Clinical trial NCT05911698: Fractional co2 Laser Followed by Either Vitamin c or Tranexamic Acid in Treatment of Melasma.
Official title: Fractional co2 Laser Followed by Either Vitamin c or Tranexamic Acid in Treatment of Melasma. Asplit Face Dermoscopic and Clinical Study.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Melasma
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-06-22
Enrollment: 25
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Efficacy and safety of fractional CO2 laser in treatment of melasma.
timeFrame: 1year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Khadija Qenawi, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Assiut University
name: Hanan Ahmed, Professor
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Reham Maher, Professor
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.