| CTRI Number |
CTRI/2024/10/075429 [Registered on: 17/10/2024] Trial Registered Prospectively |
| Last Modified On: |
16/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Topical cream ] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To assess the efficacy and safety of Orah Glo E for bright and radiant skin. |
|
Scientific Title of Study
|
A randomized, open label, interventional clinical study to assess the efficacy and safety of Orah Glo E for bright and radiant skin. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ORAHGLOE/22/24, Version No: 1.0, Dated: 27.09.2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Roshany |
| Designation |
Dermatologist |
| Affiliation |
DK Elite Health Care Centre |
| Address |
DK Elite Health Care Centre,
First Floor,
No.370, Cuddalore main Road, Nainarmandapam, Puducherry-605 004
Pondicherry
PONDICHERRY
605004
India |
| Phone |
09943805988 |
| Fax |
|
| Email |
roshanysakthibalan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Roshany |
| Designation |
Dermatologist |
| Affiliation |
DK Elite Health Care Centre |
| Address |
DK Elite Health Care Centre,
First Floor,
No.370, Cuddalore main Road, Nainarmandapam, Puducherry-605 004
Pondicherry
PONDICHERRY
605004
India |
| Phone |
09943805988 |
| Fax |
|
| Email |
roshanysakthibalan@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 |
9003109416 |
| Fax |
|
| Email |
drgayathri@ki3services.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Orah Nutrichem Pvt. Ltd |
| Address |
Office 215,216 Kohinoor Arcade,
Tilak chowk, Pune Mumbai highway, Nigdi, Pune 411044. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Roshany |
DK Elite Health Care Centre |
DK Elite Health Care Centre,
Room No 02,Dermatologist
First Floor,
No.370, Cuddalore main Road, Nainarmandapam, Puducherry-605 004
Pondicherry
PONDICHERRY |
09943805988
roshanysakthibalan@gmail.com |
| Dr J Shankari |
H4U Clinic |
H4U clinic
Room No 1, dermatologist & Cosmetologist
4 170, KR Building, First floor Old Mahabalipuram Road Egattur.
Chennai
TAMIL NADU |
09791190730
drshankarij@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| ETHIQUE DE LA NATURE ASSOCIATION |
Approved |
| Oxymed Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L810||Postinflammatory hyperpigmentation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
ORAH GLO E |
Ingredients:
1. Vitamin E -Tocotrienol Rich Fraction
2. Medium Chain Triglycerides
3. GML
4. Ascorbyl Palmitate
Dosage: 0.5 - 3%
Usage instructions: Twice a day- Sufficient quantity of cream to be taken and apply to cover the whole face.
Duration: 28 days
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1.Female subjects who are 18 to 45 years of age. (skin types IV to V)
2.Patients with Melasma, Post acne pigmentation, post inflammatory hypermelanosis, Seborrhoeic melanosis, Photo tanning and Frictional melanosis will be included.
3.Subjects not have participated in any other clinical trial during the past 3 months
|
|
| ExclusionCriteria |
| Details |
1.Having major treatment, including topical hydroquinone or tretinoin, cryotherapy, electrosurgery, trichloroacetic acid application, laser or intense pulsed light, in the 3 months before the beginning of the study
2.Past history of allergy to whitening cosmetic products
3.Past history of atopic dermatitis
4.Habit of frequent sun exposure longer than 4 hours per day
5.Pregnant or lactating women.
6.Hypersensitivity to any of the components of the test formulation.
7.The presence of any other condition that leads the investigator to
conclude that the patient is inappropriate for inclusion in this clinical study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.The study will evaluate the efficacy of the treatment through multiple assessment tools.
2.The investigator will measure the mean reduction in hyperpigmentation at baseline and after 4 weeks using the Investigator Global Assessment (IGA).
3.Photo damage will also be evaluated with IGA at both time points.
4.Crows feet wrinkles will be assessed using Bazins scale at baseline and week 4.
5.Skin quality will be assessed by both the investigator and the subject, focusing on radiance, smoothness, pigmentation, and other factors, with scores ranging from 1 to 10.
6.Skin brightness and wrinkle reduction will be measured using Cutometer and Chromameter or Mexameter at baseline, week 1, 2, and 4.
7.Global improvement will be evaluated by the subject and investigator through self-assessment and photographs. Based on primary outcomes, the treatment’s efficacy will be scored from 0 (no effect) to 4 (excellent effect).
|
Visit 1 - Day 1
Visit 2 - Day 7
Visit 3 - Day 14
Visit 4 - Day 28
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To monitor for any adverse events during the study period and assess quality of life
|
Visit 1 - Day 1
Visit 2 - Day 7
Visit 3 - Day 14
Visit 4 - Day 28 |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "24"
Final Enrollment numbers achieved (India)="24" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
30/10/2024 |
| Date of Study Completion (India) |
18/03/2025 |
| Date of First Enrollment (Global) |
30/10/2024 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
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
|
Participants: 24 randomized into a single group Inclusion Criteria: - Female subjects, 18-45 years old (skin types IV to V).
- Diagnosed with Melasma, Post-acne pigmentation, Post-inflammatory hypermelanosis, Seborrhoeic melanosis, Photo tanning, or Frictional melanosis.
- No participation in any other clinical trial in the past 3 months.
Exclusion Criteria: - Major treatment (e.g., topical hydroquinone, tretinoin, cryotherapy, laser, IPL) in the past 3 months.
- History of allergies to whitening products.
- Past history of atopic dermatitis.
- Frequent sun exposure >4 hours/day.
- Pregnant or lactating women.
- Hypersensitivity to any study formulation components.
- Any condition deemed inappropriate by the investigator for study inclusion.
Primary Outcome Measures:
1. Hyperpigmentation Reduction: Mean decrease in darkness of the target area assessed by Investigator Global Assessment (IGA) at baseline and 4 weeks. 2. Photo Damage: IGA assessment of photo damage at baseline and 4 weeks. 3. Wrinkle Evaluation: Crow’s feet wrinkles assessed using the Bazin scale at baseline and 4 weeks. 4. Skin Quality Assessment: Grading of radiance, smoothness, pigmentation, erythema, pore size, clarity, brightness, tone, luminosity, and complexion (1-10 scale). 5. Skin Brightness & Wrinkle Reduction: Measured by Cutometer and Chromameter/Mexameter at baseline, Day 7, Day 14, and Day 28. 6. Global Improvement: Self-assessment and investigator evaluation of overall improvement (improved, unchanged, or deteriorated) at the end of the study. 7. Efficacy Scoring: Investigator’s assessment of treatment efficacy (0 = no effect, 1 = poor, 2 = reasonable, 3 = good, 4 = excellent).
Secondary Outcome Measure:
1. Monitoring of adverse events and assessment of quality of life during the study period. |