| 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
|
|
|
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
|
|
|
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. |