| CTRI Number |
CTRI/2024/07/071678 [Registered on: 31/07/2024] Trial Registered Prospectively |
| Last Modified On: |
11/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
In patients of a fungal skin problem called superficial dermatophytosis which is better among Itraconazole and Itraconazole with Isotretnoin? |
|
Scientific Title of Study
|
Safety and efficacy of oral itraconazole versus oral itraconazole
with isotretinoin in chronic and recurrent superficial dermatophytosis A randomized
trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Usha Chhillar |
| Designation |
Professor and Head |
| Affiliation |
BPS Govt. Medical College for Women |
| Address |
Department of Dermatology, Venereology and Leprology, BPS GMC (W), Khanpur Kalan
Sonipat
HARYANA
131305
India |
| Phone |
8607102771 |
| Fax |
|
| Email |
ushachillar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nidhi |
| Designation |
Senior Resident |
| Affiliation |
BPS GMC (W), Khanpur Kalan |
| Address |
Department of Dermatology, Venereology and Leprology, BPS GMC (W), Khanpur Kalan
Sonipat
HARYANA
131305
India |
| Phone |
9953000599 |
| Fax |
|
| Email |
nidhiyadav88@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Usha Chhillar |
| Designation |
Professor and Head |
| Affiliation |
BPS GMC (W), Khanpur Kalan |
| Address |
Department of Dermatology, Venereology and Leprology, BPS GMC (W), Khanpur Kalan
Sonipat
HARYANA
131305
India |
| Phone |
8607102771 |
| Fax |
|
| Email |
ushachillar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bhagat Phool Singh Govt. Medical College For Women, Khanpur Kalan,
Sonipat. Haryana 131305 |
|
|
Primary Sponsor
|
| Name |
Bhagat Phool Singh Govt. Medical College |
| Address |
Khanpur Kalan, Sonipat, Haryana,
131305, India |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Usha Chhillar |
BPS Govt. Medical College For Women |
Department of Dermatology, BPS GMC For Women, Khanpur Kalan, Sonipat
Sonipat
HARYANA |
8607102771
ushachillar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Combination of Tablet Itraconazole 100mg and Tablet Isotretinoin 20mg |
Intervention group will have 35 patients and receive tablet Itraconazole 100mg two times a day in combination with Tablet Isotretinoin 20mg one time in a day orally for 4 weeks. |
| Comparator Agent |
Tablet Itraconazole 100 mg |
Comparator group will
have 35 patients and
receive tablet Itraconazole 100mg two times a day orally for 4 weeks.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All adult patients in the age group of 18 to 60 years who are clinically
diagnosed with tinea corporis and cruris with more than 20% BSA and duration of infection is
more than 6 months with KOH positive preparation attending the dermatology Out Patient
Department of BPS GMC(W) Khanpur Kalan, Sonepat. |
|
| ExclusionCriteria |
| Details |
1) Patients with tinea capitis and onychomycosis.
2) Patients with tinea for less than 6 months or limited tinea involving less than 20% of body
surface area.
3) Any patient who took itraconazole for tinea in last one year.
4) Patients with liver diseases, renal diseases and ischaemic heart diseases.
5) Patients with hyperlipidaemia.
6) Patients currently on immunosuppressive and corticosteroid therapy.
7) Pregnant and lactating women and females of reproductive age who cannot or refused to take
contraceptive pills |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical assessment score, Global assessment index |
Baseline, 2 & 4weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| KOH examination, CBC, LFT, lipid profile, urine pregnancy test |
Baseline, 2 & 4weeks |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
06/09/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Dermatophytosis is a superficial cutaneous fungal infection of the keratinized tissues of skin, hair and nails. These infections are very common in India where hot and humid climate in association with poor hygienic conditions play an important role in the growth of these fungi. In the past few years, the chronicity, severity, clinical presentation, relapse rates and resistance to treatment patterns have significantly altered in India. Various factors such as host, agent, pharmacologic or environmental may be responsible for these alterations. Chronic dermatophytosis is defined as illness that lasts for more than 6 months to 1 year, with or without recurrence, irrespective of the treatment. Recurrent dermatophytosis applies to the re-occurrence of the fungal infection within a few weeks of completion of treatment. Antifungal drugs like itraconazole, griseofulvin, terbinafine are no longer giving satisfactory results. Such infections are a cause of significant distress to patients socially, financially, and emotionally. In few studies combination of itraconazole and isotretinoin was successfully treated chronic dermatophytosis. It was proposed that retinoids cause desquamation and decrease the fungal colonies from stratum corneum. However there is paucity of literature comparing efficacy of itraconazole versus isotretinoin with itraconazole. In this study, we will evaluate comparative efficacy and safety of oral itraconazole versus oral itraconazole with isotretinoin in chronic and recurrent dermatophytosis. |