Tranexamic Acid vs Fractional CO2 Laser in Post-acne Hyperpigmentation

NCT ID: NCT03765021

Last Updated: 2018-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-31

Study Completion Date

2019-07-31

Brief Summary

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comparing between the effect of intradermal injection of TXA and low power low density fractional CO2 lasers on post acne hyperpigmentation

Detailed Description

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Randomized controlled split-face study. One side of the face will be assigned to TXA intradermal microinjection using Kapron 500mg/5ml ampoules (Amoun Pharmaceutical Company), the dose of 1 ml syringe with 100mg/ml. TXA will be prepared under sterile conditions. Injections will be applied intradermally on hyperpigmented areas at 1cm intervals. The injection will be repeated every two weeks for three months. The other side of the face will be randomly assigned to low power fractional CO2 laser with a power of 12 watts, spacing 700 micrometers (low density), and dwell time 300 microsecond every four weeks for three months.

Conditions

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Post Inflammatory Hyperpigmentation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
Method of randomization: using closed envelopes containing cards with fractional CO2 Rt and fractional CO2 Lt and the patient will draw one of them blindly.

Study Groups

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Tranexamic acid injection (Kapron)

One side of the face will be assigned to TXA intradermal microinjection using Kapron 500mg/5ml ampoules (Amoun Pharmaceutical Company), the dose of 1 ml syringe with 100mg/ml. TXA will be prepared under sterile conditions. Injections will be applied intradermally on hyperpigmented areas at 1cm intervals. The injection will be repeated every two weeks for three months.

Group Type EXPERIMENTAL

Tranexamic Acid

Intervention Type DRUG

One side of the face will be assigned to TXA intradermal microinjection 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 hyperpigmented areas at 1cm intervals. The injection will be repeated every two weeks for three months.

Fractional CO2 laser resurfacing

The other side of the face will be randomly assigned to do low power fractional CO2 laser with a power of 12 watts, spacing 700 micrometers (low density), and dwell time 300 microsecond every four weeks for three months.

Group Type ACTIVE_COMPARATOR

Fractional CO2 laser

Intervention Type DEVICE

The other side of the face will be randomly assigned to low power fractional CO2 laser with a power of 12 watts, spacing 700 micrometers (low density), and dwell time 300 microsecond every four weeks for three months.

Interventions

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Tranexamic Acid

One side of the face will be assigned to TXA intradermal microinjection 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 hyperpigmented areas at 1cm intervals. The injection will be repeated every two weeks for three months.

Intervention Type DRUG

Fractional CO2 laser

The other side of the face will be randomly assigned to low power fractional CO2 laser with a power of 12 watts, spacing 700 micrometers (low density), and dwell time 300 microsecond every four weeks for three months.

Intervention Type DEVICE

Other Intervention Names

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Kapron

Eligibility Criteria

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Inclusion Criteria

* Egyptians of both sexes.
* Age \> 18.
* Patients who can avoid sun exposure one week after sessions.
* Patients who stopped taking systemic isotretinoin for more than six months.

Exclusion Criteria

* Pregnancy and lactation.
* Concomitant use of anticoagulants.
* Bleeding disorders.
* Personal or family history of DVT or thromboembolic events.
* Scarring and keloid tendency.
* Active skin infection, active HSV.
* History of photosensitivity or photosensitizing medication.
* Occupational sun exposure.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Maha Fathy Elmasry

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Tawfic SO, Abdel Hay R, Salim H, Elmasry MF. Tranexamic acid versus fractional carbon dioxide laser in post-acne hyperpigmentation. Dermatol Ther. 2021 Nov;34(6):e15103. doi: 10.1111/dth.15103. Epub 2021 Sep 6.

Reference Type DERIVED
PMID: 34414642 (View on PubMed)

Other Identifiers

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Dermatology 9

Identifier Type: -

Identifier Source: org_study_id

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