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

Therapeutic Efficacy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03885895
• Other study ID #: EgyFreckles
• Status: Recruiting
• Phase: Phase 1
• Start date: January 15, 2019
• Est. completion date: December 2019

Study information

• Verified date: March 2019
• Source: Kasr El Aini Hospital
• Contact: Samar Tuqan
• Phone: 01003133495
• Email: samartuqan[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Therapeutic Efficacy

Intervention

Drug:
• Tranexamic Acid Injectable Product
Ampoules used for intradermal injection

Device:
• Q switched KTP (532nm)
LASER

Locations

Country	Name	City	State
Egypt	Kasr El Ainy university hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Kasr El Aini Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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