Fractional co2 Laser Followed by Either Vitamin c or Tranexamic Acid in Treatment of Melasma.

NCT ID: NCT05911698

Last Updated: 2023-08-15

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

2023-10-28

Study Completion Date

2024-03-31

Brief Summary

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The aim of the study:

1.To compare the efficacy and safety of fractional CO2 laser in combination with vitamin c and tranexamic acid in the treatment of melasma.

2 .To assess the value of dermoscope in measuring of the response to treatment in melasma patients compared to clinical scoring.

Detailed Description

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Melasma is a chronic dermatologic condition defined by hyperpigmented macules and patches that appear in areas of sun exposure .

Traditionally, the mainstays of treatment for melasma have been topical bleaching agents and strict photoprotection.

Additional adjuvant treatment modalities include chemical peels, dermabrasion, and laser treatments, all of which have demonstrated limited efficacy. There has been an interest in studying the effects of vitamin c and tranexamic acid in melasma.

The development of fractional resurfacing has led to improvements to melasma treatment with decreased incidence of post-inflammatory hyperpigmentation; these improvements are due to the enhanced healing times and decreased inflammation as a result of the formation of microscopic columns of tissue destruction.

These microscopic columns of damaged tissue are surrounded by areas of normal tissue, allowing for shorter migratory paths for the healing keratinocytes.

Conditions

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Melasma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patients with all types of melasma

Fractional ablative CO2 laser : For each patient, Right side of the face : Fractional ablative CO2 laser will be followed by immediate topical application of vitamin c 3% .

Left side of the face: Fractional ablative CO2 laser will be followed by immediate topical application of tranexamic acid.

* Fractional ablative CO2 laser sessions will be performed using the following parameters: power 8-10 W(according to the skin type), spacing 1000 μm (5.3% density), dwell time 400 μs, and stack .
* During the session, protective goggles will be used both by the patient and by the physician.

Group Type OTHER

Fractional co2 laser

Intervention Type DEVICE

The development of fractional resurfacing has led to improvements to melasma treatment with decreased incidence of post-inflammatory hyperpigmentation; these improvements are due to the enhanced healing times and decreased inflammation as a result of the formation of microscopic columns of tissue destruction.

These microscopic columns of damaged tissue are surrounded by areas of normal tissue, allowing for shorter migratory paths for the healing keratinocytes.

Interventions

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Fractional co2 laser

The development of fractional resurfacing has led to improvements to melasma treatment with decreased incidence of post-inflammatory hyperpigmentation; these improvements are due to the enhanced healing times and decreased inflammation as a result of the formation of microscopic columns of tissue destruction.

These microscopic columns of damaged tissue are surrounded by areas of normal tissue, allowing for shorter migratory paths for the healing keratinocytes.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. All types of melasma (epidermal, dermal, and mixed) will be included .
2. Patients older than 19 years of age.

Exclusion Criteria

1. Pregnancy, breastfeeding.
2. Patients taking drugs that induce facial pigmentation e.g, oral contraceptive pills, or hormonal replacement therapy at the time of the study or during the past 12 months.
3. Patients using of any topical bleaching within 1 month before recruitment.
4. Employment of chemical peels or laser therapy during the past 6 months.
5. Concomitant use of anticoagulants, bleeding disorders.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Khadija Qenawi

OTHER

Sponsor Role lead

Responsible Party

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Khadija Qenawi

Doctor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Khadija Qenawi, Doctor

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Hanan Ahmed, Professor

Role: STUDY_DIRECTOR

Assiut University

Reham Maher, Professor

Role: STUDY_DIRECTOR

Assiut University

Central Contacts

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Khadija Qenawi, Doctor

Role: CONTACT

+201140109931

References

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Neeley MR, Pearce FB, Collawn SS. Successful treatment of malar dermal melasma with a fractional ablative CO(2) laser in a patient with type V skin. J Cosmet Laser Ther. 2010 Dec;12(6):258-60. doi: 10.3109/14764172.2010.538412.

Reference Type BACKGROUND
PMID: 21142733 (View on PubMed)

Jalaly NY, Valizadeh N, Barikbin B, Yousefi M. Low-power fractional CO(2) laser versus low-fluence Q-switch 1,064 nm Nd:YAG laser for treatment of melasma: a randomized, controlled, split-face study. Am J Clin Dermatol. 2014 Aug;15(4):357-63. doi: 10.1007/s40257-014-0080-x.

Reference Type BACKGROUND
PMID: 24858737 (View on PubMed)

Lai D, Zhou S, Cheng S, Liu H, Cui Y. Laser therapy in the treatment of melasma: a systematic review and meta-analysis. Lasers Med Sci. 2022 Jun;37(4):2099-2110. doi: 10.1007/s10103-022-03514-2. Epub 2022 Feb 5.

Reference Type BACKGROUND
PMID: 35122202 (View on PubMed)

Other Identifiers

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Fractional laser in melasma

Identifier Type: -

Identifier Source: org_study_id

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