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CTRI Number  CTRI/2023/04/052056 [Registered on: 27/04/2023] Trial Registered Prospectively
Last Modified On: 14/06/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparative study of topical 4% minocycline gel plus oral isotretinoin vs only oral isotretinoin in Indian moderate to severe Acne vulgaris patients for safety evaluation. 
Scientific Title of Study   Prospective, randomized comparative study to evaluate safety, tolerability and efficacy of topical minocycline gel 4% plus oral isotretinoin vs oral isotretinoin only in Indian patients with moderate to severe acne vulgaris 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Abhishek De 
Designation  Professor And HOD 
Affiliation  Wizderm Specialty Skin and Hair Clinic 
Address  Ist floor, Onex Square, 75, Shakespeare Sarani Rd Kolkata- 700017, West Bengal, India

Kolkata
WEST BENGAL
700017
India 
Phone  9903275551  
Fax    
Email  dr_abhishek_de@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Mr Swapan Biswas 
Designation  Director-Startup And Regulatory Affairs 
Affiliation  Infoclin LLP 
Address  77/1Y/1, Ibrahimpur Rd, Jadavpur, Kolkata- 700032, West Bengal

Kolkata
WEST BENGAL
700032
India 
Phone  8670254077  
Fax    
Email  swapan@infoclinconsultancy.com  
 
Details of Contact Person
Public Query  
Name  Mr Swapan Biswas 
Designation  Director-Startup And Regulatory Affairs 
Affiliation  Infoclin LLP 
Address  77/1Y/1, Ibrahimpur Rd, Jadavpur, Kolkata- 700032, West Bengal

Kolkata
WEST BENGAL
700032
India 
Phone  8670254077  
Fax    
Email  swapan@infoclinconsultancy.com  
 
Source of Monetary or Material Support  
Glenmark Pharmaceuticals Limited 
 
Primary Sponsor  
Name  Glenmark Pharmaceuticals Limited 
Address  Glenmark House, BD Sawant Marg, Chakala, Andheri East, Mumbai 400 099 INDIA 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
Infoclin LLP  77/1Y/1, Ibrahimpur Rd, Jadavpur, Kolkata-700032, West Bengal 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Abhishek De  Wizderm Specialty Skin and Hair Clinic  Ist floor, Onex Square, 75, Shakespeare Sarani Rd Kolkata- 700017, West Bengal, India
Kolkata
WEST BENGAL 		 9903275551

dr_abhishek_de@yahoo.co.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee HP Poddar Memorial clinic And Nursing Home  Approved 
Institutional Ethics Committee HP Poddar Memorial clinic And Nursing Home  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Minocycline Hydrochloride topical gel 4% plus Oral isotretinoin  Dosage Form is Gel Dosage is Once daily for 12 weeks Dosage Frequency is Once a day Mode of Administration is Once daily preferably at similar time of the day 
Comparator Agent  Oral isotretinoin  Dosage Form is Capsule Dosage is 20 mg Twice daily for 12 weeks Dosage Frequency is Twice daily  
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Patient has completed and signed an appropriately administered Informed Consent Form prior to any study related procedures. Patients less than 18 years of age must sign an Assent Form for the study.
2.Patients who have facial acne vulgaris with an IGA score of moderate 3 or severe 4.
3.Willing and able to apply minocycline gel 4% and take oral isotretinoin capsules as directed comply with study instructions and commit to visit the site for all follow up visits for the duration of the study.
4.If sexually active male patient must practice true abstinence or agree to use contraception during the study. Male patients should refrain from making sperm donations at any time during study participation and for at least 30 days following treatment discontinuation.
5. Willing to minimize exposure of the treated skin to ultraviolet light and extremes in weather such as wind or cold throughout the study.
6.Patient is in good general health and is free of any disease state or physical condition that exposes the patient to an unacceptable risk by study participation or impairs the evaluation of the patient or the treatments by participating in the study. 
 
ExclusionCriteria 
Details  1.Female who is pregnant lactating or breastfeeding, or is planning a pregnancy during the study.
2.Patients having Acne conglobata, acne fulminans secondary acne or any dermatological condition of the face that would require the use of confounding therapies or facial hair that could either interfere with clinical evaluations.
3.Patients with Sunburn on the face.
4.Severe systemic disease that might interfere with the conduct of the study or the interpretation of the results.
5.Abnormal Screening laboratory values that are considered clinically significant
6.Patient is currently enrolled in another investigational drug clinical trial or device study or is using or has used an investigational drug or investigational device treatment within 30 days of randomization.
7.Patient who in the opinion of the investigator, is unable or unlikely to comply with the requirements of the study protocol.
8.Patients excluded who have a history with Allergy to tetracycline class antibiotics or to any ingredient in the study drug, Pseudomembranous colitis or antibiotic-associated colitis, Hepatitis or liver damage or renal impairment, suspected premalignant or malignant disease
9.Patient not eligible, Within 1 week prior to randomization Medicated facial cleansers, Topical acne treatments, within 4 weeks with Topical retinoids on the face, Topical anti inflammatories Topical corticosteroids on body areas other than the face for more than 15 consecutive days and on more than 10 percent of body surface area. In flexural body areas,Systemic antibiotics, Systemic acne treatments Within 12 weeks prior to randomization with Systemic retinoid.
10.Patient has any acute illness within 48 hours, history of sensitivity,depression,Drug addiction or alcohol abuse,previous use of isotretinoin.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the safety of combination of topical minocycline gel 4% and oral isotretinoin vs oral isotretinoin in Indian patients with moderate to severe acne vulgaris.
Evaluation of Treatment Emergent Adverse Events Evaluation of cutaneous tolerability of drugs like signs of cutaneous atrophy, epidermal
thickening/lichenification and abnormal pigmentation changes.
 		 Time Frame is up to 84 days 
 
Secondary Outcome  
Outcome  TimePoints 
Investigator Global Assessment treatment.
improvement or decrease.
Change from baseline in the inflammatory, non-inflammatory and nodulocystic lesion
count.  		 1. IGA at week 4, 8 and 12.
2. Change from baseline in the inflammatory, noninflammatory and nodulocystic lesion
count at Weeks 4, 8 and 12.
 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   N/A 
Date of First Enrollment (India)   10/05/2023 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Non Yet. Will be updated later. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Acne vulgaris is the most common dermatologic disorder globally, affecting approximately 85 percent of the adolescent population, although it can persist into adulthood, therefore affecting almost all age groups. Acne vulgaris is the most common dermatologic disorder globally, affecting approximately 85 percent of the adolescent population, although it can persist into adulthood, therefore affecting almost all age groups.
As per the guidelines, it is suggested to use combination therapy along with oral antibiotics or isotretinoin but monotherapy with antibiotics is contraindicated. Concomitant use of minocycline and isotretinoin is not recommended in view of possibility of pseudo tumor cerebri. But as per one study, concomitant use of oral doxycycline and isotretinoin was found to be safe and effective when used on alternate days.
Though, combination of oral minocycline and isotretinoin is not recommended, topical minocycline was found to 765 times less absorbed systemically and hence all systemic adverse events associated with oral minocycline were nullified by topical minocycline. Hence, the objective of the study is to investigate the safety and efficacy of combination of topical minocycline gel 4% and oral isotretinoin and compare against isotretinoin only in the management of acne vulgaris in Indian population.
 
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