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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05884151
Other study ID # Cmh abbottabad321
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date November 1, 2022
Est. completion date April 30, 2023

Study information

Verified date May 2023
Source Combined Military Hospital Abbottabad
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

ABSTRACT Objective: To study the efficacy while comparing Intralesional tranexamic acid Vs Platelets rich plasma (PRP) in treatment of Melasma. Study design: Randomized-controlled trial (RCT). Study setting and duration: Dept of dermatology, CMH-Abbottabad, Nov-2022 /April-2023. Methodology: The sample size of 60 patients 20 to 40 years were calculated by using Openepi App. The informed consent was taken. The patients were randomly allocated to two groups: Group A (30 patients injected with Intradermal Tranexamic acid (4mg/ml) and Group B (30 patients treated with PRP (1ml) intra-dermally, every fourth week for up to 12 weeks between both groups). The mMASI scale was used to evaluate all patients. The final evaluation was performed on the 24th week of follow-up. For analysis Statistical Package for the social sciences version-27 was used. To determine statistical significance a paired t-samples test with a p-value of < 0.05 was applied.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date April 30, 2023
Est. primary completion date April 30, 2023
Accepts healthy volunteers No
Gender All
Age group 20 Years to 40 Years
Eligibility Inclusion Criteria: - 20_40 years of age - suffering from melasma Exclusion Criteria: - pregnancy - breastfeeding mothers - allergic to tranexamic acid - bleeding disorders - warts or facial eczema

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Tranexamic acid
Group A 30 patients treated with Intradermal Tranexamic acid injection (4mg/ml) for preparation an insulin syringe was used with a volume of 1ml containing 0.04 ml of TXA and the reminder being normal saline to ensure 4mg preparation in each insulin syringe
Platelets rich plasma
Group B 30 patients prescribed with PRP (1ml) intra-dermally PRP was obtained manually by a two-step procedure using a centrifuge machine. First spin was performed at 1500 RPM for 10 minutes. Second spin was performed at 4000 RPM for 10 minutes. Thus, obtaining a two-part plasma. Upper two third was platelet poor plasma and was discarded. Lower one third was platelets rich plasma. Before injection applying 0.1 ml calcium chloride was added for each 1 ml of PRP to activate the platelets. PRP was injected 1 ml by using 30 G needle (insulin syringe) in each cm2 of melasma.

Locations

Country Name City State
Pakistan Dr sana aslam Abbottabad Khyber Pakhtun Khwaa
Pakistan Sana aslam Abbottabad Khyber Pakhtun Khwa
Pakistan Sana aslam Abbottabad Khyber Pakhtun Khwa

Sponsors (1)

Lead Sponsor Collaborator
Combined Military Hospital Abbottabad

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Melasma severity index Modified melasma area severity score is used to measure effectiveness of both drugs in treatment of melasma Score value ranges from 0-24 . 24 means melasma is more severe 24 weeks
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