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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

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

Conditions
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Therapeutic Efficacy

Intervention / Treatment
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* Drug: Tranexamic Acid Injectable Product
* Device: Q switched KTP (532nm)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 |