| CTRI Number |
CTRI/2025/07/091149 [Registered on: 18/07/2025] Trial Registered Prospectively |
| Last Modified On: |
28/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Safety, Efficacy Study] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Clinical Study to Test the Safety and efficacy of test treatment for improving visible signs of facial aging such as wrinkles, fine lines, and dark spots. |
|
Scientific Title of Study
|
A Randomized, Double-Blind, Three-Arm, Prospective, Single-Center Clinical Study to Evaluate the Safety, Efficacy, and Tolerability of Pinorox® in Subjects with Facial Signs of Aging |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NB250027-AP_1.0_08Jul25 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Apeksha Merja |
| Designation |
Principal Investigator |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
NovoBliss Research Pvt. Ltd. Office# 313, Silver Radiance-4, Gota,Ahmedabad
Ahmadabad
GUJARAT
382481
India |
| Phone |
09909013286 |
| Fax |
|
| Email |
dermatology@novobliss.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nayan Patel |
| Designation |
Sub investigator |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
NovoBliss Research Pvt. Ltd. Office# 313, Silver Radiance-4, Gota,Ahmedabad
313, Silver Radiance-4, Gota,
Ahmadabad
GUJARAT
382481
India |
| Phone |
07948983895 |
| 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 |
NovoBliss Research Private Limited, Ahmedabad
NovoBliss Research Pvt. Ltd.
Ahmadabad
GUJARAT
382421
India |
| Phone |
09909013236 |
| Fax |
|
| Email |
maheshvari@novobliss.in |
|
|
Source of Monetary or Material Support
|
| Ambe Phytoextracts Pvt. Ltd
A-144, Sector 63, Noida,
Gautam Buddh Nagar,
Uttar Pradesh - 201305 (INDIA)
|
|
|
Primary Sponsor
|
| Name |
Ambe Phytoextracts Pvt. Ltd |
| Address |
A-144, Sector 63, Noida,
Gautam Buddh Nagar,
Uttar Pradesh - 201305 (INDIA)
|
| Type of Sponsor |
Other [Manufacturing, Marketing and export of Herbal Extracts, Nutraceuticals, phytochemicals] |
|
|
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 Nayan Patel |
NovoBliss Research Private Limited |
313, Silver Radiance-4, Gota,
Ahmedabad, Gujarat, India - 382481
Ahmadabad
GUJARAT |
09909013286
dr.nayan@novobliss.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACEAS – Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L908||Other atrophic disorders of skin, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NA |
| Intervention |
Placebo (Base Cream) |
Mode of Usage: Apply a coin sized (approximately 1 g) amount of the test treatment to the face and gently massage it until fully absorbed.
Frequency: Apply the treatment twice daily
Route of administration: Topical
Dosage Form: Semisolid (Cream)
Storage Condition: Store at room temperature 15°C to 30°C, away from sunlight
Duration: 60 Days
|
| Intervention |
Topical Cream containing 0.1% Pinorox® |
Mode of Usage: Apply a coin size (approximately 1g) amount of the test treatment to the face and gently massage it until fully absorbed.
Frequency: Apply the treatment twice daily
Route of administration: Topical
Dosage Form: Semisolid (Cream)
Storage Condition: Store at room temperature 15°C to 30°C, away from sunlight.
Duration: 60 Days
|
| Intervention |
Topical Cream containing 1% Pinorox® |
Mode of Usage: Apply a coin sized (approximately 1 g) amount of the test treatment to the face and gently massage it until fully absorbed.
Frequency: Apply the treatment twice daily
Route of administration: Topical
Dosage Form: Semisolid (Cream)
Storage Condition: Store at room temperature 15°C to 30°C, away from sunlight
Duration: 60 Days
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1) Age: 35 to 55 years (both inclusive) at the time of consent.
2) Sex: Adult male and female having Crow’s feet area wrinkles, fine lines, facial dark spots.
3) Females of childbearing potential should have a self-reported negative urine pregnancy test at the time of screening visit.
4) Subjects should not have used any cosmetic, nutraceutical or therapeutic products for skin ageing in last 3 months.
5) Subjects are not allowed to participate in any other study until this study is complete.
6) Subjects must be willing and able to follow the study directions and to return for all specified visits with the product.
7) Subjects must agree to record each use of the test products in the subject’s diary card on daily basis.
8) Subjects must agree to record medication use during the study
|
|
| ExclusionCriteria |
| Details |
1) Subjects who are on steroids for last six months.
2) Subjects who have used any cosmetic, nutraceutical or therapeutic products for skin last three months.
3) Subjects who are on product which contains kojic acid, glycolic acid, niacinamide, alpha arbutin, Vitamin C and other skin ageing product.
4) Subjects with other dermatologic diseases whose presence or treatments could interfere with the assessment of study.
5) Subjects that are pregnant and/or breastfeeding.
6) The subject has a known allergy or sensitivity to soaps, lotions, detergents, detanglers or fragrances.
7) Subjects if do not agree to limit sun exposure to affected areas such as face during prolonged sun exposure.
8) The subject has any other skin conditions i.e. cuts, scratches, ring worms, etc. which in the opinion of the Investigator, will interfere with the study results or will create undue risk for the subject.
9) The subject has any of the conditions or factors that the Investigator believes may affect the response of the skin or the interpretation of the test results.
10) The subject is currently taking or has taken any medication, which the Investigator believes may influence the interpretation of the data.
11) Any other condition which could warrant exclusion from the study, as per the dermatologist’s/investigator’s discretion.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the effectiveness of the test treatment(s) by assessing change in
1. skin elasticity and firmness
2. change in skin texture - Crow’s feet area wrinkles, fine lines, pores, roughness, dryness, smoothness
3. change in skin pigmentation and dark spots
4. change in skin colour parameters — L, a, b, and ITA, from baseline to post-treatment, within each treatment group and across treatment groups.
|
Improvement in
1. skin elasticity and firmness through Cutometer Dual MPA 580
2. skin texture evaluated through Visioscan VC 20 Plus
3. skin pigmentation and dark spots evaluated through Mexameter MX 18
4. skin colour parameters — L, a, b, and ITA evaluated through Skin Colorimeter CL 400 from baseline on Day 01 to post treatment assessments on Day 01 at T30 mins, Day 30 and Day 60, assessed within each treatment group and across treatment groups.
|
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| 1. To evaluate the effectiveness of the test treatments by assessing change in skin dryness, redness, fine wrinkling/lines, coarse wrinkles, laxity, roughness and sallowness from baseline to post-treatment, within each treatment group and across treatment groups. |
Day 01 (pre treatment), Day 01 T30 mins, Day 30, Day 60 |
| 2. To evaluate the effectiveness of the test treatments by assessing change in skin wrinkles and fine lines from baseline to post-treatment, within each treatment group and across treatment groups. |
Day 01 (pre treatment), Day 01 T30 mins, Day 30, Day 60 |
| 3To evaluate the effectiveness of the test treatments by assessing change in skin pigmentation from baseline to post-treatment, within each treatment group and across treatment groups. |
Day 01 (pre treatment), Day 01 T30 mins, Day 30, Day 60 |
| 4. To evaluate the effectiveness of the test treatments by assessing change in skin hydration from baseline to post-treatment, within each treatment group and across treatment groups. |
Day 01 (pre treatment), Day 01 T30 mins, Day 30, Day 60 |
| 5. To evaluate the effectiveness of the test treatments by assessing change in skin glow from baseline to post-treatment, within each treatment group and across treatment groups. |
Day 01 (pre treatment), Day 01 T30 mins, Day 30, Day 60 |
| 6. To evaluate the effectiveness of the test treatments by assessing change in facial photographs from baseline to post-treatment, within each treatment group and across treatment groups. |
Day 01 (pre treatment), Day 30, Day 60 |
| 7. To evaluate the effectiveness of the test treatments by assessing change in product perception questionnaire regarding reduction in dark spots, skin appearance, skin hydration, skin texture, reduced fine lines and wrinkles from baseline to post-treatment, within each treatment group and across treatment groups. |
Day 01 (pre treatment), Day 30, Day 60 |
| 2. To evaluate the effectiveness of the test treatments by assessing change in wrinkle intensity, length, width & depth from baseline to post-treatment, within each treatment group & across treatment groups. |
Day 01 (pretreatment), Day 01 T30 mins, Day 30, Day 60 |
|
|
Target Sample Size
|
Total Sample Size="81"
Sample Size from India="81"
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)
|
31/07/2025 |
| 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="2"
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
Modification(s)
|
This is a randomized, double-Blind, three-arm, prospective, single-centre clinical study to evaluate the safety, efficacy, and tolerability of pinorox® in subjects with facial signs of aging. A total of 81 subjects (27 subjects/treatment) will be enrolled in the study, comprising male and non-pregnant, non-lactating female participants aged 35 to 55 years (inclusive). Subjects must present with visible Crow’s feet wrinkles, fine lines, and facial dark spots at baseline. Participants will be equally distributed across three treatment groups with 27 subjects per group. There will be total of 3 visits during the study. The duration of the study will be 60 Days (8 weeks) from the enrolment. Subjects will be instructed to visit the facility as per below visits. ü Visit: 01 (Day 01, Week 00): Screening, ICD obtained, Enrolment, Baseline readings and post product usage readings. ü Visit 02 (Day 30, Week 04): Treatment Phase, Evaluations ü Visit 03 (Day 60, Week 08): Evaluations and Treatment Phase end | End of Study |