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

Primary Purpose

Therapeutic Efficacy

Status
Unknown status
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Tranexamic Acid Injectable Product
Q switched KTP (532nm)
Sponsored by
Kasr El Aini Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Therapeutic Efficacy

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

  • Kasr El Ainy university hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Participants with freckles (one side of the face)

Participants with freckles (other side of the face)

Arm Description

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

other side will be treated by Q switched KTP laser

Outcomes

Primary Outcome Measures

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
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
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
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

Secondary Outcome Measures

Full Information

First Posted
March 20, 2019
Last Updated
March 20, 2019
Sponsor
Kasr El Aini Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03885895
Brief Title
Treatment of Freckles by Intradermal Tranexamic Acid Versus Q Switched KTP Laser.
Official Title
Comparative Study for the Treatment of Freckles by Intradermal Tranexamic Acid Versus Q Switched KTP Laser (532nm)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 15, 2019 (Actual)
Primary Completion Date
August 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kasr El Aini Hospital

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Therapeutic Efficacy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Participants with freckles (one side of the face)
Arm Type
Active Comparator
Arm Description
one randomized side of the face will be treated by Intradermal Tranexamic acid
Arm Title
Participants with freckles (other side of the face)
Arm Type
Active Comparator
Arm Description
other side will be treated by Q switched KTP laser
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid Injectable Product
Intervention Description
Ampoules used for intradermal injection
Intervention Type
Device
Intervention Name(s)
Q switched KTP (532nm)
Intervention Description
LASER
Primary Outcome Measure Information:
Title
Pigmentation and severity index by clinical evaluation
Description
Evaluate efficacy of intradermal tranexamic acid versus Q switched KTP laser in the treatment of freckles before treatment, after treatment and after follow-up
Time Frame
6 months to 1 year
Title
Melanin Index change by spectrophotometer
Description
Evaluate efficacy of intradermal tranexamic acid versus Q switched KTP laser in the treatment of freckles before treatment, after treatment and after follow-up
Time Frame
6 months to 1 year
Title
Blinded observers' evaluation
Description
Evaluate efficacy of intradermal tranexamic acid versus Q switched KTP laser in the treatment of freckles before treatment, after treatment and after follow-up
Time Frame
6 months to 1 year
Title
Patient satisfaction rate
Description
Evaluate efficacy of intradermal tranexamic acid versus Q switched KTP laser in the treatment of freckles before treatment, after treatment and after follow-up
Time Frame
6 months to 1 year

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Samar Tuqan
Phone
01003133495
Ext
02
Email
samartuqan@gmail.com
Facility Information:
Facility Name
Kasr El Ainy university hospital
City
Cairo
ZIP/Postal Code
11956
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samar Tuqan
Phone
01003133495
Ext
02
Email
samartuqan@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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