CTRI/2024/10/075991 [Registered on: 28/10/2024] Trial Registered Prospectively
Last Modified On:
28/07/2025
Post Graduate Thesis
No
Type of Trial
BA/BE
Type of Study
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
To determine effifacy and safety of generic Permethrin Cream, 5% compared with Permethrin Cream, 5% in in Subjects with scabies
Scientific Title of Study
A Randomized, Double-Blind, Multi-Center, Parallel Study to Evaluate the Bioequivalence
using Clinical Endpoint of Permethrin Cream, 5 percentage
of KLM Laboratories Pvt. Ltd., India to
Permethrin Cream, 5 percentage
of Padagis Israel Pharmaceuticals Ltd in Subjects with scabies.
Trial Acronym
nil
Secondary IDs if Any
Secondary ID
Identifier
G7SYN/P-002/2024, Version 01, dated 12-01-24
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr D Sathish Kumar
Designation
Managing Director
Affiliation
G7 Synergon Private Limited
Address
G7 Synergon Private Limited
No,537, 5th main, 9th Cross
Tata Nagar, Sahakaranagar Post
Bangalore - 560092
Karnataka, India.
Bangalore KARNATAKA 560092 India
Phone
9677014651
Fax
Email
sathishkumar@g7synergon.in
Details of Contact Person Scientific Query
Name
Dr D Sathish Kumar
Designation
Managing Director
Affiliation
G7 Synergon Private Limited
Address
G7 Synergon Private Limited
No,537, 5th main, 9th Cross
Tata Nagar, Sahakaranagar Post
Bangalore - 560092
Karnataka, India.
KARNATAKA 560092 India
Phone
9677014651
Fax
Email
sathishkumar@g7synergon.in
Details of Contact Person Public Query
Name
Dr D Sathish Kumar
Designation
Managing Director
Affiliation
G7 Synergon Private Limited
Address
G7 Synergon Private Limited
No,537, 5th main, 9th Cross
Tata Nagar, Sahakaranagar Post
Bangalore - 560092
Karnataka, India.
KARNATAKA 560092 India
Phone
9677014651
Fax
Email
sathishkumar@g7synergon.in
Source of Monetary or Material Support
KLM Laboratories Pvt.Ltd.
Primary Sponsor
Name
KLM Laboratories Pvt.Ltd.
Address
KLM Laboratories Pvt. Ltd.
1004, Hubtown Viva,
Western Express High Way,
Jogeshwari (E), Mumbai,
Maharashtra 400060, India.
Department Of Dermatology ,PI OPD No -02 on ground floor
Limited, Memco Cross Road, Naroda
Road, Ahmedabad Gujarat - 382345, India Ahmadabad GUJARAT
8866770916
drkhushbuprajapati.research@gmail.com
Dr Neha Sharma
Divine Multispecialiy Hospital
Department of Dermatology , PI OPD on 2nd and 3rd Floor, Shikshapatri Sky Court, Near Swagat Flamingo, Sargasan,Gandhinagar Gujarat -382421, India Gandhinagar GUJARAT
9766014730
ns140786@gmail.com
Dr Patil Sharmila Pandharinath
Dr. D. Y. Patil Medical College Hospital and Research Centre
Dr. D. Y. Patil Medical College
Hospital and Research Centre,Department Of Dermatology OPD NO-61, 62, First Floor,
Sector-5, Nerul, Navi Mumbai,
Maharashtra - 400706 Mumbai MAHARASHTRA
8850635503
drsharmilapatil@gmail.com
Dr Chetan Kakadiya
GB Vaghani Multispeciality hospital
OPD No- 2, First Floor, Opp. Maharana pratab Udhayan (Chopati) Varachha Main Road, Varacchha Road, Surat-395006 Surat GUJARAT
9925714269
gbvaghanicr@gmail.com
Dr Italiya Vivekbhai Nathabhai
Global Hospital
Department of Dermatology PI OPD No- 405 ,fourth floor, Beside Navjivan. Sarthana Jakatnaka ,Surat Gujarat - 39500, India
Surat GUJARAT
9016961154
globalhospitalcr@gmail.com
Dr Roshnibahen Abdulbhai Vahora
GMERS Medical College
Department of Dermatology , OPD No- 205, Second Floor, Dept of Skin and V.D, Gotri, Vadodara Gujarat - 390021 Vadodara GUJARAT
9825605918
dr.roshnivahora@gmail.com
Dr Hiren Suthar
Harmony Hospial
OPD No 02, Third Floor 301, Puskar Icon, Above croma Nr. Shukan Cross Road, Nikol- Naroda Rd, Ahmedabad, Gujarat-38230 Ahmadabad GUJARAT
9974426544
drhirensuthar.researcher@gmail.com
Dr Dhruv Patel
Namostute hospital
Room No 108, First Floor, plot No-1285,Sector 6-D,GH-3 Circle, opposite Civil Hospital, Gandinagar-382006, Gujarat,India Gandhinagar GUJARAT
8347475738
drdhruvpatel.cr@gmail.com
Dr Saurabh Dineshchandra Kapadia
Pagarav Hospital
Department Of Dermatology , OPD No. 07, Basement Floor, Plot No. 512/1, Near G-6 Circle, Opposite SBI, Gandhinagar Gujarat - 382023, India Gandhinagar GUJARAT
9824261031
drsaurabhkapadia@yahoo.com
Dr Makwana Dhwaniben Ranchhodbhai
Parth Hospital
Department Of Dermatology OPD No- 1407, Fourth Floor E405/4, 407-411 Galaxy Arcade, near Galaxy Cinema, Naroda, Gujrat-382330, India Ahmadabad GUJARAT
9662133253
dhwanimakwanacr722@gmail.com
Dr Patel Dharaben Dhanjibha
Prajna Healthcare
205-208/ OPD 2nd Floor, Aagam Avenue, Near Adani CNG Pump, Sabarmati,
Ahmedabad Gujarat - 380005, India Ahmadabad GUJARAT
9427318224
ddpatel.1411@gmail.com
Dr Rashmi Singh
Shubham Sudbhawana Superspeciality
Department of Dermatology, B31/80, 23B- PI OPD on 1st Floor, Bhogabeer, Lanka Varanasi- 221005, Uttar Pradesh, India Varanasi UTTAR PRADESH
Institutional Ethics CommitteeD Y Patil Medical College Sector
Approved
Institutional Human Ethics Committee GMERS Medical College and Hospital
Approved
Pagarav Ethics Committee
Approved
Parth Hospital Ethics Committee
Approved
Riddhi Medical Nursing Home IEC
Approved
Shubham Sudbhawana Super. Hosp. Ethics Committee
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: B86||Scabies,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
Permethrin Cream, 5% (Padagis Israel Pharmaceuticals Ltd.)
Single application, Topical cream. A thin layer of cream to apply in all over skin from your neck down to toes (including the soles of feet).
Intervention
Permethrin Cream, 5% of KLM Laboratories Pvt.
Single application,
Topical cream. A thin layer of cream to apply in all over skin from your neck down to toes (including the soles of feet). 15 gm for children and 30 gm
for adults.
Inclusion Criteria
Age From
2.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
1.Male or non-pregnant, non-lactating female, at least 2 years of age or older.
2. Subject with clinical findings of scabies burrows such as excoriations and inflammatory papules, erythematous papules, etc..
3. Subject with Parasitological confirmation OR positive identification for scabies mites, eggs, or mite fecal matter by microscopic examination of a skin scraping.
4. Subject and,or parent,guardian agree that the subject shall not use any other form of scabies treatment during the duration of the study.
5. Subject OR Subject guardian willing to make every effort to immediately disinfect clothes, towels, and linens and all potentially infected household items upon diagnosis of infestation to prevent reinfestation.
6. All household members with prolonged physical contact with the subject is willing to attend baseline visit and receive allotted treatment by the Investigator in order to prevent reinfestation of the subject enrolled
7. Symptom score of 2 or 3 on a 4 point rating scale of 0-3 for nocturnal itching OR pruritus.
8. Ability to apply or have study product applied as directed to self. If Subject is a child, then parent OR guardian shall apply study product to him OR her.
9. Willing to provide written informed consent or assent, as applicable. For subjects who are considered minors i.e more than 18 completed years the parent or legal guardian shall sign the consent form and the child shall be required to sign a subject assent form, as appropriate.
10. Subject and or parent or guardian shall be willing and able to understand and comply with the requirements of the study.
11. Female Subject of childbearing potential practicing an approved method of contraception that is stable at least 3 months prior to baseline and throughout the study. Acceptable forms of birth control include any of the following 1. hormonal birth control, which must be stable for more than 3 months prior to baseline 2. abstinence subject must use condom plus spermicide if becomes sexually active 3 double barrier method, such as condom plus spermicide and have a negative Urine Pregnancy Test at the time of screening or female subjects of non-childbearing potential.
12. Male Subject must use accepted methods of birth control or must agree to practice abstinence from study entry until the application of Investigational Product.
ExclusionCriteria
Details
1. Female subjects who are pregnant, lactating, or planning to become pregnant during the study.
2. Skin conditions that could make it difficult to evaluate the extent of an infestation or would present a problem in the evaluation of response to therapy e.g. atopic dermatitis, eczema, contact dermatitis, lichen planus, papular urticaria, seborrheic dermatitis.
3. Use within 4 weeks of baseline visit 1 immunomodulators 2 systemic medications that suppress the immune system 3 topical or oral parasiticides.
4. Use within 2 weeks of baseline visit 1 topical steroids 2 topical or systemic antibiotics
5. Subject with coexisting dermatological disorder that could interfere with the diagnosis and subsequent monitoring of scabies or crusted scabies
6. Known history of irritation or sensitivity to parasiticides.
7. Known allergy or hypersensitivity to permethrin, any synthetic pyrethroid or pyrethrin, plants in the Asteraceae or Compositae family e.g. chrysanthemums, ragweed, marigolds, and daisies
8. Use of any systemic or topical acaricide or ectoparasiticide within one month before Screening.
9. Presence of severe cutaneous bacterial or fungal infections requiring therapy including systemic and topical antibiotics as determined by the Investigator.
10. Subject has signs of a systemic infection or is receiving systemic therapy for an infectious disease.
11. Subjects with an underlying immunodeficient state including prolonged treatment with corticosteroids, immunosuppressive disorders requiring therapy, severe systemic disease and history of HIV infection.
12. Subjects whose close personal contacts shall not or are not willing to comply with standard of care for Scabies management.
13. Subject who are directly employed at the study site and are associated with conduct of this study.
14. Subjects whose household members and close contacts refuse treatment
15. Subjects whose sexual contacts do not agree to restrict prolonged skin to skin contact with non-household members during the study period
16. Subjects with a household member less than 2 years of age
17. Presence of underlying skin disease that would obscure evaluation of the papules and burrows associated with scabies infection as determined by the Investigator.
18. Presence of severe cutaneous bacterial or fungal infections requiring therapy including systemic and topical antibiotics as determined by the Investigator.
19. Subjects who in the opinion of the Investigator would be non-compliant with the requirements of the study protocol.
20. Subject with clinically significant unstable medical disorders, life-threatening disease.
21. Subject who has been treated with an investigational product or investigational device within a period of 30 days prior to study enrolment.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
TimePoints
The proportion of patients clinically cured at the end of study Day 28, defined as subject either Cured or Improved.
Day 29
Secondary Outcome
Outcome
TimePoints
The proportion of patients clinically cured at the end of study Day 15, defined as subject either Cured or Improved.
Day 15
Target Sample Size
Total Sample Size="250" Sample Size from India="250" Final Enrollment numbers achieved (Total)= "0" Final Enrollment numbers achieved (India)="0"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
Permethrin is considered the drug of choice for the treatment of scabies. It is safe for use in adults and children 2 years and older. One or two applications, about a week apart may be necessary to eliminate all mites and eggs on the patient’s body.This is a Randomized, double-blind, multi-center, parallel study to evaluate the bioequivalence using clinical endpoint of Generic Product to RLD, 5% (Padagis Israel Pharmaceuticals Ltd) in subjects with scabies. Each subject shall be randomly assigned in a 1:1 ratio to treatment with the test product or reference product.