FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/03/050239 [Registered on: 02/03/2023] Trial Registered Prospectively
Last Modified On: 29/04/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Cosmetics]  
Study Design  Single Arm Study 
Public Title of Study   A Clinical Study to determine Safety, Efficacy, In-Use Tolerability Study of HDSC-022209. 
Scientific Title of Study   A Clinical Study to Evaluate Safety, Efficacy and In-Use Tolerability Study of HDSC-022209 in Healthy Adult Human Subjects in Reduction in Facial dark Spots. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
HWC/MSCD/CPD/002/2023 Version 01 (Final), 13Feb23  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Apeksha Merja Patel 
Designation  Principal Investigator 
Affiliation  NovoBliss Research Private Limited 
Address  Office-A - 206, 2nd Floor, Shaligram Lakeview Business Complex, Near Vaishnodevi Circle, Khoraj, Gandhinagar, Gujarat, India Gandhinagar GUJARAT 382421 India

Gandhinagar
GUJARAT
382421
India 
Phone  9909013286  
Fax    
Email  dermatology@novobliss.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Nayan Patel 
Designation  Principal Investigator-medical director 
Affiliation  NovoBliss Research Private Limited 
Address  Office-A - 206, 2nd Floor, Shaligram Lakeview Business Complex, Near Vaishnodevi Circle, Khoraj, Gandhinagar, Gujarat, India GUJARAT 382421 India

Gandhinagar
GUJARAT
382421
India 
Phone  9909013286  
Fax    
Email  dr.nayan@novobliss.in  
 
Details of Contact Person
Public Query  
Name  Maheshvari Patel 
Designation  Director Operations and Strategic Management 
Affiliation  NovoBliss Research Private Limited 
Address  Office-A - 206, 2nd Floor, Shaligram Lakeview Business Complex, Near Vaishnodevi Circle, Khoraj, Gandhinagar, Gujarat, India Gandhinagar GUJARAT 382421

Gandhinagar
GUJARAT
382421
India 
Phone  9909013236  
Fax    
Email  maheshvari@novobliss.in  
 
Source of Monetary or Material Support  
Himalaya Wellness Company Makali, Bengaluru 562 162, India  
 
Primary Sponsor  
Name  Himalaya Wellness Company 
Address  Makali, Bengaluru 562 162, India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Not Applicable 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Apeksha Merja  NovoBliss Research Pvt. Limited  Department - Clinical Trials Office-A - 206, 2nd Floor, Shaligram Lakeview Business Complex, Near Vaishnodevi Circle, Khoraj, Gandhinagar – 382421, Gujarat – India Gandhinagar GUJARAT
Gandhinagar
GUJARAT 		 91-79-48983895

dermatology@novobliss.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ACEAS – Independent Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  18 to 55 years old healthy subject with facial dark spot 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  HDSC-022209   Gently massage a generous quantity of the test product on cleansed face and neck until fully absorbed Use twice daily (preferably morning and evening before time) 
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1) Age: 18 to 55 years (both inclusive) at the time of consent.
2) Sex: Healthy non-pregnant/non-lactating females and Males.
3) Subject has facial dark spots preferably equal ratio of tan, blemishes, sunspots, and age spots.
4) Female of childbearing potential must have a reported negative pregnancy during screening.
5) Subject is generally in good health.
6) Subject is not undergone any cosmetic procedures or any medication for the treatment of acne 3 months prior to study enrolment.
7) Subject is able to follow their normal skin care routines and to refrain from introducing any new skin care products during the study.
8) Willing to forgo use of all other topical acne medications or antibiotics during the study period or any treatment duration of the study
9) Subject is able to forgo changes in baseline medications and nutritional supplements, any other anti-acne facial cream, powder, face mask etc. during the study period.
10) If the female subject is of childbearing potential, is practicing and agrees to maintain an established method of birth control (IUD, hormonal implant device/injection, regular use of birth control pills or patch, diaphragm, condoms with spermicide or sponge with spermicidal jelly, cream or foam, partner vasectomy or abstinence). Females will be considered as non-childbearing potential if they are surgically sterile, have been post-menopausal for at least 1 year or have had a tubal ligation.
11) Subject is willing not to introduce any new soaps, cleansers, lotions, creams, or any other face product etc. for the duration of the study.
12) Subject is willing to give written informed consent and are willing to follow the study procedure.
13) The subject is willing to use test product throughout the study period.
 
 
ExclusionCriteria 
Details  1) Subject has a history of allergy or sensitivity to the test product ingredients.
2) Subject who has a history of allergy with products containing turmeric or any known ingredients.
3) Subject who has pre-existing or dormant dermatologic conditions (e.g., psoriasis rashes, eczema, seborrheic dermatitis, acne, acne rosacea or any other) that could interfere with the subject selection and outcome of the study as determined by the Investigator.
4) Subject has taken any systemic therapy with chronic antibiotic therapy, retinoids, and/or oral steroids during the 4 weeks prior to the start or anticipates having to use at any point during the study.
5) Subject using any topical retinoids within 2 weeks of the screening visit or anticipates having to use at any point during the study.
6) Subject is not willing to avoid unprotected sun or other UV radiation exposure during the study period.
7) Subject has a history of alcohol or drug addiction.
8) Subject has a history of prior use of scar removal, spots reduction, skin radiance or wrinkles laser treatment within 3 months.
9) Any other condition which could warrant exclusion from the study, as per the dermatologist’s/Investigator’s discretion.
10) Subject has a history of chronic illness which may influence the cutaneous state.
11) Subjects participating in other similar cosmeceuticals, cosmetics or therapeutic trials or skin care products within the last 4 weeks.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
change in the
1. facial dark spots
2. Change in faical dark spot and erythema
3.change in the facial wrinkles and fine lines of Crow’s feet area, skin texture
4.change in the facial skin elasticity
5.change in the facial skin oiliness
6.change in the facial skin hydration
7.change in the facial skin glow
8.change in the facial skin barrier functions 		 baseline Day01 before application to Day 01 (Instant readings at T0 i.e. 20 mins post application), Day 7, Day 14, Day21 and Day 28 
 
Secondary Outcome  
Outcome  TimePoints 
1. change in Physician Global Assessment
2. change in Glogau Skin Age
3. change in Skin Oiliness, hydration, skin glow, and skin pores
4. change in facial photographs
5. consumer feedback on skin texture 		 baseline Day01 before application to Day 01 (Instant readings at T0 i.e. 20 mins post application), Day 7, Day 14, Day21 and Day 28 
 
Target Sample Size   Total Sample Size="42"
Sample Size from India="42" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="42" 
Phase of Trial   N/A 
Date of First Enrollment (India)   13/03/2023 
Date of Study Completion (India) 11/04/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="0"
Days="28" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

This study is designed as an -open label, single arm, single-center, efficacy, safety, skin compatibility, and in-use tolerability stdy of HDSC-022209 in adult human subjects from 18 to 55 years with facial dark spots. The subject will be instructed to visit the facility as per the below visit.

           Visit 1 (Day 1): Screening and Enrolled Day 1,

           Visit 2 (Day 7): Product usage Period, Evaluation visit

           Visit 3 (Day 14): Product usage Period, Evaluation visit

          Visit 4 (Day 21):  Product usage Period, Evaluation visit

          Visit 5 (Day 28):  Product usage Period End, End of the Study visit.

The main objective of this study is to determine the effectiveness of test products i.e. change in a facial dark spot, erythema, facial wrinkles, fine lines of crows feet area, skin texture, skin elasticity, skin oiliness, skin glow, skin hydration, skin barrier function, change in PGA scoring, change in Glogau skin age, change in skin type, change in facial photograph.


 

 
Close