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CTRI Number  CTRI/2025/09/094900 [Registered on: 16/09/2025] Trial Registered Prospectively
Last Modified On: 13/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   A Novel Herbal–Dermatology Blend for Clearer Skin in Acne 
Scientific Title of Study   A multi-action anti acne formulation using Tretinoin, Niacinamide, Zinc and Azadirachta Indica. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Palchuri Sneha Ananya 
Designation  Post graduate 
Affiliation  Saveetha medical college and hospital, Saveetha institute of medical and technical sciences. 
Address  Department of Dermatology, Venereology and Leprosy, Saveetha medical college and hospital, Saveetha institute of medical and technical sciences, Saveetha nagar, Thandalam, Chennai, India

Chennai
TAMIL NADU
602105
India 
Phone  9121349264  
Fax    
Email  Sneha2000Reddy@gmail.com   
 
Details of Contact Person
Scientific Query
 
Name  Dr. Sukesh 
Designation  Assistant professor  
Affiliation  Saveetha medical college and hospital, Saveetha institute of medical and technical sciences. 
Address  Department of Dermatology, Venereology and Leprosy, Saveetha medical college and hospital, Saveetha institute of medical and technical sciences, Saveetha nagar, Thandalam, Chennai, India

Chennai
TAMIL NADU
602105
India 
Phone  9715686909  
Fax    
Email  Sneha2000Reddy@gmail.com   
 
Details of Contact Person
Public Query
 
Name  Palchuri Sneha Ananya 
Designation  Post graduate 
Affiliation  Saveetha medical college and hospital, Saveetha institute of medical and technical sciences. 
Address  Department of Dermatology, Venereology and Leprosy, Saveetha medical college and hospital, Saveetha institute of medical and technical sciences, Saveetha nagar, Thandalam, Chennai, India

Chennai
TAMIL NADU
602105
India 
Phone  9121349264  
Fax    
Email  Sneha2000Reddy@gmail.com   
 
Source of Monetary or Material Support  
Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Chennai 
 
Primary Sponsor  
Name  Dr. Palchuri Sneha Ananya  
Address  Saveetha Medical college and hospital, Saveetha Nagar, Thandalam, Chennai - 602105 
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 
Dr Palchuri Sneha Ananya  Saveetha Medical College and Hospital  Department of Dermatology, Saveetha Medical College and hospital, Saveetha Nagar, Thandalam, Chennai
Chennai
TAMIL NADU 
9121349264

Sneha2000Reddy@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Saveetha Medical College and Hospital Institutional 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  Anti acne cream with Tretinoin, Niacinamide, Zinc and Azadirachta Indica  A topical cream of Tretinoin 0.05%, Niacinamide 5%, Zinc PCA 1%, Azadirachta Indica 3% - topical application for acne to be applied daily night for 2 months 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1. Mild to moderate acne vulgaris based on clinical diagnosis.
2. Willingness to comply with study procedures and provide informed consent.
 
 
ExclusionCriteria 
Details  1. Pregnant or lactating women
2. Severe nodular or cystic acne requiring systemic treatment.
3. Use of systemic Retinoids, Corticosteroids, or other acne treatments in past 5 months that could affect study outcomes.
4. Known allergies or sensitivity to any ingredientsin the study formulation.
5. Unwilling to comply with study procedures.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reduction in lesion count, change in acne severity score  3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Tolerability and safety profile  3 months 
 
Target Sample Size   Total Sample Size="75"
Sample Size from India="75" 
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)   24/09/2025 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Acne is a chronic, self-limiting, inflammatory disease of the pilosebaceous unit, manifesting generally in adolescence with pleomorphic lesions like comedones, papules, pustules, nodules, and cysts and these may lead to scarring. At present Tretinoin has been primarily used for the early stages of acne because of its proven comedolytic benefits and it’s ability to stimulate the growth of new cells, unclog pores and promote the normal flow of sebum, but due it’s irritant effects like redness and dry skin the compliance rate is low. Addition of niacinamide will reduce the irritant effects by hydrating the skin, enhancing skin barrier and reducing the risk of irritation caused by retinol. Niacinamide on it’s own has an anti inflammatory effect that helps in reduction of acne and redness. Niacinamide by decreasing the sebum production, decreases acne breakouts. It also reduces hyperpigmentation by inhibiting enzymes involved in the production of melanin thus helping in reduction of post acne hyperpigmentation and blemishes. Zinc due to it’s anti microbial properties exerts a direct inhibitory action on “acne causing bacteria” and reduces sebum production adding a synergistic effect to Niacinamide. Anti inflammatory and anti microbial properties of neem add to the synergistic effect and reduce acne breakouts. 

Thus a combination of Tretinoin, Niacinamide, Zinc, Neem combats acne effectively eliminating irritant effects of tretinoin. This formulation thus increases the compliance of treatment in patients allowing in effective reduction of acne and increasing self esteem of the patients 


 
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