NCT03885895

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 22, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

March 22, 2019

Status Verified

March 1, 2019

Enrollment Period

7 months

First QC Date

March 20, 2019

Last Update Submit

March 20, 2019

Conditions

Therapeutic Efficacy

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

Participants with freckles (one side of the face)

ACTIVE COMPARATOR

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

Drug: Tranexamic Acid Injectable Product

Participants with freckles (other side of the face)

ACTIVE COMPARATOR

other side will be treated by Q switched KTP laser

Device: Q switched KTP (532nm)

Interventions

Tranexamic Acid Injectable ProductDRUG

Ampoules used for intradermal injection

Participants with freckles (one side of the face)
Q switched KTP (532nm)DEVICE

LASER

Participants with freckles (other side of the face)

Eligibility Criteria

Age18 Years - 60 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Both genders
  • Age group \> 18years old.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr El Ainy university hospital

Cairo, 11956, Egypt

RECRUITING

Central Study Contacts

Samar Tuqan

CONTACT

01003133495samartuqan@gmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

March 20, 2019

First Posted

March 22, 2019

Study Start

January 15, 2019

Primary Completion

August 1, 2019

Study Completion

December 1, 2019

Last Updated

March 22, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)