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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  
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 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  
Status 
Not Applicable 
 
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,

 
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