| CTRI Number |
CTRI/2024/06/069086 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
14/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Other (Specify) [Lasers and chemical peels] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing outcome between oral tranexamic acid 250mg with 35 percent Glycolic acid peels versus oral tranexamic acid with low fluency q switched nd-yag laser |
|
Scientific Title of Study
|
Comparative efficacy and safety of Oral Tranexamic acid with 35 percent Glycolic acid peels and Oral Tranexamic acid with low Fluence Q Switched ND-YAG Laser in treatment of Melasma. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr N Deekshitha |
| Designation |
Junior resident |
| Affiliation |
Esic medical college and hospital |
| Address |
Esic medical college and hospital
MD Dermatology
Op building 4th floor ,room num 413
Sanathnagar ,Hyderabad
500038
Esic medical and hospital sanathnagar
Hyderabad 500038
Hyderabad
TELANGANA
500038
India |
| Phone |
9398028534 |
| Fax |
|
| Email |
Ndeekshitha63@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Archana mavoori |
| Designation |
Associate professor |
| Affiliation |
Esic medical college and hospital |
| Address |
Esic medical college and hospital
MD Dermatology
Op building 4th floor ,room num 413
Sanathnagar ,Hyderabad
500038
Esic medical college and hospital
Hyderabad
TELANGANA
500038
India |
| Phone |
8297230045 |
| Fax |
|
| Email |
Archana.mavoori@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr B Purna chandra |
| Designation |
Hod and professor |
| Affiliation |
Esic medical college and hospital |
| Address |
Esic medical college and hospital
MD Dermatology
Op building 4th floor ,room num 413
Sanathnagar ,Hyderabad
Esic medical college and hospital
Hyderabad
TELANGANA
500038
India |
| Phone |
9490452059 |
| Fax |
|
| Email |
Sunpurna123@gmail.com |
|
|
Source of Monetary or Material Support
|
| Esic medical college and hospital ,sanathnagar ,Hyderabad Telangana
India 500038 |
|
|
Primary Sponsor
|
| Name |
N Deekshitha |
| Address |
Esic medical college and hospital sanathnagar Hyderabad 500038 |
| Type of Sponsor |
Other [Self] |
|
|
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 N Deekshitha |
Esic medical college and hospital |
Esic medical college and hospital
MD Dermatology
Room num 413 ,4th floor op building
sanathnagar Hyderabad 500038
Hyderabad
TELANGANA |
9398028534
Ndeekshitha63@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee ESIC medical college and hospital and ESIC super speciality hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L00-L99||Diseases of the skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Oral Tranexamic acid with 35
Percent Glycolic acid peels and oral Tranexamic acid with low fluence Q switched ND YAG Laser |
Patients with melasma fulfilling the inclusion criteria are taken into consideration and divided into 2 group ,one group will receives oral tranexamic acid with 35 percent glycolic acid peels and other group will receive oral tranexamic acid with low fluence q switched nd yag laser ,each person is randomly selected to receive either of the treatment.
Group A- 100 patients will receive oral tranexamic acid 250 mg twice a day with 35percentage of glycolic acid peel for a period of 3 months with 2 weeks intervals gap total of 6 sessions . Patients are advised to apply only sunscreen or topical
emollient twice daily for 2 weeks after session
Group B- 100 patients will receive the oral tranexamic acid 250mg twice daily with low fluence q switched nd -yag laser for a period of 3 months with 2 weeks interval gap ,total of 6 sessions .The treatment settings will be spot size with 6 to 10 mm, fluence 0.5 -3.00 j/cm2, and of long wavelength 1064 m. The number of passes varies from 1 to 10. |
| Comparator Agent |
Comparison between oral Tranexamic acid with 35 percent Glycolic acid peels and Oral Tranexamic acid with low fluence Q switched ND-YAG Laser. |
Patients with melasma fulfilling the inclusion criteria are taken into consideration and divided into 2 group ,one group will receives oral tranexamic acid with 35 percent glycolic acid peels and other group will receive oral tranexamic acid with low fluence, 9 switched nd yag laser each person is randomly selected to receive either of the treatment.
Group A- 100 patients will receive oral tranexamic acid 250 mg twice a day with 35percentage of glycolic acid peel for a period of 3 months with 2 weeks intervals gap total of 6 sessions. Patients are advised to apply only sunscreen or topical emollient twice dailv for 2 weeks after session
Group B- 100 patients will receive the oral tranexamic acid 250mg twice daily with low fluence q switched nd -yag laser for a period of 3 months with 2 weeks interval gap ,total of 6 sessions .The treatment settings will be spot size with 6 to 10 mm, fluence 0.5 -3.00 j/cm2, and of long wavelength 1064 m. The number of passes varies from 1 to 10. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All people under age group 18 to 60 are included |
|
| ExclusionCriteria |
| Details |
Age less than 18 ,pregnancy, lactation, increased Bt,Ct, Pt-inr, using oral contraceptives pills ,pre existing inflammation dermatoses-atopic dermatitis ,systemic lupus ervthematosus, photo dermatoses, active infections, h/o contact dermatitis to glycolic acid products, thromboembolism, h/o intake of drugs with photosensitizing potential ,patients with keloid tendencies, patients with unrealistic expectations |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| compare the efficacy of oral tranexamic acid with 35 percent glycolic acid peel and oral tranexamic acid with low fluence q switched nd-yag laser after 4 weeks and 12 weeks of post procedure |
After 4 weeks and 12 weeks of post procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find out the percentage of improved pigmentation in the lesions after 4 weeks & 12 weeks of post treatment . |
Outcomes viewed after 4 weeks & 12 weeks post procedure |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
30/06/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Melasma a chronic acquired hypermelanosis affecting mainly the face (malar regains,chin,forehead ,upper lips) mainly triggered by uv radiations ,hormones and by genetically influence ,in which pathogenesis includes triggering of melanocytes, interaction between keratinocytes, mast cells, gene regulation abnormalities,neovascularization,disruption of basement membrane and hormones .Many treatment options are available with unsatisfactory results ,so combination methods like Oral tranexamic acid with 35 percent glycolic acids peels to randomly selected 100 patents with 2 weeks interval gap ,total 6 sessions for 3 months durations and oral tranexamic acid with low fluence q switched nd- yag laser to randomly selected 100 patients with 2 weeks interval gap ,total 6 sessions for 3 months duration.clinical examination for decreased pigmentation is done by using mMASI(Melasma area severity index) after the end of procedure. |