| CTRI Number |
CTRI/2021/12/038357 [Registered on: 01/12/2021] Trial Registered Prospectively |
| Last Modified On: |
19/09/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A Clinical Study to assess safety and effect of Hydrozid Spray for cryotherapy in skin lesions. |
|
Scientific Title of Study
|
A Post-marketing Clinical Investigation Study to assess safety and efficacy of Hydrozid Spray for cryotherapy in superficial epidermal and dermal lesions. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BCR-BMPL-01 Version 2.0 Dated 01 Sep 2021 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrAshok Alate |
| Designation |
Managing Director |
| Affiliation |
BIBAWO Medical Private Limited |
| Address |
Office C816 8th Floor
J Wing Kailash Business Park Veer Sawarkar Marg
Vikhroli West
Mumbai Maharashtra India
Mumbai
MAHARASHTRA
400079
India |
| Phone |
9820043068 |
| Fax |
|
| Email |
ashok.alate@bibawo-medical.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neeta Nargundkar |
| Designation |
Managing Director |
| Affiliation |
Biosphere Clinical Research Pvt.Ltd |
| Address |
Office No. 02 03 and 04
2nd Floor Highland Corporate Center
Kapurbawdi Junction
Thane west
Thane
MAHARASHTRA
400607
India |
| Phone |
02241006794 |
| Fax |
|
| Email |
drneeta@biospherecro.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neeta Nargundkar |
| Designation |
Managing Director |
| Affiliation |
Biosphere Clinical Research Pvt.Ltd |
| Address |
Office No. 02 03 and 04
2nd Floor Highland Corporate Center
Kapurbawdi Junction
Thane west
MAHARASHTRA
400607
India |
| Phone |
02241006794 |
| Fax |
|
| Email |
drneeta@biospherecro.com |
|
|
Source of Monetary or Material Support
|
| BIBAWO Medical Private Limited.
Office C-816, 8th Floor, J Wing, Kailash Business Park, Veer Sawarkar Marg Vikhroli-West Mumbai -400079 Maharashtra India |
|
|
Primary Sponsor
|
| Name |
BIBAWO Medical Private Limited |
| Address |
Office C-816, 8th Floor, J Wing, Kailash Business Park, Veer Sawarkar Marg Vikhroli-West Mumbai -400079 Maharashtra India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 8 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrShekhar Pradhan |
B. J Government Medical College and Sassoon General Hospital |
Department of Dermatology, Venereology, & Leprosy, B. J Government Medical College and Sassoon General Hospital, Pune- 411001, India
Pune
MAHARASHTRA |
9923184181
drsnpradhan@yahoo.co.in |
| Dr Bela Shah |
B. J. Medical College and Civil Hospital |
Department of Dermatology, B. J. Medical College and Civil Hospital, Asarwa, Ahmedabad, 380016, Gujarat, India
Ahmadabad
GUJARAT |
9898059289
shah.drbela@gmail.com |
| Dr Sonam Singh Sachan |
Brij Medical Centre Pvt. Ltd |
94-E, Near Panki Police Station, Panki, Kanpur-208020, India
Kanpur Nagar
UTTAR PRADESH |
8009238594
sonam.sachan@gmail.com |
| DrIndrashish Podder |
College of Medicine and Sagore Dutta Hospital |
Department of Dermatology,Venereology and Leprosy.College of Medicine &Sagore Dutta Hospital, 578, B. T. Road, Kamarhati, Kolkata-700058, West Bengal, India.
Kolkata
WEST BENGAL |
9007977161
ipodder88@gmail.com |
| Dr Ratnakar Kamath |
Grant Government Medical College & Sir J J Group of Hospitals |
Department of Dermatology, Venereology, & Leprosy
Grant Government Medical College & Sir J J Group of Hospitals 42-Second Floor,OPD building, JJ hospital campus, Byculla, Mumbai-400008, Maharashtra, India
Mumbai
MAHARASHTRA |
9833831951
ratnakar.kamath@gmail.com |
| DrBhangaru H |
Mysore Medical College and Research Institute and Associated Hospitals, K R Hospital |
Department of Dermatology, Mysore Medical College & Research Institute and Associated Hospitals, K R Hospital, Irwin Road, Mysore-570001, Karnataka, India.
Mysore
KARNATAKA |
9886789231
drbangaruskin@gmail.com |
| Dr Sonam Ramrakhiani |
Srishti Clinic Dermatology and Aesthetic Centre, |
Hill Spring, Commercial-1, 1st Floor, office no. 9, Vijay Garden Road, Thane-400615, Maharashtra, India
Thane
MAHARASHTRA |
9987756530
drsonam@srishtiskinclinic.in |
| Dr Shivani Mishra |
Vighnaharta Multispeaciality Hospital |
2nd Floor, APMC compound, Pachora Central, Pachora, Jalgaon-424201, Maharashtra, India
Jalgaon
MAHARASHTRA |
8697543955
gaurishiva9@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 8 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee B.J. Medical College And Civil Hospital Ahmedabad |
Submittted/Under Review |
| Institutional Ethics Committee Mysore Medical College & Research Institute and Associated Hospitals |
Approved |
| Institutional Ethics Committee of B.J. Government Medical College and Sassoon General Hospital |
Submittted/Under Review |
| Institutional Ethics Committee, Brij Medical Centre Pvt. Ltd |
Approved |
| Institutional Ethics Committee, College of Medicine &Sagore Dutta Hospital |
Approved |
| Institutional Ethics Committee, Grant Government Medical College & Sir J J Group of Hospitals, Byculla, Mumbai |
Submittted/Under Review |
| V Care Independent Ethics Committee, |
Approved |
| Vighnaharta Multispeciality Hospital Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L989||Disorder of the skin and subcutaneous tissue, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hydrozid Spray |
Hydrozid is applied to a lesion directly from the canister. Hydrozid should be applied from a distance of 2 to 3 cm and for 2 to 6 seconds, depending upon the location of the lesion Several repeated freeze-thaw cycles are recommended as in a single treatment.The total duration of application to a lesion must be kept within 36 seconds.If repeat treatment is needed treatments will be repeated at Day 14 and Day 30 |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or female patientsof age between 18 to 65 years both inclusive.
2. Patient has atleast one or more epidermal or dermal skin lesions (e.g., Verruca plantaris, Verruca vulgaris, Verruca plana, Keratosis seborrhoica, Lentigo (facial), Lentigo (non-facial), Acrochordon (skin tag),), Keratosis actinica (facial), Keratosis actinica (non-facial) Molluscum contagiosum )lesions of diameter bêtween ≥ 5 mm and ≤ 10 mm in an area suitable for treatment.
3. Patient is willing to have digital photographs taken of the treatment area and agrees to use ofphotographs for presentation, educational, or marketing purposes.
4. Patients who are willing to sign informed consent for participation in the study and willing to adhere to all protocol procedures. |
|
| ExclusionCriteria |
| Details |
1. Physician prescribed medical or surgical treatment, or use of over-the-counter products to alter skin colour, in the area of intended treatment in the previous 1 month (e.g., hydroquinone, corticosteroids, laser surgery)
2. Artificial tanning in the area of intended treatment within 1 month (e.g., spray, lotion, tanning bed) or intention to use artificial tanning within the follow-up period
3. Open wounds, cuts and delicate or eczematous skin,Scars or tattoos in the location of the treatment sites
4. History of melanoma.
5. Known history of illness or adverse reaction to cold insult (e.g..cryoglobulinaemia, Raynaud’s disease, cold urticaria, blood dyscrasias, or uncertain diagnosis).
6. Patients who have impaired healing eg due to diabetes, vascular disease, vitamin A deficiency, hyperthyroidism and hypothyroidism.
7. Patients who took immunosuppressant drugs such as oral corticosteroids within the past three months.
8. Patients who have autoimmune diseases, eg SLE, dermatomyositis, scleroderma and other diseases.
9. Patient has a history of sensitivity to any of the ingredients in the study medications.
10. Patients who cannot tolerate cryotherapy for their own reasons.
11. Patient has any current skin disease (e.g., Psoriasis, atopic dermatitis, eczema, sun damage), or condition (e.g., sunburn, excessive hair, open wounds) that, in the opinion of the investigator,might put the Patient at undue risk by study participation or interfere with the study conduct or
evaluations.
12. Inability or unwillingness to comply with the study requirements.
13. Female Patients who are pregnant or lactating or planning to become pregnant during the study period. Females who are not ready to use acceptable contraceptive methods during the course of study.
14. History of alcohol abuse and smoking.
15. Current enrollment in a clinical study of any other unapproved investigational drug or device within 30 days prior to signing informed consent. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.The incidence of adverse events (AEs) and severe adverse events (SAEs), considered as related to the study treatment.
2.Assessment of local skin reactions (LSRs)
3.Pain assessment by VAS scale just after therapy, 2 hrs, 4 hrs, 8 hrs and 24hrs after treatment.
4.Incidence rate of pigmentation and scarring following study treatment as assessed by Vancouver Scar Scale. |
1.60±2 Days
2.60±2 Days
3.24 Hours
4.60±2 Days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Percentage of patients with total disappearance of skin lesions at the end of study visit |
60±2 Days |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
06/12/2021 |
| Date of Study Completion (India) |
12/08/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study will be conducted in patients diagnosed with superficial epidermal and dermal lesions. Patients will be assessed for safety and efficacy at day 7, day 14, day 30(±2) days and 60(±2) after the cryotherapy.
The primary outcome will evaluate the incidence of adverse events related to study treatment and Assessment of local skin reactions (LSRs), pain assessment by VAS scale just after therapy, 2 hrs, 4 hrs, 8 hrs and on 24hrs after treatment and incidence rate of pigmentation and scarring following study treatment
The secondary outcome evaluates Percentage of patients with total disappearance of skin lesions at end of study visit. |