| CTRI Number |
CTRI/2023/04/051390 [Registered on: 06/04/2023] Trial Registered Prospectively |
| Last Modified On: |
04/12/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study to evaluate the efficacy and safety of minocycline hydrochloride topical gel in skin condition (pimples). |
|
Scientific Title of Study
|
Prospective, open label, multicentre, single arm, Phase IV study for evaluation of safety, tolerability and efficacy of minocycline hydrochloride topical gel 4% in Indian patients with moderate to severe acne vulgaris. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| GPL/CT/2021/001/IV Version 2.0 dated 29-Jun-2021 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sumit Bhushan |
| Designation |
Senior Manager- Global Medical Affairs (IF) |
| Affiliation |
GLENMARK PHARMACEUTICALS LIMITED |
| Address |
Glenmark Corporate Enclave, B D Sawant Marg, Andheri (E), Mumbai
Mumbai (Suburban)
MAHARASHTRA
400099
India |
| Phone |
|
| Fax |
|
| Email |
Sumit.Bhushan@glenmarkpharma.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sumit Bhushan |
| Designation |
Senior Manager- Global Medical Affairs (IF) |
| Affiliation |
GLENMARK PHARMACEUTICALS LIMITED |
| Address |
Glenmark Corporate Enclave, B D Sawant Marg, Andheri (E), Mumbai
MAHARASHTRA
400099
India |
| Phone |
|
| Fax |
|
| Email |
Sumit.Bhushan@glenmarkpharma.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sumit Bhushan |
| Designation |
Senior Manager- Global Medical Affairs (IF) |
| Affiliation |
GLENMARK PHARMACEUTICALS LIMITED |
| Address |
Glenmark Corporate Enclave, B D Sawant Marg, Andheri (E), Mumbai
MAHARASHTRA
400099
India |
| Phone |
|
| Fax |
|
| Email |
Sumit.Bhushan@glenmarkpharma.com |
|
|
Source of Monetary or Material Support
|
| GLENMARK PHARMACEUTICALS LIMITED,
Glenmark Corporate Enclave, B D Sawant Marg, Andheri (E), Mumbai 400099 |
|
|
Primary Sponsor
|
| Name |
Glenmark Pharmaceuticals Limited |
| Address |
Glenmark Corporate Enclave, B D Sawant Marg, Andheri (E), Mumbai 400099 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 8 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Swetalina Pradhan |
All India Institute of Medical Sciences |
Department of Dermatology, Phulwari sharif, Patna, Bihar 801507,India
Patna
BIHAR |
8298695501
drswetalinap11223@gmail.com |
| Dr Vijay Kumar Sonkar |
S N Medical college |
Department of Dermatology, near blood bank, Agra, UP-282003
Agra
UTTAR PRADESH |
9412561550
researchsnmc111@gmail.com |
| Dr Richa Gupta |
Aatman Hospital |
Department of Dermatology, 5, Anveshan Row House opp umiya Mata Mandir Bopal Ghuma Main Road, Bopal Ghuma Ahmedabad 380058, lndia
Ahmadabad
GUJARAT |
9879245064
Drricha08.gupta@gmail.com |
| Dr Prerna R Suryatale |
Jeevan Rekha Hospital |
Department of Dermatology, Opp Civil Hospital, Belgaum- 590002,India
Belgaum
KARNATAKA |
7766984722
dr.prernasuryatale@gmail.com |
| Dr Bangaru H |
K R Hospital |
Room No 14, Department of Dermatology, OPD Building, Irwin road, Mysore 570001,India
Mysore
KARNATAKA |
9886789231
drbangaruskin@gmail.com |
| Dr Mamta Bhura |
New Leelamani Hospital Pvt Ltd |
Ground floor, 14/116, C-1,Parade Chauraha, Civil Lines, Kanpur,UP 208001
Kanpur Nagar
UTTAR PRADESH |
9555989176
drmamtabhura7@gmail.com |
| Dr Vishalakshi Viswanath |
Rajiv Gandhi Medical College and Chhatrapati Shivaji Maharaj Hospital |
Department of dermatology, Thane Municipal Corporation, Kalwa, Thane, Maharastra 400605,India
Thane
MAHARASHTRA |
9324086679
visha1967@gmail.com |
| Dr Abhishek De |
Wizderm Speciality Skin and Hair Clinic India |
Department of Dermatology, 1st floor, 1/503, Gariahat Road, Jodhpur Park, Kolkata- 700068
Kolkata
WEST BENGAL |
9903275551
dr_abhishek_de@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 8 |
| Name of Committee |
Approval Status |
| Ethics Committee Jeevan Rekha Hospital |
Approved |
| HP Poddar Memorial Clinic and Nursing Home |
Approved |
| IEC-AIIMS-P ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
Approved |
| Institutional Clinical Ethics Committee, Rajiv Gandhi medical College and Chhatrapati Shivaji Maharaj Hospital |
Approved |
| Institutional Ethics Committee Aatman Hospital |
Approved |
| Institutional Ethics Committee Leelamani Hospital |
Approved |
| Institutional Ethics Committee Mysore Medical College and Research Institute and Associated Hospitals K R Hospital |
Approved |
| Institutional Ethics Committee S.N Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L700||Acne vulgaris, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Minocycline hydrochloride topical gel 4% |
Once daily preferably at similar time of the day at least 1 hour before bedtime for 12 Weeks |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
9.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Each patient must meet all of the following criteria to be enrolled in the study:
1. Patients aged 9 years or more, of either gender diagnosed with moderate to severe acne vulgaris defined by:
a. 20 to 50 inflammatory lesions (papules, pustules, and nodules)
b. 25 to 100 non-inflammatory lesions (open and closed comedones)
c. No more than 2 nodules on the face
d. IGA score of moderate (3) to severe (4)
2. Patients who will refrain from use of any other acne medication, medicated cleanser, excessive sun exposure for the duration of the study.
3. Patients who are willing to use effective contraceptive method for the duration of the study.
4. Patients/their parents/legal guardians/representatives willing to give consent/assent to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1. Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne), or any dermatological condition of the face or facial hair (eg, beard, sideburns, mustache) that could interfere with the clinical evaluations.
2. Severe systemic disease as assessed by the Investigator that might interfere with the conduct of the study or the interpretation of the results.
3. Sunburn on the face.
4. Female patients who are pregnant, lactating, or planning a pregnancy.
5. Patients who have a documented history or known case of any of the following:
a. Allergy to tetracycline-class antibiotics or to any ingredient in the study drug.
b. Pseudomembranous colitis or antibiotic-associated colitis.
c. Known or suspected premalignant or malignant disease (excluding successfully treated skin cancers).
6. Clinically significant hepatic impairment (ALT & AST values >3 times upper limit)/renal impairment (eGFR (<90 mL/min) and positive ANA titer.
7. Patients who have used the following medications:
Within 1 week prior to screening:
• Medicated facial cleansers on the face.
• Topical acne treatments on the face (other than those listed below).
Within 4 weeks prior to screening:
• Topical retinoid (e.g. tretinoin, tazarotene, adapalene) on the face.
• Topical antimicrobials (e.g. clindamycin, erythromycin)
• Topical anti-inflammatories and/or corticosteroids on the face, benzoyl peroxide, salicylic acid, α-hydroxy/glycolic acid
• Systemic antibiotics (Minocycline, doxycycline).
• Systemic acne treatments.
Within 12 weeks prior to screening:
• Systemic retinoid.
• Systemic corticosteroids
• Estrogens or change in oral contraceptives therapy
8. Have received an investigational therapy (including investigational drug or procedure) and vaccines including COVID-19 vaccine within 28 days of screening or plan to use one during the study
9. Refusal to participation expressed by patient or legal guardian/representative.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the local skin tolerability (erythema, dryness, hyperpigmentation, skin peeling, pruritus) of minocycline hydrochloride topical gel 4% in Indian patients with moderate to severe acne vulgaris |
up to 84 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Number of adverse events (AEs), serious adverse events (SAEs), treatment related AEs and SAEs and AEs leading to dose modification/discontinuation of treatment
2) Change from baseline in the inflammatory and non-inflammatory lesion count at week 3, 6, 9 and 12
3) IGA treatment score |
1) Upto 84 days
2) Weeks 3,6,9,12
3) Weeks 3,6,9,12 |
|
|
Target Sample Size
|
Total Sample Size="256"
Sample Size from India="256"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="256" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
20/04/2023 |
| Date of Study Completion (India) |
26/04/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This
prospective, open label, multicentre, single arm, Phase IV study is to
investigate the safety, tolerability and efficacy of minocycline hydrochloride
topical gel 4% in Indian patients with moderate to severe acne vulgaris. 256 patients will be enrolled in study across India and followed up for 12 Weeks. Safety
will be assessed for local skin tolerability on 4 point scale (0=none;
3=severe). Efficacy
evaluations (acne lesion count, investigator’s global assessment) will be
performed at baseline, week 3, 6, 9 and 12. |