| CTRI Number |
CTRI/2024/09/073543 [Registered on: 06/09/2024] Trial Registered Prospectively |
| Last Modified On: |
23/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
New ointment in the treatment for Skin Warts |
|
Scientific Title of Study
|
Safety and efficacy of a formulation of a novel triple combination paint in the management of cutaneous warts |
| 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 Boney Priya P Jose |
| Designation |
Post graduate |
| Affiliation |
Saveetha Medical College and Hospital |
| Address |
Department of Dermatology, Saveetha Medical College and Hospital,
Saveetha Nagar, Thandalam, Chennai
Chennai
TAMIL NADU
602105
India |
| Phone |
9747362688 |
| Fax |
|
| Email |
boneypriya92@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr C.R.V. Narasimhalu |
| Designation |
Post graduate |
| Affiliation |
Saveetha Medical College and Hospital |
| Address |
Department of Dermatology, Saveetha Medical College and Hospital,
Saveetha Nagar, Thandalam, Chennai
Chennai
TAMIL NADU
602105
India |
| Phone |
9445188988 |
| Fax |
|
| Email |
drnarasimhalu@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Boney Priya P Jose |
| Designation |
Post graduate |
| Affiliation |
Saveetha Medical College and Hospital |
| Address |
Department of Dermatology, Saveetha Medical College and Hospital,
Saveetha Nagar, Thandalam, Chennai
Chennai
TAMIL NADU
602105
India |
| Phone |
9747362688 |
| Fax |
|
| Email |
boneypriya92@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Dermatology, Saveetha Medical College and Hospital,
Saveetha Nagar, Thandalam, Chennai,Tamilnadu, India, 602105 |
|
|
Primary Sponsor
|
| Name |
Dr Boney Priya P Jose |
| Address |
Post graduate, Department of Dermatology, Saveetha Medical College and Hospital,
Saveetha Nagar, Thandalam, Chennai,Tamilnadu, India, 602105 |
| Type of Sponsor |
Other [Self] |
|
|
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 Boney Priya P Jose |
Saveetha Medical College and Hospital |
Room No 401, 4th Floor,
Department of Dermatology,
Saveetha Medical College and Hospital,
Saveetha Nagar, Thandalam, Chennai,Tamilnadu, India, 602105
Chennai
TAMIL NADU |
9747362688
boneypriya92@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha medical college and hospital institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B079||Viral wart, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NOT APPLICABLE. |
This study is a single-arm trial designed to evaluate the safety and efficacy of the novel triple combination paint without a comparative agent. |
| Intervention |
Topical formulation of triple combination of salicylic acid, hydrogen peroxide and thuja occidentalis |
The intervention involves the development and application of a novel topical formulation designed for the treatment of cutaneous warts. This formulation combines three active ingredients: salicylic acid (10%), hydrogen peroxide (10%), and thuja occidentalis (10%). Each component is selected for its unique properties and complementary mechanisms of action in the management of cutaneous warts.
Active Ingredients:
Salicylic Acid (10%): A keratolytic agent that facilitates the shedding of the outer layer of the skin, promoting the removal of wart tissue.
Hydrogen Peroxide (10%): An antiseptic and oxidizing agent that helps in reducing the viral load and promoting the destruction of wart tissue.
Thuja Occidentalis (10%): A plant extract known for its antiviral and immunomodulatory properties, enhancing the bodys ability to combat HPV-induced warts.
Formulation:
The triple combination is formulated into a topical paint, ensuring optimal stability, efficacy, and ease of application. The formulation process includes:
Precise measurement and mixing of each active ingredient in a controlled environment.
Utilization of appropriate solvents and stabilizers to maintain the integrity and potency of the active ingredients.
Ensuring the final product is homogeneous and can be easily applied to the affected area.
Application Protocol:
Preparation: The affected area (cutaneous wart) is cleaned and dried thoroughly before application.
Dosage: One time a day.
Route of administration: Topical: A thin layer of the triple combination paint is applied directly to the wart, ensuring complete coverage.
Frequency: The application is repeated daily at night time alone.
Duration of treatment: 4-6 weeks or until the lesion goes off.
Monitoring: Patients are advised to monitor the treated area for any adverse reactions such as redness, irritation, or allergic responses. Regular follow-up visits are scheduled to assess progress and adjust the treatment regimen if necessary.
Safety and Efficacy Monitoring:
Safety: Adverse reactions are documented, and patients are provided with instructions on how to manage any minor side effects. Severe reactions prompt immediate discontinuation of the treatment and medical evaluation.
Efficacy: The primary measure of efficacy is the complete clearance of the wart. Secondary measures include the time taken for wart clearance, recurrence rate, and patient satisfaction.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Participants aged 18 years to 60 years with clinically diagnosed cutaneous warts. |
|
| ExclusionCriteria |
| Details |
The following participants are exluded from the study:
Pregnant or lactating women
Individuals with immunodeficiency disorders
individuals having allergy to any component of the triple combination paint |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the improvement in cutaneous warts |
On day 10, day 24, every two weeks thereafter |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the complications |
On day 10, day 24, every two weeks thereafter |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
09/09/2024 |
| 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="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This research project aims to evaluate the safety and efficacy of a novel topical formulation combining hydrogen peroxide (10%), salicylic acid (10%), and thuja occidentalis (10%) for the treatment of cutaneous warts. The study will be conducted at the dermatology outpatient department of Saveetha Institute of Medical and Technical Sciences, Chennai, and will involve adult patients with clinically diagnosed cutaneous warts. The primary objective is to assess the clearance of warts using the triple combination paint. Secondary objectives include measuring the time to wart clearance, recurrence rates, patient satisfaction, incidence of adverse reactions, and improvements in quality of life. Methodology: This prospective clinical study will enroll patients aged 18 years and above who meet the inclusion criteria and consent to participate. The topical formulation will be applied daily for a duration of 6 weeks. Safety and efficacy will be monitored through regular follow-up visits at weeks 1, 2, 4, and 6, with post-treatment follow-ups at 3 and 6 months. Inclusion Criteria: Adults aged 18 and above with clinically diagnosed cutaneous warts Exclusion Criteria: Known hypersensitivity to any component of the formulation Pregnant or lactating women Immunocompromised individuals Expected Outcomes: The study aims to demonstrate that the triple combination paint is a safe and effective treatment for cutaneous warts, with high patient satisfaction and low recurrence rates. Findings from this study could lead to the development of a new, non-invasive treatment option for cutaneous warts, benefiting both patients and the broader medical community. Regular monitoring and thorough documentation of adverse reactions will ensure the safety of participants, while the efficacy of the treatment will be evaluated based on clinical assessments and patient feedback. The study’s findings could significantly advance dermatological therapeutics and improve patient outcomes in the management of cutaneous warts. |