Treatment of Freckles by Intradermal Tranexamic Acid Versus Q Switched KTP Laser.

Comparative Study for the Treatment of Freckles by Intradermal Tranexamic Acid Versus Q Switched KTP Laser (532nm)

Comparative split face study in which 30 patients with freckles are recruited.One side of the face will be treated with Q Switched (QS)KTP 532nm, and the other side will be treated with intradermal tranexamic acid (TXA).

Study Overview

• Status: Unknown
• Conditions: Therapeutic Efficacy
• Intervention / Treatment: Drug: Tranexamic Acid Injectable Product; Device: Q switched KTP (532nm)

Detailed Description

One side of the face will receive QS KTPlaser at a wavelength of 532 nm, spot size 2-3 mm , power 1-1.5J/cm2 and the clinical end point is just frosting.Sessions will be every month for 2 months.

The other side of the face will be assigned to TXA intradermal microinjection in the same session using Kapron 500mg/5ml ampoules (Amoun Pharmaceutical Company), the dose of 1 ml syringe with 100mg/ml. TXA will prepared under sterile conditions. Injections will be applied intradermally on freckles area at.

The sessions of TXA will be every 2 weeks for 2 months.

Postoperatively, topical antibiotic ointment and steriod will be applied. Sunscreen then applied until the next treatment in order to minimize reactive hyperpigmentations.

Follow up after treatment monthly for 2 month.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11956
    • Recruiting
    • Kasr El Ainy university hospital
    • Contact: Samar Tuqan; Phone Number: 02 01003133495; Email: samartuqan@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Both genders
• Age group > 18years old.

Exclusion Criteria:

• Pregnant and lactating females.
• Keloid and scarring tendancy
• Usage of invasive or semi invasive procedures for treatment of freckles such as chemical peeling , dermaroller..etc. 2 months prior to the study.
• Oral Isotretinoin 6 months prior to the study.
• Active herpetic lesions.
• Any concurrent active skin disease within the treated area.
• Photosensitive skin conditions such as systemic lupus erythematous.
• History of delayed wound healing.
• Bleeding diathesis.
• Medical conditions such as autoimmune diseases.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Participants with freckles (one side of the face); one randomized side of the face will be treated by Intradermal Tranexamic acid	Drug: Tranexamic Acid Injectable Product; Ampoules used for intradermal injection
Active Comparator: Participants with freckles (other side of the face); other side will be treated by Q switched KTP laser	Device: Q switched KTP (532nm); LASER

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pigmentation and severity index by clinical evaluation	Evaluate efficacy of intradermal tranexamic acid versus Q switched KTP laser in the treatment of freckles before treatment, after treatment and after follow-up	6 months to 1 year
Melanin Index change by spectrophotometer	Evaluate efficacy of intradermal tranexamic acid versus Q switched KTP laser in the treatment of freckles before treatment, after treatment and after follow-up	6 months to 1 year
Blinded observers' evaluation	Evaluate efficacy of intradermal tranexamic acid versus Q switched KTP laser in the treatment of freckles before treatment, after treatment and after follow-up	6 months to 1 year
Patient satisfaction rate	Evaluate efficacy of intradermal tranexamic acid versus Q switched KTP laser in the treatment of freckles before treatment, after treatment and after follow-up	6 months to 1 year

Collaborators and Investigators

• Sponsor: Kasr El Aini Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2019
• Primary Completion (Anticipated): August 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: March 20, 2019
• First Submitted That Met QC Criteria: March 20, 2019
• First Posted (Actual): March 22, 2019

Study Record Updates

• Last Update Posted (Actual): March 22, 2019
• Last Update Submitted That Met QC Criteria: March 20, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Hyperpigmentation; Pigmentation Disorders; Melanosis; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: EgyFreckles

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes