A study to evaluate efficacy and safety of 4 Topical Cleanser Formulae on participants with mild to moderate acne.
Scientific Title of Study
Assessment Of Topical Cleanser Formulae Using Clinical Performance On Skin Acne Imperfection Through Instrumental And Dermatologist Assessment, Over 4 Weeks Daily 2x Home Usage.
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
C3B06649; Version: 01, Dated 23Dec25
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Purva Bambhania
Designation
Principal Investigator
Affiliation
Cliantha Research
Address
Consumer Research Department, Corporate House 17, Sigma 1 Corporate House,
BH. Rajpath Club, Off. Sindhubhavan Road, Nr. Mann Party Plot Cross Road, Bodakdev, Ahmedabad-380054-India.
Ahmadabad GUJARAT 380054 India
Phone
8980008193
Fax
Email
pbambhania@cliantha.com
Details of Contact Person Scientific Query
Name
Dr Simran Sethi
Designation
Senior Director-Consumer Research
Affiliation
Cliantha Research
Address
Consumer Research Department, Corporate House 17, Sigma 1 Corporate House,
BH. Rajpath Club, Off. Sindhubhavan Road, Nr. Mann Party Plot Cross Road, Bodakdev, Ahmedabad-380054-India.
Ahmadabad GUJARAT 380054 India
Phone
9825784942
Fax
Email
ssethi@cliantha.com
Details of Contact Person Public Query
Name
Dr Parth Joshi
Designation
Overall Study Coordinator
Affiliation
Cliantha Research
Address
Consumer Research Department, Corporate House 17, Sigma 1 Corporate House,
BH. Rajpath Club, Off. Sindhubhavan Road, Nr. Mann Party Plot Cross Road, Bodakdev, Ahmedabad-380054-India.
Ahmadabad GUJARAT 380054 India
Phone
8000085049
Fax
Email
pjoshi@cliantha.com
Source of Monetary or Material Support
Cliantha Research, Corporate House 17, Sigma 1 Corporate House, BH. Rajpath Club, Off Sindhubhavan Road, Nr. Mann Party Plot Cross Road, Bodakdev, Ahmedabad-380054, Gujarat, India.
Consumer Research Department,
Corporate House 17, Sigma 1 Corporate House,
BH. Rajpath Club, Off Sindhubhavan Road,
Nr. Mann Party Plot Cross Road,
Bodakdev, Ahmedabad-380054, Gujarat. Ahmadabad GUJARAT
8980008193
pbambhania@cliantha.com
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
OM - Institutional Ethics Committee
Approved
Regulatory Clearance Status from DCGI
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Healthy Human Volunteers
Healthy participants with mild to moderate acne.
Intervention / Comparator Agent
Type
Name
Details
Intervention
Face Cleanser
1 ml of test product will be used twice a day starting from Day 00 to Day 27.
Application of neutral moisturizer post application of test product
Intervention
Face Cleanser
1 ml of test product will be used twice a day starting from Day 00 to Day 27.
Application of neutral moisturizer post application of test product
Intervention
Face Cleanser
1 ml of test product will be used twice a day starting from Day 00 to Day 27.
Application of neutral moisturizer post application of test product
Comparator Agent
Face Cleanser
1 ml of test product will be used twice a day starting from Day 00 to Day 27.
Application of neutral moisturizer post application of test product
Inclusion Criteria
Age From
18.00 Year(s)
Age To
35.00 Year(s)
Gender
Both
Details
1) Participants with skin phototype IV – V (1:1) (Fitzpatrick phototype assessed based on ITA0 value. Measurement Site: Back of the participant)
2) Participants having Body Mass Index in the range of 18 to 25 kg per m2. (Note: BMI can be relaxed to 30 kg per m2 in case of recruitment challenges).
3) Participants having oily skin type, according to the investigator.
4) Participants with oily skin as assessed by Sebumeter (Sebum casual level on centre of the forehead greater than or equal to 100 microgram per cm2).
5) Participants presenting with mild (grade 2) to moderate acne (grade 3) severity on an IGA scale from 0 to 4, according to the investigator.
6) Participants with PIH Spot 3mm and above.
7) Participants presenting acne lesions count:
a. greater than or equal to 10 to less than or equal to 25 inflammatory acne lesions on whole face
b. greater than 25 to less than or equal to 100 non-inflammatory acne lesions on whole face
ExclusionCriteria
Details
1) Participants with drug induced acne as disclosed by participants.
2) Participants who have used anti acne products in the last 30 days.
3) Participants who are receiving topical or systemic treatments for acne and PIH within the last 30 days.
4) Participants receiving concomitant medications (e.g., steroids or antihistamines)or surgical condition would compromise the study.
5) Participants with chronic illness which may influence the cutaneous state.
6) Participants having any active dermatological skin diseases (e.g., psoriasis, atopic dermatitis, rosacea etc.), that might interfere with clinical assessments.
7) Participant having excessive hair, moles, open wounds, cuts, abrasions, irritation symptoms, tattoos, scars, sunburn or any dermatological condition on the test site(s) that can interfere with the reading.
8) Participants with any pigmentary disorder including freckles and melasma.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Other
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
TimePoints
1) Dermatological assessment of acne lesions using counting method.
2) Instrumental assessment of the size of PIH
3) Instrumental assessment of Intensity of PIH & Bare Skin
1) Screening Visit, Day 00, Day 03, Day 07, Day 14, Day 28 and Day 35.
2) Screening Visit, Day 00, Day 03, Day 07, Day 14, Day 28 and Day 35.
3) Screening Visit, Day 00, Day 03, Day 07, Day 14, Day 28 and Day 35.
Secondary Outcome
Outcome
TimePoints
Dermatological assessment of Acne Severity using grading scale
Screening Visit, Day 00, Day 03, Day 07, Day 14, Day 28 and Day 35.
Dermatological assessment of skin oiliness using grading scale
Day 00, Day 03, Day 07, Day 14, Day 28 and Day 35.
Dermatological assessment of Redness around Acne lesion using grading scale
Day 00, Day 03, Day 07, Day 14, Day 28 and Day 35.
Dermatological assessment of PIH /Early sign of PIH using grading scale
Day 03, Day 07, Day 14, Day 28 and Day 35.
Instrumental assessment of skin sebum level (SCL and SER)
Screening Visit, Day 00 (before application and after application at 15 mins plus 5 mins (only SER assessments), Day 03, Day 07, Day 14, Day 28 and Day 35.
Instrumental assessment of face hydration
Day 00, Day 03, Day 07, Day 14, Day 28 and Day 35.
Instrumental assessment of skin barrier function
Day 00, Day 03, Day 07, Day 14, Day 28 and Day 35.
Instrumental assessment Overall skin brightness, Redness around acne, acne elevation and on sebaceous pores
Screening Visit, Day 00, Day 03, Day 07, Day 14, Day 28 and Day 35.
Participant Satisfaction Questionnaire (SSA, Health Questionnaire & MWQ)
Screening Visit, Day 00, Day 03, Day 07, Day 14, Day 28 and Day 35.
Assessment of global efficacy and tolerance of investigational products by Dermatologist
Day 03, Day 07, Day 14, Day 28 and Day 35
Target Sample Size
Total Sample Size="200" Sample Size from India="200" 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)
10/01/2026
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="1" Days="19"
Recruitment Status of Trial (Global)
Not Applicable
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
This is a mono-centric, randomized,
parallel group, placebo-controlled, double blinded, comparative study to
evaluate the effectiveness of Topical Cleanser Formulae on Skin Acne
Imperfection Through Instrumental And Dermatologist Assessment, Over 4 Weeks
Daily 2x Home Usage on adult male and female participants with acne, oily skin
and PIH.
The potential participants will be
screened as per the inclusion and exclusion criteria only after obtaining
written informed consent from the participants.
Total Study Duration: 49 days
·Washout Period: At least 14 Days
·Treatment Period: 28 days from
enrollment visit (Day 00)
·Relapse Period: 07 days from the end
of treatment (i.e., Visit 06).
All eligible participants will
undergo clinical evaluation by a Dermatologist, instrument evaluation and
subjective evaluation. Safety will be assessed throughout the study by
assessing the local intolerances and monitoring adverse events.