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CTRI Number  CTRI/2024/12/078553 [Registered on: 24/12/2024] Trial Registered Prospectively
Last Modified On: 23/12/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Topical cream ]  
Study Design  Single Arm Study 
Public Title of Study   Evaluate the safe and efficacy of Hair removal spray 
Scientific Title of Study   A open label, clinical study to evaluate the efficacy and safety of hair removal spray on healthy adult subjects 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
HAIRREMOVSPRAY/07/23, Version: 1.0, Date: 02-12-2024   Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sakthi Balan 
Designation  Consultant 
Affiliation  DK Elite Health Care Centre 
Address  DK Elite Health Care Centre, First Floor, 370, Cuddalore Road, Nainar Mandapam, Velrampet, Puducherry, 605004

Pondicherry
PONDICHERRY
605004
India 
Phone  9843591097  
Fax    
Email  saheerose@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sakthi Balan 
Designation  Consultant 
Affiliation  DK Elite Health Care Centre 
Address  DK Elite Health Care Centre, First Floor, 370, Cuddalore Road, Nainar Mandapam, Velrampet, Puducherry, 605004


PONDICHERRY
605004
India 
Phone  9843591097  
Fax    
Email  saheerose@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Gayathri Sivakumar 
Designation  Director 
Affiliation  KI3 PRIVATE LIMITED 
Address  No 5 3, Dr Jayalakshmi Street, Radha Nagar, Chrompet, Chennai

Chennai
TAMIL NADU
600 044
India 
Phone  09003109416  
Fax    
Email  kai3.mrg@gmail.com  
 
Source of Monetary or Material Support  
Pontika Aerotech Limited, Johron, Himachal Pradesh 173001 
 
Primary Sponsor  
Name  Pontika Aerotech Limited 
Address  Pontika Aerotech Limited, Johron, Himachal Pradesh 173001 
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 Sakthi Balan  DK Elite Health Care Centre  DK Elite Health Care Centre, First Floor 370 Cuddalore Road Nainar Mandapam Velrampet Puducherry 605004
Pondicherry
PONDICHERRY 		 9843591097

saheerose@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ETHIQUE DE LA NATURE ASSOCIATION  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  For hair removal 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Hair Removal spray   • Keep the bottle 10-15 cm away and spray it on the skin • Wait for 8-10 minutes • Under running water, use a spatula in the opposite direction of hair growth • Get rid of unwanted hair in a painless way 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Subjects in generally good health
2. Subjects in the age group of 18-60 years.
3. Subjects with moderate hair growth on forearm, legs and pubic area.
4. Subjects without any cuts, marks and open wounds on forearm, legs and pubic area.
5. Subjects have not used a similar product for the last four weeks.
 
 
ExclusionCriteria 
Details  1. Subjects who have pre-existing or dormant dermatologic conditions (e.g., psoriasis, rosacea, rashes, eczema and severe excoriations).
2. Patients of vulnerable group (children, lactating mother, elderly above 80 years, handicapped, seriously ill, mentally challenged).
3. Subjects with known allergies or sensitivities to cosmetic products, toiletries or its components like fragrances, preservatives, etc.
4. History of allergy to the test product.


 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Hair count reduction in the applied area by comparing with Photographs.
2. Subjects assessment of comfort associated with treatments using a VAS scale. Subjects satisfaction with hair removal treatments and assessment of improvement using a ten point scale.
3. The skin will be evaluated for signs of irritation identified under Erythema and odema, using Draizes scale.
4. a. Ease of application or usage b. Stickiness c. Greasiness and d. Ease of spreading.
5. Product evaluation and product performance feedback questions will be obtained from the participants.  		 Visit 1 (day 1) and visit 2 (Day 2) 
 
Secondary Outcome  
Outcome  TimePoints 
To demonstrate safety and tolerability of study product by Clinical AEs (If any)

Safety and tolerability evaluation criteria:
1. Adverse events and serious adverse events during the study period
2. Brief clinical examination
 		 Visit 1 (day 1) and visit 2 (Day 2) 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   N/A 
Date of First Enrollment (India)   09/01/2025 
Date of Study Completion (India) 04/01/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
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  

·        Study Objective: To evaluate the efficacy, safety, and tolerability of a hair removal spray.

·        Study Design:

ü  30 participants (15 males, 15 females)

ü  Hair removal spray applied for 8-10 minutes, followed by depilation.

ü   24-hour follow-up to assess efficacy and allergic reactions.

ü  Outcome Measurement Timeline: 24-hour follow-up after product use.

·        Primary Outcome Measures:

1.               Hair count reduction by photographic comparison.

2.               Subject comfort assessed using a VAS scale.

3.               Satisfaction with hair removal and improvement using a 10-point scale.

4.               Skin irritation (erythema and edema) evaluated via Draize’s scale.

5.               Product application feedback: ease of use, stickiness, greasiness, spreading, fragrance preferences.

·    secondary Outcomes Measures   :

1.               Monitoring of adverse events and serious adverse events during the study.

2.               Brief clinical examination for allergic reactions or irritations.

·        Participant Criteria:

1.               Inclusion:

§  Healthy adults aged 18-60.

§  Moderate hair growth on forearm, legs, and pubic area.

§  No cuts, marks, or open wounds.

§  No use of similar products in the last 4 weeks.

2.               Exclusion:

§  Pre-existing dermatologic conditions (e.g., psoriasis, eczema).

§  Vulnerable groups (children, elderly >80, mentally challenged).

§  Known allergies or sensitivities to cosmetic products or its ingredients.

 

 
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