Official title: Efficacy and Safety of 30% Supramolecular Salicylic Acid Combined With Supramolecular Active Zinc in the Treatment of Malassezia Folliculitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Malassezia Folliculitis
Keywords: malassezia folliculitis
supramolecular salicylic acid
zinc pyrithione
clinical research
treatment
Lead sponsor: Second Affiliated Hospital of Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: lesion counts
timeFrame: From enrollment to week 12
measure: The reduction rate of lesion counts
timeFrame: From week 1 to week 12
measure: Clinical efficacy
timeFrame: week 8 and week 12
Secondary outcomes:
measure: Clinical symptoms scores
timeFrame: From enrollment to week 12
Other outcomes:
Locations:
city: Xi'an
country: China
facility: The Second Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
Study officials:
affiliation: Second Affiliated Hospital of Xi'an Jiaotong University
name: Weihui Zeng
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.