Evaluation of Laser and Tranexamic Acid in Treatment of Melasma

NCT04599205 | Unknown Phase 2

• 1 other identifier: EOFCLATAITOMCHAIS
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

Melasma Is an acquired, chronic, recurrent, symmetrical hypermelanosis, which is characterized by brown patches of variable darkness on sun exposed areas of the body. It is more common in women. It is common psychologically and emotionally distressing cosmetic problem in affected patients .

Conditions

Melasma

Outcome Measures

Primary Outcomes (1)

• safety and effectiveness of fractional CO2 laser, microneedling and topical tranexamic acid gel

  the therapeutic effect of combined fractional co2 laser and topical tranexamic acid versus either fractional co2 laser alone, topical TXA alone or combined microneedling and TXA in treatment of melasma.this will be assessed by melasma area and severity index (MASI).

  2 years

Secondary Outcomes (1)

• accurate outcome of each treatment modality

  2 years

Study Arms (3)

Microneedling group A

EXPERIMENTAL

Patients will be subjected to the following: Combined laser (power=3.6 mJ) and topical tranexamic acid (TXA) (one finger unit) gel on the right half of the face. Combined microneedling (by dermapen) and topical TXA gel only on the left half. Self application of topical TXA gel (2 finger units) on both sides on daily base.

Drug: Tranexamic acid

Laser group B

EXPERIMENTAL

Patients will be subjected to the following: Combined laser(power=3.6 mJ) and topical TXA gel (one finger unit) on the right half. Laser (power=3.6 mJ) only on the left one.

Drug: Tranexamic acid

Gel group C

EXPERIMENTAL

patients will be subjected to: Daily application of topical TXA gel (2 finger units) on both face sides.

Drug: Tranexamic acid

Interventions

Tranexamic acid DRUG

fractional co2 laser, microneedling and topical tranexamic acid gel

Also known as: laser, microneedling

Gel group C; Laser group B; Microneedling group A

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- Gender: Only female patients.
• Age: 18-50 years old.
• Type of melasma: Bilateral symmetrical facial melasma of all types.
• Fitzpatrick skin phototypes: Types III, IV and V.

You may not qualify if:

• \- Pregnancy and lactation.
• Patients taking oral contraceptive pills, hormonal replacement therapy or isotretinoin at the time of the study or during the past 6 months. Concomitant use of anticoagulants, bleeding disorders.
• Scarring and keloid tendency, active skin infections, active HSV, and those with facial cancer.
• History of photosensitivity or photosensitizing medications such as sulfonamides and tetracycline.
• Previous history of post inflammatory hyperpigmentation.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Melanosis

Interventions

Tranexamic Acid; Lasers; Percutaneous Collagen Induction

Condition Hierarchy (Ancestors)

Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Punctures; Rehabilitation

Study Officials

• EMAN R MOHAMED, MD

  assuit university hospital

  STUDY DIRECTOR

Central Study Contacts

aya H younis, MD

CONTACT

00201098898917; aya.h@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer

Study Record Dates

• First Submitted: September 9, 2020
• First Posted: October 22, 2020
• Study Start: December 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2022
• Last Updated: October 22, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share