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临床试验/CTRI/2025/03/082290
CTRI/2025/03/082290尚未招募2/3 期

ASSESSING THE EFFICACY OF 30 PERCENT SALICYLIC ACID PEEL WITH 1 PERCENT TOPICAL LULICONAZOLE FOR TREATMENT OF DERMATOPHYTOSIS A RANDOMISED CONTROL TRIAL IN CHENGALPATTU TAMilNADU INDIA

dr sivaram1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2025年3月25日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
150
试验地点
1
主要终点
mycological cure : absence of fungal hyphae on KOH mount

研究概览

简要总结

Dermatophytosis are superficial fungal infections by three species of fungi  Microsporum, Trichophyton, Epidermophyton. Diagnosis is usually based on history and clinical appearance plus direct microscopy of a potassium hydroxide(KOH) preparation. Culture or histologic examination is rarely required for diagnosis.

In India  the disease  burden of dermatophytosis  ranges from 36.6 % to 78.4 %  (Shaikh Naseem et al.,2023)

Most anti fungal drugs target ergosterol which is unique to the fungal cell wall and absent in mammalian cells. A single molecule alters target by natural selection ,Irrational use of combination of anti-fungal drugs with topical steroid usage   causes   increased in resistance for anti fungal treatments ,Finding the most effective and readily accessible approach remains crucial.

Salicylic acid is a member of group of compound known as beta hydroxy acids, It is a keratolytic agent,  Which desquamates stratum corneum along with keratinophyllic dermatophytes which resides there.

The azole group of anti fungal medication have been extensively employed for treatment of dermatophytosis, The major challenges and problem in dermatophytosis treatment will be anti fungal resistant.

The study has the potential to provide valuable insight to overcome the problem of topical antifungal resistance by replacing with 30% salicylic acid for the treatment of dermatophytosis,

Application of 30% salicylic acid in Dermatology OPD twice a week will help to overcome the patient’s non-compliance and inconsistent application of anti fungal, thus improving the adherence of patient towards treatment

Comparing the efficacy and safety of 30% salicylic acid with Topical luliconazole as an adjuvant therapy in achieving mycological and clinical cure.

Primary outcome variable

  1. Mycological cure : Absence of fungal hyphae on KOH Mount when visualise under microscope

  2. Clinical cure : Complete resolution of all the clinical symptoms (itching, scaling, erythema, no new lesions )

Secondary outcome variable

  1. Adverse effects : Measures the occurrence of any side-effects with the treatment

  2. Quality of life : Assessed by DLQI questionnaire

Patient attending dermatology OPD in Karpaga Vinayaka Institute of medical sciences and research Centre, Of either gender and above 18 years of age. Clinically diagnosed with dermatophytosis, Relevant history will be taken regarding age, sex, duration of complaints, treatment history, comorbidities and family history. Patient with KOH mount positive are enrolled in this study ,Patient were randomly allocated into two groups by chit method (simple block computerised randomisation),

Two groups- group A and group B are divided ,

Group A will be given topical luliconazole with oral itraconazole.

Group B will be given 30% salicylic acid with oral itraconazole.

Follow-up for once every two weeks for eight weeks .

30% salicylic acid will be given at week 0, week 2, week 4 , week 6 for Group B.

The KOH Mount is performed at baseline , fourth week ,eighth weeks of treatment.

Dermatology life quality index questionnaire and Total symptom score will be assessed at baseline, four and eighth weeks of treatment.

Consent will be taken from the patient for using information

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • patient aged above 18 years of age patient clinically diagnosed with dermatophytosis patient mycologically confirmed tinea by KOH mount.

排除标准

  • pregnant , lactation women individuals with extensive tinea corporis involving a large area of the body ( more than 10% of body surface area.

结局指标

主要结局

mycological cure : absence of fungal hyphae on KOH mount

时间窗: it is assessed at baseline, week 4 , week 8

clinical cure : complete resolution of all the clinical symptoms ( itching , scaling , erythema )

时间窗: it is assessed at baseline, week 4 , week 8

次要结局

  • clinical cure : complete resolution of all the clinical symptoms ( itching , scaling , erythema )(adverse effects : measure the ocuurance of any side effects)

研究者

发起方
dr sivaram
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

sivaram M

karpaga vinayaga institute of medical sciences and research institute

研究点 (1)

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