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CTRI Number  CTRI/2024/08/071879 [Registered on: 05/08/2024] Trial Registered Prospectively
Last Modified On: 27/01/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Safety, Efficacy Study]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Clinical safety and efficacy study of test products in mild to moderate acne patients.  
Scientific Title of Study   Prospective, evaluator-blinded, randomized, three-arm, comparative, in-use tolerability, three-products, safety and efficacy study in mild to moderate acne patients 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NB240017-CL 1.0  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nayan Patel 
Designation  Principal Investigator-Medical Director 
Affiliation  NovoBliss Research Private Limited 
Address  NovoBliss Research Pvt. Ltd. Office# A - 206, 2nd Floor, Shaligram Lakeview Business Complex, Nr. Vaishnodevi Circle, Khoraj,

Gandhinagar
GUJARAT
382421
India 
Phone  9909013286  
Fax    
Email  dr.nayan@novobliss.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Nayan Patel 
Designation  Principal Investigator-Medical Director 
Affiliation  NovoBliss Research Private Limited 
Address  NovoBliss Research Pvt. Ltd. Office# A - 206, 2nd Floor, Shaligram Lakeview Business Complex, Nr. Vaishnodevi Circle, Khoraj,

Gandhinagar
GUJARAT
382421
India 
Phone  9909013286  
Fax    
Email  dr.nayan@novobliss.in  
 
Details of Contact Person
Public Query  
Name  Maheshvari Patel 
Designation  Director Operations and Strategic Management 
Affiliation  NovoBliss Research private Limited 
Address  NovoBliss Research Pvt. Ltd. Office# A - 206, 2nd Floor, Shaligram Lakeview Business Complex, Nr. Vaishnodevi Circle, Khoraj,

Gandhinagar
GUJARAT
382421
India 
Phone  9909013286  
Fax    
Email  maheshvari@novobliss.in  
 
Source of Monetary or Material Support  
Cipla Limited Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel Mumbai india, 400013 
 
Primary Sponsor  
Name  Cipla Limited 
Address  Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel Mumbai, India 400013  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
Nil  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Nayan Patel  NovoBliss Research Pvt. Limited  clinical trial department, office A 206, NovoBliss Research Pvt. Limited Office# A - 206, 2nd Floor, Shaligram Lakeview Business Complex, Nr. Vaishnodevi Circle, Khoraj, Gandhinagar – 382421, Gujarat – India
Gandhinagar
GUJARAT 		 9909013286

dr.nayan@novobliss.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ACEAS – Independent Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L700||Acne vulgaris,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Test Product A: 1% Salicylic Acid foaming face wash.   Mode of Usage: Take two actuations and gently massage product all over wet face. Avoid eyes and surrounding areas. Allow it to remain for 20-30 seconds. Rinse face thoroughly and pat dry. Route of Administration- Topical. Frequency - Twice a day. Dose: required amount Dosage Form: Face Wash Total Duration: 28 days 
Intervention  Test Product B: 2% Salicylic Acid foaming face wash  Mode of Usage: Take two actuations and gently massage product all over wet face. Avoid eyes and surrounding areas. Allow it to remain for 20-30 seconds. Rinse face thoroughly and pat dry. Route of Administration- Topical. Frequency - Twice a day. Dose: required amount Dosage Form: Face Wash Total Duration: 28 days 
Comparator Agent  Test Product C- Glycolic acid facewash   Mode of Usage: Wet your face with water. Gently massage the foam all over your face for 20-30 seconds. Rinse thoroughly with water and pat dry. Route of Administration- Topical. Frequency-Twice a day Dose: Required amount Dosage Form: face wash Total Dueation: 28 Days 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  35.00 Year(s)
Gender  Both 
Details  1)Age: 16 to 35 years (both inclusive) old at the time of consent.
2) Sex: Healthy adult males and non-pregnant/non-lactating females. (Preferably equal number
of males and females will be enrolled in the study)
3) Females of childbearing potential have a self-reported negative urine pregnancy test at the
time of the screening visit and agree to follow an accepted method of birth control for the
duration of the study such as condoms, foams, jellies, diaphragm, intrauterine device etc.
4) Patients are generally in good general health as determined from recent medical history.
5) Patients with acne of mild to moderate severity as per the IGA scale.
6) Patients who commit not to use medicated skincare products (OTC products, cosmeticcomedogenic products, moisturizing products, anti-acne and anti-seborrhoeic products) other
than the test product for the entire duration of the study.
7) Patients is able to remain on stable doses of contraceptive or replacement hormonal therapy,
including no therapy, 6 weeks prior to and for the duration of the study.
8) If the Patients is of childbearing potential, is practicing and agrees to maintain an established
method of birth control (IUD, hormonal implant device/injection, regular use of birth control
pills or patch, diaphragm, condoms with spermicide or sponge with spermicidal jelly, cream or
foam, partner vasectomy or abstinence). Females will be considered as non-childbearing
potential if they are surgically sterile, have been post-menopausal for at least 1 year or have
had a tubal ligation.
9) Patients are willing to give written informed consent and are willing to come for regular follow
up.
10) Patients who have not participated in a similar investigation in the past three months.
11) Willing to use test product throughout the study period.
 
 
ExclusionCriteria 
Details  1)History of any dermatological condition of the skin disease.
2) Subject with present condition of allergic response to any cosmetic product.
3) Subjects under chronic medication (e.g. aspirin-based products, anti-inflammatories, antihistamines, corticosteroid therapy etc.) that might influence the outcome of the study.
4) Subject having acne of severe incidence (presence of nodules, cysts) which requires
pharmaceutical product.
5) Subjects had performed any acne treatment throughout the study.
6) Subjects who have applied topical product for at least 4 weeks and any systemic product for
at least 3 months, adjuvant product/therapy before they participated in the study.
7) History of alcohol or drug addiction
8) Subjects using other marketed anti-acne products during the study period.
9) Any other condition which could warrant exclusion from the study, as per the
dermatologist’s/investigator’s discretion.
10) Pregnant or breastfeeding or planning to become pregnant during the study period.
11) History of chronic illness which may influence the cutaneous state.
12) Subjects participating in other similar cosmetics, devices or therapeutic trials or skincare
products within the last four weeks.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the effectiveness of the test products in terms of
1. change in sebum level.
2. change in acne severity by investigator global assessment scale. (IGA Scale) 		 Before usage of the test products on Day 01 and after usage of test products at T20 mins on Day 01, Day 07, Day 28 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the effectiveness of the test products in terms of
1. change in total acne lesions.
2. change in sum of open and closed comedones.
3. change in sum of papules and pustules.
4. change in pore size, acne size, and acne count.
5. change in fluorescing acne lesions.
6. change in skin glow.
7. change in skin barrier function (Trans Epidermal Water Loss).
8. change in skin hydration.
9. To evaluate the safety and cutaneous acceptability of test products in terms of change in erythema, scaling, peeling, itching, irritation, redness, burning,
dryness.
10.To assess the effectiveness of the test products in terms of subject
product perception questionnaire.
11. To assess the effectiveness of the test product in terms of organoleptic
assessment by subjects 		 before usage of the test products on Day 01 and after usage at T20 mins on Day 01, Day 07, Day 28. 
 
Target Sample Size   Total Sample Size="96"
Sample Size from India="96" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   12/08/2024 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="0"
Days="28" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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 is prospective, interventional, evaluator-blinded, randomized, comparative, three-arm, safety, In-Use tolerability and efficacy study in mild to moderate acne patients. . Total of 96 subjects (32 subjects/test product) will be enrolled to complete 90 (30 subjects/test product) complete the study.
Total 3 visits were included.
Visit 01 (Day 01): Screening and Enrolment, Baseline Evaluations
Visit 02 (Day 07 ±2 days): Test Product Usage Period, Evaluations
Visit 03 (Day 28 ±2 days): Evaluations, End of Study 
 
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