| 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
|
|
|
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
|
|
|
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
|