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

Kasr El Aini Hospital

Status and phase: Unknown; Phase 1

Conditions: Therapeutic Efficacy

Treatments: Drug: Tranexamic Acid Injectable Product; Device: Q switched KTP (532nm)

Study type: Interventional

Funder types: Other

Identifiers

NCT03885895

EgyFreckles

Details and patient eligibility

About

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).

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

---

30 participants in 2 patient groups

Participants with freckles (one side of the face)

Active Comparator group

Description:

one randomized side of the face will be treated by Intradermal Tranexamic acid

Treatment:

Drug: Tranexamic Acid Injectable Product

Participants with freckles (other side of the face)

Active Comparator group

Description:

other side will be treated by Q switched KTP laser

Treatment:

Device: Q switched KTP (532nm)