NCT06307223|CompletedPhase 4
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Sponsor study identifier
interventional
21
1 country
1
Study Start
June 7, 2022
Actual (reported)Primary Completion
September 20, 2023
Actual (reported)Study Completion
September 20, 2023
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 20, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 7, 2022
Actual (reported)September 20, 2023
Actual (reported)September 20, 2023
Actual (reported)March 4, 2024
Actual (reported)March 12, 2024
Actual (reported)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
Clinical symptoms scores
From enrollment to week 12
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.
The patients received weekly application of 30% supramolecular salicylic acid for a duration of 8 weeks.
The patients received daily application of topical supramolecular active zinc anti-dandruff lotion for a duration of 8 weeks.
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710000, China
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.
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.
Weihui Zeng
Second Affiliated Hospital of Xi'an Jiaotong University
21 participants (actual enrollment reported by the registry).
First Submitted
March 4, 2024
First Posted
March 12, 2024
Study Start
June 7, 2022
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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.
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.
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.
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.
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.
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.
Primary Completion
September 20, 2023
Actual (reported)Study Completion
September 20, 2023
Actual (reported)Last Updated
March 12, 2024
Record last verified: 2024-03
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