FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/03/063756 [Registered on: 07/03/2024] Trial Registered Prospectively
Last Modified On: 29/02/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Other 
Public Title of Study   Open label, Single arm, comparative study of fractional co2 and fractional co2 with tranexamic acid in Acanthosis Nigricans 
Scientific Title of Study   A Split face comparison study of Fractional Co2 and Fractional Co2 With Tranexamic Acid In Acanthosis Nigricans 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
CACS (23-24)-006, Version:1 dated:20 Oct 2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Madura C 
Designation  Medical Director and Chief Hair transplant Dermatosurgeon 
Affiliation  CUTIS Academy of Cutaneous Sciences 
Address  Department of Dermatology Room No:10
5/1 4th main MRCR Layout Vijayanagar
Bangalore
KARNATAKA
560040
India 
Phone  9632741998  
Fax    
Email  maduradr@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Madura C 
Designation  Medical Director and Chief Hair transplant Dermatosurgeon 
Affiliation  CUTIS Academy of Cutaneous Sciences 
Address  Department of Dermatology Room No:10
5/1 4th main MRCR Layout Vijayanagar

KARNATAKA
560040
India 
Phone  9632741998  
Fax    
Email  maduradr@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Madura C 
Designation  Medical Director and Chief Hair transplant Dermatosurgeon 
Affiliation  CUTIS Academy of Cutaneous Sciences 
Address  Department of Dermatology Room No:10
5/1 4th main MRCR Layout Vijayanagar

KARNATAKA
560040
India 
Phone  9632741998  
Fax    
Email  maduradr@gmail.com  
 
Source of Monetary or Material Support  
CUTIS Academy of Cutaneous Sciens 5/1,4th Main, MRCR layout, Vijayanagar, bangalore 560040 
 
Primary Sponsor  
Name  NA 
Address  NA 
Type of Sponsor  Other [NA] 
 
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 Madura C  CUTIS Academy of Cutaneous Sciences  Department of dermatology Room No:10 5/1,4th Main, MRCR layout, Vijayanagar, bangalore 560040
Bangalore
KARNATAKA 
9632741998

maduradr@gmail.com 
 
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: L83||Acanthosis nigricans,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Fractional CO2 laser  On the left side of the face, normal saline will be rubbed into the skin The wavelength of 10,600nm, energy30-50mJ, a frequency of 50-100Hz, a density of 3-4%, and with 1-2 passes, the procedure will be done one time only at the time of baseline, then follow up for assessment is 6 weeks and 12 weeks  
Intervention  Fractional Co2 With Tranexamic Acid  On the right side of the face, tranexamic acid (500mg/5ml) will be rubbed into the skin The wavelength of 10,600nm, energy of 30-50mJ, a frequency of 50-100Hz, a density of 3-4%, and with 1-2 passes, the procedure will be done one time only at the time of baseline, then follow up for assessment is 6 weeks and 12 weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients diagnosed with AN of the face.
2.Age above 18 to 60 years.
 
 
ExclusionCriteria 
Details  1.Active herpes infection
2.Keloidal tendency/ scarring post laser
3.Pregnancy
4.Uncontrolled Diabetes
5.Systemic diseases as connective tissue disease
6.History of drug intake
7.Underlying malignancy
8.History of any procedures for treatment of AN at least 1 month before enrolment.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The response to treatment will be evaluated by clinical examination and photographic comparison at baseline and during each follow up every month for 3 months post laser session.  After 3 m onths 
 
Secondary Outcome  
Outcome  TimePoints 
The response to treatment will be evaluated by clinical examination and photographic comparison at baseline and during each follow up every month for 3 months
Acanthosis Nigricans Area and Severity Index (ANASI) Score and Acanthosis Nigricans Scoring Chart done at baseline and after 6 weeks 
After 3 months 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" 
Phase of Trial   N/A 
Date of First Enrollment (India)   14/03/2024 
Date of Study Completion (India) 17/10/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
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  

Acanthosis nigricans (AN) is a chronic skin disorder that is characterized clinically by velvety darkening of the skin mainly at the back of the neck and also includes face, axilla, cubital fossa, knuckles and groin region. It is most commonly associated with diabetes and insulin resistance, or hormonal disorders, certain drugs such as steroids and oral contraceptives, and rarely internal malignancy. Thus, acanthosis nigricans is an indicator of metabolic syndrome in many diseases such as psoriasis, lichen planus, and atopic dermatitis.

Treatment is usually challenging. However, the condition usually improves by treating the cause as in the case of insulin resistance and weight loss. Other treatment modalities include keratolytics, such as topical retinoids (eg, topical tretinoin 0.1%), topical vitamin D analogues (eg, calcipotriol 0.005%), oral retinoids, octreotide, dermabrasion, and chemical peels with variable outcome.

In addition, various types of lasers have been used for managing AN as long-pulsed alexandrite laser, ablative carbon dioxide laser, fractional 1550-nm erbium fibre, and fractional CO2 laser with variable treatment results.

Fractional CO2 laser acts by fractionated photothermolysis by making skin columns of thermal injury known as micro-thermal zones. It improves the condition by removing thin layers of skin with minimal thermal damage leading to collagen injury and collagen remodelling. The latter helps in improving both the texture and thickness of the skin. In addition, transepidermal elimination of the dermal content is a possible mechanism by which the melanin is eliminated.

Tranexamic acid (TA) is an antifibrinolytic, reversibly binding to plasminogen, and thus preventing its conversion to plasmin and subsequent breakdown of fibrin. Additionally, TA reduces expression of vascular endothelial growth factor and endothelin-1, which also acts to minimize bleeding and hamper angiogenesis.

There remains a significant gap in comprehensive research focusing specifically on the combined efficacy of fractional CO2 laser therapy with tranexamic acid for treating AN. This study evaluates the need for fractional co2 and fractional co2 with tranexamic acid in acanthosis nigricans.

 
Close