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CTRI Number  CTRI/2025/01/078924 [Registered on: 17/01/2025] Trial Registered Prospectively
Last Modified On: 25/11/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Real-World, Observational study 
Study Design  Other 
Public Title of Study   Effectiveness of Acne Skin Care Products on Mild to Moderate Acne.  
Scientific Title of Study
Modification(s)  		 A Real-World Observational Study to Evaluate the Effectiveness of Skin Care Products Containing Thymol and Terpineol in Treating Mild to Moderate Acne 
Trial Acronym  NA 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anil K V Minz 
Designation  Dermatologist 
Affiliation  Genesis Skin Clinic,Faridabad 
Address  Genesis Skin Clinic, Sector 21d, Faridabad - 121001

Faridabad
HARYANA
121001
India 
Phone  9811980464  
Fax    
Email  anilminz@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Ms Sneha Ranade 
Designation  R and D  
Affiliation  Hindustan Unilever Limited  
Address  Hindustan Unilever Limited B. D. Sawant Marg, Chakala, Andheri (E, Mumbai, Maharashtra 400053

Mumbai
MAHARASHTRA
400053
India 
Phone  9892000156  
Fax    
Email  SNEHA.RANADE@unilever.com  
 
Details of Contact Person
Public Query  
Name  Dr Deepika Mehta  
Designation  Marketing Manager  
Affiliation  Hindustan Unilever Limited  
Address  Hindustan Unilever Limited B. D. Sawant Marg, Chakala, Andheri (E, Mumbai, Maharashtra 400053

Mumbai
MAHARASHTRA
400053
India 
Phone  9599547353  
Fax    
Email  Deepika.Mehta@unilever.com  
 
Source of Monetary or Material Support  
Hindustan Unilever Limited, Unilever House, B.D. Sawant Marg, Chakala, Andheri (E),Mumbai, Maharashtra, 400099. India. 
 
Primary Sponsor  
Name  Hindustan Unilever Limited  
Address  B. D. Sawant Marg, Chakala, Andheri (E, Mumbai, Maharashtra 400053 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sandeep Mahapatra  Derma Solutions, Bangalore  Shop 3, 1st floor, Scorpio house Near Marathahalli Bridge Munnekoala, opp. Purvankara Apt, Bengaluru, Karnataka 560037
Bangalore
KARNATAKA 		 8904432458

sandeep.mahapatra@dermasolutions.co.in 
Dr Rohit Batra  Dermaworld Clinic, Delhi  Q-4, Rajouri Garden, New Delhi - 110027
New Delhi
DELHI 		 9911200050

drrohitbatra@gmail.com 
Dr Punit Saraogi  Everything Skin & Hair, Mumbai  Everything Skin & Hair, Royal Chambers, 101, Gulmohar Rd, Juhu, Mumbai, Maharashtra 400049
Mumbai
MAHARASHTRA 		 9833300156

drpunitsaraogi@gmail.com 
Dr Anil K V Minz   Genesis Skin Clinic, Faridabad  Genesis Skin Clinic, Sector 21d, Faridabad - 121001
Faridabad
HARYANA 		 9811980464

anilminz@yahoo.com 
Dr Anju Methil  Skin and Shape Clinic, Mumbai  Skin and Shape Clinic 302,Aston Sundervan, Lokhandwala Rd, Andheri West, Mumbai, Maharashtra 400053
Mumbai
MAHARASHTRA 		 9819776377

anju.methil@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 6  
Name of Committee  Approval Status 
ACE Independent Ethics Committee  Approved 
Good Society for Ethical Research IEC Delhi   Approved 
Good Society for Ethical Research IEC Delhi  Approved 
Indira IVF Hospital Ethics Committee - Kolkata  Approved 
Indira IVF Hospital Ethics Committee - Mumbai  Approved 
Indira IVF Hospital Ethics Committee - Mumbai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L709||Acne, unspecified, (2) ICD-10 Condition: L700||Acne vulgaris,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Subjects who meet all of the following criteria will be included in the study.
1) Indian subjects (20% male and 80% female subjects) with mild-to-moderate acne, from more than or equal to 18 years to less than or equal to 40 years of age at the time of consent.
2) Subjects with mild to moderate acne condition (Grade 2 to 3 as per Investigator Global Assessment [IGA] scale).
3) Subjects with normal Fitzpatrick skin type III to VI (human skin color determination scale).
4) Subjects who have been prescribed either the 0.1% thymol + terpineol (Serum) or 0.35% thymol + terpineol (Cleanser) for acne treatment as per the investigator discretion will be invited to participate in the study and provide their data, with no changes to the prescribed treatment.
5) Subjects are able to follow their normal skin routines and refrain from introducing any similar skin care products for acne during the study.
6) Subjects are willing to give written informed consent and are willing to comply with the study protocol.
 
 
ExclusionCriteria 
Details  1) Subject has a history of allergy or sensitivity to the study product ingredients.
2) Subjects with severe acne conditions, i.e. cysts, and/or nodules, as determined by the investigator/treating doctor.
3) Subjects who have pre-existing or dormant dermatologic conditions (e.g. psoriasis rashes, eczema, seborrheic dermatitis, or any other) that could interfere with the outcome of the study as determined by the investigator.
4) Subject has used any systemic therapy with chronic antibiotic therapy, retinoids, and/or oral steroids during the 4 weeks before the start or anticipates having to use at any point during the study.
5) Pregnant or lactating females or planning to become pregnant during the study period.
6) Subjects participating in other similar cosmetics, devices, therapeutic trials, or skin care products within the last 4 weeks. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Alternation 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Change in the acne reduction from baseline  Day 1 to days 7, 14, 28, and 56 using the IGA scale. 
 
Secondary Outcome  
Outcome  TimePoints 
1)Change in post inflammatory hyperpigmentation using PIH scale.
2)Change in post acne hyperpigmentation using PAH scale.
3)Quality of life using the Acne-QoL.
4)Subject perception on study products using the self assessment questionnaire after product application.
5)Change in Subject Response Index after product application.  		 Assessments will be done on Baseline Day 1, Day 7, Day 14, Day 28 and Day 56.  
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   31/01/2025 
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="0"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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
Modification(s)  		 Acne vulgaris is a common skin disease that affects above 85% of people at some time during their lifetime. It is characterized as either non-inflammatory (open/black and closed/white comedones) or inflammatory (papules, pustules, nodules, and cysts), leading to scar development and pigmentation on the skin. These skin conditions affect the quality of life in multiple dimensions, including psychosocial consequences, such as anxiety and depression. Topical retinoids, benzoyl peroxide, salicylic acid, glycolic acid, azelaic acid, and combinations of topical agents are currently considered the first-line choice in acne management. Combining retinoids with other topical agents, procedures, and oral therapies is also recommended. The major limitations of these therapies are side effects, such as hypersensitivity reactions and cutaneous irritation at the application site.
Novology leverages the patented TT2 Technology which is a synergistic combination of thymol–terpineol (TT) in the Acne products. TT2 technology-based formulations are hypoallergenic, suitable for sensitive skin, and help in reducing acne with minimum irritation at the application site which is the limitation of topical retinoids. This combination inhibits and targets the acne-causing bacteria (C acnes) while rebalancing the microbiome, which are essential for regulating our skin’s health.

This study is a real-world, observational, multicentric clinical study of 0.1% thymol + terpineol (Serum) and 0.35% thymol + terpineol (Cleanser) (acne serum vs cleanser) in the reduction of mild-to-moderate acne lesions. The cleanser or serum will have to be applied on the face for 8 weeks (56 days). Study visits will consist of screening and follow-up visits on Day 1, Day 7 ± 2 days, Day 14 ± 2 days, Day 28 ± 2 days, and Day 56 ± 2 days.

The Primary objective is To evaluate the effectiveness of acne serum and acne cleanser together and acne serum alone on inflammatory/non-inflammatory acne lesions on the face of subjects with mild-to-moderate acne. 

Dermatological assessments, subjects’ self-assessment questionnaire, Acne-QoL questionnaire, and subjects’ perception of the product will be assessed. Safety events if any reported by subjects will be recorded. The results of the Study will be published in a peer-reviewed international journal. In accordance with the Declaration of Helsinki, both authors and publishers have ethical obligations. 

 
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