| CTRI Number |
CTRI/2021/03/032235 [Registered on: 23/03/2021] Trial Registered Prospectively |
| Last Modified On: |
30/07/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Stop Itch-Spray in fungal skin infections |
|
Scientific Title of Study
|
Open label, Single arm, Efficacy Study of Stop Itch anti-fungal powder Spray Containing Miconazole nitrate Spray of Amrutanjan Health Care Limited, in Patients either with Cutaneous Candidiasis or Dermatophytosis (Tinea/ Ring worm). |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ramesh Kannan |
| Designation |
Principal Investigator/Medical Consultant |
| Affiliation |
KI3, CRO |
| Address |
Room no:2, Medicine OPD, PM Medical Centre, Wallajapet,
Ranipet, Tamil Nadu.
Vellore
TAMIL NADU
632406
India |
| Phone |
7708925866 |
| Fax |
|
| Email |
srkguruvarshan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramesh Kannan |
| Designation |
Principal Investigator/Medical Consultant |
| Affiliation |
KI3, CRO |
| Address |
Room no:2, Medicine OPD, PM Medical Centre, Wallajapet,
Ranipet, Tamil Nadu.
TAMIL NADU
632406
India |
| Phone |
7708925866 |
| Fax |
|
| Email |
srkguruvarshan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ramesh Kannan |
| Designation |
Principal Investigator/Medical Consultant |
| Affiliation |
KI3, CRO |
| Address |
Room no:2, Medicine OPD, PM Medical Centre, Wallajapet,
Ranipet, Tamil Nadu.
TAMIL NADU
632406
India |
| Phone |
7708925866 |
| Fax |
|
| Email |
srkguruvarshan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amrutanjan Health care limited, 103, (Old No. 42-45), Luz Church Road. Mylapore, Chennai- 600 004. |
|
|
Primary Sponsor
|
| Name |
Amrutanjan Health Care Limited |
| Address |
103, (Old No. 42-45),
Luz Church Road. Mylapore,
Chennai- 600 004. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Ramesh Kannan |
PM Medical Centre |
Room no:2, Medicine OPD, PM Medical Centre, Wallajapet,
Ranipet, Tamil Nadu.
Vellore
TAMIL NADU |
7708925866
srkguruvarshan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PM Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B35||Dermatophytosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Miconazole nitrate Spray 2 %. |
To use two sprays (2%) Twice daily topically, morning and night for 4 weeks. |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects in the age group between 18 to 75 years, inclusive of both male and female subjects.
2. Subjects suffering from either candidiasis(Cutaneous Candidiasis) or Dermatophytosis (Tinea/ Ring worm) (newly diagnosed cases)
3. Patients with localized superficial fungal infection confirmed by presence of fungal hyphae in KOH (potassium hydroxide) preparation of skin scrapings from over the lesion at baseline visit
4. Availability of subject for the entire study period and willing to adhere to protocol requirements as evidenced by the written ICF duly signed by the volunteer.
5.Subject who have no evidence of life life-threatening disease during screening, medical history and whose physical examination is performed within 28 days prior to commencement of the study.
6.Atopic patients, dry skin and diabetes mellitus – subjects with either of the above problem and willing not to use any other anti-fungal drugs other than the investigational product during the study period.
7.Subjects, who are willing to avoid sun bathing, swimming, prolonged sun exposure or artificial ultra-violet rays during the course of the study.
|
|
| ExclusionCriteria |
| Details |
1.Subjects with allergies to cosmetics, moisturizers, and whitening/bleaching agents.
2.Subjects who has sunburned, chapped, or irritated skin or open wounds on test sites.
3.Subjects who are not willing to discontinue any other personal care products containing whitening/bleaching properties during study period.
4.History of skin cancer or treatment for any type of cancer within the last 2 years.
5.Subjects who are with underlying immunosuppressive state.
6.Subjects who applied any other topical agent over the lesions prior to baseline visit.
7.Pregnant women or nursing mothers.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Mycological & Clinical Cure : An assessment will be made based on the presence or absence of fungal elements in KOH preparation and mycological cure will be done at the end of the treatment and clinical improvement if evident in between (Time frame: 1-4 weeks).
2. Onset of action : (relief of itching: (30 sec, 1 min, 2 min, 5 min, 10 min, 30 min, 1 hr, 2 hr, 4 hr, 6 hr, 12 hrs and 24 hrs).
3. Onset of action: (relief from scaling & skin irritation if any) : (Time frame : day1-day 28)
|
Week 1,2,3 and 4 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Additionally, during each visit (week1, 2 and 3), subjects will be enquired regarding the symptomatic change from the initial stage and reduction in itching and scaling (using VAS scores) will be captured in the CRF.
2. Patient compliance and Quality of life pre and post treatment will be enquired.
|
Week 1,2,3 and 4 |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
Final Enrollment numbers achieved (Total)= "45"
Final Enrollment numbers achieved (India)="45" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
26/03/2021 |
| Date of Study Completion (India) |
01/07/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The subjects who fulfilled the inclusion and exclusion criteria will
be enrolled in the study. The selected subjects will receive the
test drug powder spray twice
daily for 2-4 weeks. Evaluation of the subjects will be done over 4 weeks time. An
assessment will be made based on the presence or absence of
fungal elements in KOH preparation and mycological cure will be done at the end
of the treatment and clinical improvement if evident in between. relief of itching and scaling: (30 sec, 1 min, 2 min, 5 min, 10 min, 30
min, 1 hr, 2 hr, 4 hr, 6 hr, 12 hrs and 24 hrs). subjects will be
enquired regarding the symptomatic change from the initial stage and reduction
in itching and scaling. |