| CTRI Number |
CTRI/2024/09/073528 [Registered on: 06/09/2024] Trial Registered Prospectively |
| Last Modified On: |
28/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluating the Effectiveness of G-Lite® Cream with Cristello® Sunscreen in Treating Hyperpigmentation |
|
Scientific Title of Study
|
A study to assess the effectiveness of the G-Lite® cream with Cristello® sunscreen for hyperpigmentation |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Protocol ID: CACS-GBL-001, version 1.2 Dated: 18 Jul 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr B S Chandrashekar |
| Designation |
Medical Director and Chief Hair transplant Dermatosurgeon |
| Affiliation |
CUTIS Academy of Cutaneous Sciences |
| Address |
Department of Dermatology
Room No:1 5/1 4th Main MRCR Layout Vijayanagar Bangalor Bangalore KARNATAKA 560040 India |
| Phone |
9740091155 |
| Fax |
|
| Email |
cacs0312@hotmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr B S Chandrashekar |
| Designation |
Medical Director and Chief Hair transplant Dermatosurgeon |
| Affiliation |
CUTIS Academy of Cutaneous Sciences |
| Address |
Department of Dermatology
Room No:1 5/1 4th Main MRCR Layout Vijayanagar Bangalor Bangalore KARNATAKA 560040 India |
| Phone |
9740091155 |
| Fax |
|
| Email |
cacs0312@hotmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr B S Chandrashekar |
| Designation |
Medical Director and Chief Hair transplant Dermatosurgeon |
| Affiliation |
CUTIS Academy of Cutaneous Sciences |
| Address |
Department of Dermatology
Room No:1 5/1 4th Main MRCR Layout Vijayanagar Bangalor Bangalore KARNATAKA 560040 India |
| Phone |
9740091155 |
| Fax |
|
| Email |
cacs0312@hotmail.com |
|
|
Source of Monetary or Material Support
|
| CUTIS Academy of Cutaneous Sciences Address: 5/1 4th Main MRCR Layout Vijayanagar, Bangalore 560040 |
|
|
Primary Sponsor
|
| Name |
Gufic Biosciences Ltd |
| Address |
SM House 11, Sahakar Road, 1st to 4th Floor, IN Maharashtra |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Roopa MS |
CUTIS Academy of Cutaneous Sciences |
CUTIS Academy of Cutaneous Sciences
Department of Dermatology Room No:1
5/1 4th Main MRCR Layout Vijayanagar Bangalore KARNATAKA |
9738406761
medicalwriter@cutis.org.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CUTIS Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L814||Other melanin hyperpigmentation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
G-lite Cream
Artocarpus Extract (Oxyresveratrol) 0.1% + Kojic Acid Dipalmitate 2% + Arbutin 1.5% + Licorice Extract 1% + Niacinamide 3% + Mulberry Extract 1% + Alpha Tocopherol 1% + Allantoin 0.1% + Hyaluronic Acid 0.05% + Sabi White 0.1% + Octinoxate 7.5% |
G-Lite® Cream: Apply 1 gram of the cream once daily at night to the affected areas on the face for a total duration of 12 weeks. Route of administration: Topical
Cristello® Sunscreen (SPF 50): Apply 1 gram of sunscreen topically three times a day (at 8:30 AM, 11:30 AM, and 2:30 PM) for a total duration of 12 weeks. Route of administration: Topical |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1.Female and male patients, from 18-45 years of age with hyperpigmentation
2.Participants who are willing to provide a written informed consent and photo consent form
3.Participants who are willing to follow up for three visits over a period of 12 weeks (approximately).
4.Participants who are able and willing to follow all the study procedures including abstinence from usage of any OTC product related to face applications.
5.Participants who are willing to be clinically photographed as per protocol |
|
| ExclusionCriteria |
| Details |
1.Patient who is not willing to participate in the study.
2.Patients who are using other pigment reduction creams. (Except sunscreen, a base moisturiser)
3.Subjects with other dermatological disorder of the face that may interfere with the study evaluation (Acne, DPN, Seborrheic melanosis)
4.Subjects with known hypersensitivity to any of the study drugs or constituents.
5.Subjects who are expected to be exposed to the triggering factors. (Excessive sun exposure, UVB photo therapy, use of OCPs)
6.Patient who has received facial procedures like dermabrasion, chemical peels or laser procedures within the last 1 month.
7.Any patient as per investigator’s opinion is unfit for participation in the study.
8.Pregnant / lactating females |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect assessed in terms of reduction in epidermal pigmentation assessed clinically, dermoscopically and by using Fotofinder. |
After 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the effect of G-lite on reduction of hyperpigmentation by using Dermacatch, clinical assessment, Dermoscopic & photographic assessment baseline visit (visit1, Day 0). They will be followed on Visit 2, (6th week) and Visit 3, (12th week). |
After 3 Months |
|
|
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
10/09/2024 |
| Date of Study Completion (India) |
17/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| 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
|
Pigmentation disorders can be an
issue for all individuals, especially those with skin of color. Although the
natural pigmentation in patients with skin of color provides many advantages
such as sun protection and slowed signs of aging, it also increases
susceptibility to hyperpigmentation, which can have a negative psychological
impact. Both physicians and dermatology patients are searching for long-term
topical skin care solutions (both cosmetic and cosmeceutical) to address
problems presented by skin hyperpigmentation.
Traditional depigmenting agents, although
highly effective, can raise several safety concerns (for example, ochronosis,
atrophy, carcinogenesis, and other local or systemic side effects) with
long-term exposure. Active compounds isolated from plants, such as arbutin,
aloesin, gentisic acid, flavonoids, hesperidin, licorice, niacinamide, yeast
derivatives, and polyphenols, inhibit melanogenesis without melanocytotoxicity
by different mechanisms.
Artocarpus
extract is derived from the dried Artocarpus lakoocha heartwood with the
major being Oxyresveratrol.It has depigmenting effect by non-competitive
inhibition of tyrosinase activity with safety profiles and available at low
cost. Arbutin and Deoxyarbutin are botanicals that are
structurally similar to HQ. Arbutin, causes decreased tyrosinase activity
without affecting messenger RNA expression, while also inhibiting melanosome
maturation without being toxic to melanocytes. Kojic acid is a hydrophilic molecule derived from species of
Aspergillus and Penicillium, acting as a tyrosinase inhibitor that chelates
copper at the enzyme’s active site. Licorice
extracts are skin-lightening agents with the fewest side effects. Because
of its benign profile, liquorice extract is one of the most widely used agents
in cosmeceuticals for skin brightening. It inhibits tyrosinase, leading to
inhibition of melanogenesis. Licorice extract also has topical
anti-inflammatory and anticarcinogenic properties. Niacinamide is
physiologically active amide of niacin. It has a beneficial effect on skin
which includes reduction in cutaneous pigmentation by inhibition of melanosome transfer
to keratinocytes, anti-inflammatory action, prevention of photo carcinogenesis
and production of ceramides which enhances epidermal permeability barrier
function. Alpha-Tocopherol (Vitamin E) is a lipophilic antioxidant derived
from cereals, nuts, vegetable oils in human body. It has a major role in
scavenging free radicals and the depigmented effect can be attributed to its
inhibitory action on tyrosinase and increase in intracellular glutathione.
Mulberry extract is derived from the leaves of Morbus alba L, which has
anti-hyperglycaemic activity. The skin lightening effect of mulberry extract is
due to its inhibition of dopa oxidase activity of tyrosinase and free radical
scavenger. Hyaluronic acid specifically makes up the extracellular matrix of
skin which has a unique property of hydrating the skin and has an anti-ageing
effect. Octinoxate is a cinnamate ester, organic sunscreen which mainly filters
UVB rays.
Pigment lightening is an integral
component of dermatologic therapy, and there are many safe treatments with
varying degrees of efficacy that can be employed. Adding sunscreen to the
treatment regimen and patient education regarding sun protection measures also
will be beneficial in the management of patients with pigmentation. The
management of hyperpigmentation can be challenging, |