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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03885895
Recruitment Status : Recruiting
First Posted : March 22, 2019
Last Update Posted : March 22, 2019
Sponsor:
Information provided by (Responsible Party):
Rana F Hilal, MD, Kasr El Aini Hospital

Study Description
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Brief 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).

Condition or disease Intervention/treatment Phase
Therapeutic Efficacy Drug: Tranexamic Acid Injectable Product Device: Q switched KTP (532nm) Phase 1

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 Design
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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

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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


Eligibility Criteria
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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
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Samar Tuqan 01003133495 ext 02 samartuqan@gmail.com

Locations
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Egypt
Kasr El Ainy university hospital Recruiting
Cairo, Egypt, 11956
Contact: Samar Tuqan    01003133495 ext 02    samartuqan@gmail.com   
Sponsors and Collaborators
Kasr El Aini Hospital
More Information
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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

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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
Additional relevant MeSH terms:
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Melanosis
Hyperpigmentation
Pigmentation Disorders
Skin Diseases
Tranexamic Acid
 Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants