Treatment of Freckles by Intradermal Tranexamic Acid Versus Q Switched KTP Laser.
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ClinicalTrials.gov Identifier: NCT03885895 |
Recruitment Status :
Recruiting
First Posted : March 22, 2019
Last Update Posted : March 22, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Therapeutic Efficacy | Drug: Tranexamic Acid Injectable Product Device: Q switched KTP (532nm) | Phase 1 |
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 (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Allocation: | Randomized |
Intervention Model: | Sequential Assignment |
Masking: | Double (Participant, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Comparative Study for the Treatment of Freckles by Intradermal Tranexamic Acid Versus Q Switched KTP Laser (532nm) |
Actual Study Start Date : | January 15, 2019 |
Estimated Primary Completion Date : | August 2019 |
Estimated Study Completion Date : | December 2019 |

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

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Gender Based Eligibility: | Yes |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03885895
Contact: Samar Tuqan | 01003133495 ext 02 | samartuqan@gmail.com |
Egypt | |
Kasr El Ainy university hospital | Recruiting |
Cairo, Egypt, 11956 | |
Contact: Samar Tuqan 01003133495 ext 02 samartuqan@gmail.com |
Responsible Party: | Rana F Hilal, MD, Lecturer, Kasr El Aini Hospital |
ClinicalTrials.gov Identifier: | NCT03885895 |
Other Study ID Numbers: |
EgyFreckles |
First Posted: | March 22, 2019 Key Record Dates |
Last Update Posted: | March 22, 2019 |
Last Verified: | March 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
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 |
Melanosis Hyperpigmentation Pigmentation Disorders Skin Diseases Tranexamic Acid |
Antifibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Hemostatics Coagulants |