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CTRI Number  CTRI/2023/02/050053 [Registered on: 24/02/2023] Trial Registered Prospectively
Last Modified On: 23/02/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   “Comparing topical Clindamycin - Adapalene with oral doxycycline 100mg versus topical Benzoyl peroxide - Adapalene with oral doxycycline 100mg in moderate to severe facial acne vulgaris 
Scientific Title of Study   Comparative study of efficacy, safety and cost effectiveness of topical Clindamycin 1% - Adapalene 0.1% combination therapy with oral doxycycline versus topical Benzoyl peroxide 2.5% - Adapalene 0.1% combination therapy with oral doxycycline in case of moderate to severe facial acne vulgaris: A prospective, randomised, open label parallel study”. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Tamil selvi 
Designation  Junior resident  
Affiliation  AIIMS,NAGPUR 
Address  AIIMS,department of pharmacology,nagpur
AIIMS hospital,nagpur
Nagpur
MAHARASHTRA
441108
India 
Phone  6379896825  
Fax    
Email  etamilselvi11@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Ganesh Dakhale  
Designation  PG guide 
Affiliation  AIIMS,NAGPUR 
Address  Pg married hostel, room 202 ,mihan ,AIIMS
Pg married hostel, room 202 ,mihan ,AIIMS
Nagpur
MAHARASHTRA
441108
India 
Phone  9850539353  
Fax    
Email  gndakhale@aiimsnagpur.edu.in  
 
Details of Contact Person
Public Query
 
Name  Tamil selvi 
Designation  junior resident 
Affiliation  AIIMS,NAGPUR 
Address  AIIMS hospital,Department of Pharmacology,nagpur
AIIMS,nagpur
Nagpur
MAHARASHTRA
441108
India 
Phone  6379896825  
Fax    
Email  etamilselvi11@gmail.com  
 
Source of Monetary or Material Support  
Department of dermatology,AIIMS hospital,NAGPUR 
 
Primary Sponsor  
Name  tamil selvi 
Address  pg married hostel,room no 202,AIIMS,mihan,nagpur 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Tamil selvi  AIIMS,NAGPUR  department of dermatology
Nagpur
MAHARASHTRA 
6379896825

etamilselvi11@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutionalethicscommittee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L088||Other specified local infections of the skin and subcutaneous tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Benzoyl peroxide 2.5% - Adapalene 0.1% with oral doxycycline  Topical FDC - at night FOR 8 WEEKS oral doxycycline - 100mg BD FOR 8 WEEKS  
Intervention  Clindamycin 1% - Adapalene 0.1% with oral doxycycline  Topical FDC - at night FOR 8 WEEKS oral doxycycline - 100mg BD FOR 8 WEEKS  
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  Subjects of either gender.
2. Subjects of 12 to 30 years of age with moderate to severe facial acne vulgaris having ≥ 19 and ≤38 score based on global acne grading system.
 
 
ExclusionCriteria 
Details  Patients already on anti-acne medication(topical or oral) in last one month.
2. Patients having nodulocystic lesions, acne conglobata, acne fulminans, secondary acne.
3. Patients unwilling to give written informed consent.
4. Patients with known hypersensitivity to benzoyl peroxide, clindamycin or adapalene and doxycycline.
5. Pregnant or lactating women.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Efficacy and safety assessed from baseline at 4 and 8 weeks
cost effectiveness assessed at 8 weeks  
From baseline at the end of 4 and 8 weeks,
 
 
Secondary Outcome  
Outcome  TimePoints 
Adverse event
cost effectiveness evaluated 
2,4 AND 8 WEEKS 
 
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)   28/02/2023 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  

Acne vulgaris is a disorder of the pilosebaceous unit that primarily affects adolescents. Cutibacterium acnes(formerly known as P.acnes) which is a commensal bacterium of the cutaneous microbiome playing a crucial role in acne development.Acne is the most common skin disease of adolescence, affecting over 80% of teenagers (aged 13-18 years) at some point. Classically, the pathogenesis of acne has been linked to four key processes viz increased sebum production,alteration of follicular keratinization leading to comedone formation,colonization of the follicle by Cutibacterium acnes,inflammation of pilosebaceous unit. Primary acne lesions include micro-comedones, comedones, papules,pustules,nodules & cysts.Secondary acne lesions include macular erythema, macular pigmentation,atrophic scars & hypertrophic/ keloidal scars. Benzoyl peroxide (BPO) is an effective antimicrobial (bactericidal) & anti-inflammatory and has rapid action, destroying both surface and ductal P. acnes & also possesses mild comedolytic property.Clindamycin is a lincosamide antibiotic and has antibacterial and anti-inflammatory properties.Adapalene being a third-generation retinoid has comedolytic and anti-inflammatory properties.Second-generation tetracyclines– doxycycline,lymecycline and minocycline–are widely recognized as the first oral antibiotic of choice for the treatment of acne.Doxycycline is a lipophilic tetracycline derivative with demonstrated efficacy in the treatment of inflammatory acne.It is available in doses of 50, 75,100 and 150mg;The most frequently prescribed dose for acne is 100mg.Common adverse effects associated with the use of this combination therapy includes Dry skin, irritative contact dermatitis, skin irritation, skin burning sensation, erythema, skin exfoliation.Based on several studies done across the globe regarding the topical combination therapy used in acne vulgaris, some are effective in decreasing the lesions with well tolerability & none of them proved to be helpful in complete recovery of patients.Hence, this study will be conducted to compare the efficacy, safety and cost effectiveness in moderate to severe facial acne vulgaris.A total of 60 patients visiting skin OPD based on eligibility with inclusion criteria,

1

subjects of either gender and subjects of 12 to 30 years of age with moderate to severe facial acne vulgaris having ≥ 19 and ≤38 score based on global acne grading system and after that written informed consent /assent from the subjects will be taken and only then the participants are allowed for a prospective, randomised, open label parallel study for duration of one and a half year at AIIMS Nagpur,will be conducted and Patients will be randomized using computer generated random number table either to receive topical Clindamycin 1% - Adapalene 0.1% combination therapy(0.5 grams applied at night) with oral doxycycline 100mg twice a day or topical Benzoyl peroxide 2.5% - Adapalene 0.1% combination therapy(0.5 grams applied at night)with oral doxycycline 100mg twice a day for 8 weeks and will be followed up at week 4 and 8 and their primary outcomes will be the change in GAGS score from baseline at the end of 8 weeks will be measured by statistical analysis in both groups

 
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