NCT05909072

Brief Summary

Topical tranexamic, a hydrophilic molecule, can't pass the lipid barriers of the stratum corneum and it's also not retained in adequate amount in the epidermis to enter the melanocytes, so there's a difficulty in the effective delivery of tranexamic acid into the melanocytes . Hyaluronic acid was proved to improve the effective delivery of tranexamic acid through loosening corneocyte packing and helping TXA entering the melanocytes and minimizing its epidermal diffusion .

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
27

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2023

Shorter than P25 for phase_2

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 18, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

June 18, 2023

Status Verified

June 1, 2023

Enrollment Period

5 months

First QC Date

February 17, 2023

Last Update Submit

June 9, 2023

Conditions

Melasma

Outcome Measures

Primary Outcomes (5)

  • Modified Melasma Area Severity Index (mMASI) score

    Hemi-mMASI for each half of the face is calculated according to the following formula: Hemi-mMASI = 0.15 (A) (D) F + 0.3 (A) (D) M + 0.05 (A) (D) C

    through study completion, an average of 9 months

  • Physician global evaluation

    The improvement of patients is evaluated regarding the improvement in mMASI ( ) and graded as follow: Poor (improvement \< 25%) Fair (improvement 26%-50%) Good (improvement 51%-75%) Excellent (improvement \>75%)

    through study completion, an average of 9 months

  • A five-point Likert scale for patient's satisfaction

    Level of patient satisfaction is scored on five points: 1. Not at all satisfied 2. Not really satisfied 3. Undecided 4. Somewhat satisfied 5. Very much satisfied

    through study completion, an average of 9 months

  • Pain assessment

    Pain during the session will be assessed and graded as mild, moderate and severe

    through study completion, an average of 9 months

  • Dermoscopic evaluation

    Dermoscopy will be performed for each patient at baseline, during and after each follow-up visit to evaluate the improvement of: * Color (light brown, brown, dark brown) * Pigmentation (pseudo network and arcuate lesions) * Vascularity (present or absent telangiectasia)

    through study completion, an average of 9 months

Study Arms (2)

right side of the face

ACTIVE COMPARATOR

microneedling with tranexamic acid alone on the right side of the face

Drug: tranexamic acid microneedling

Left side of the face

ACTIVE COMPARATOR

microneedling with tranexamic acid combined with hyaluronic acid on the left side

Drug: Hyaluronic acid combined with tranexamic acid microneedling

Interventions

Hyaluronic acid combined with tranexamic acid microneedlingDRUG

1 ml of TXA, available as a 500 mg/5 ml ampoule, will be applied on the right side of the face after microneedeling and left to dry

Left side of the face
tranexamic acid microneedlingDRUG

On the left side of face, 0.5 ml of HA 3.5% will be used 1st followed by microneedling then 1 ml of TXA will be applied

right side of the face

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged \> 18 years.
  • Both sexes.
  • All types of melasma (epidermal, dermal and mixed).
  • Nearly bilateral symmetrical melasma

You may not qualify if:

  • Pregnancy and lactation
  • Patients who are taking contraceptive pills at the time of the study or during the past 12 months.
  • Patients with bleeding disorders with hypercoagulable state or the concomitant use of anticoagulants.
  • Patient with history of thrombosis like DVT, coronary artery disease, stroke.
  • Patient using any treatment for melasma during the past 1 month before the study.
  • Active skin infection.
  • Infection and immunosuppression
  • Patient with keloidal tendency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Melanosis

Condition Hierarchy (Ancestors)

HyperpigmentationPigmentation DisordersSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

February 17, 2023

First Posted

June 18, 2023

Study Start

June 1, 2023

Primary Completion

November 1, 2023

Study Completion

December 1, 2023

Last Updated

June 18, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will share