The Efficacy in Treatment of Facial Melasma Combined With Thulium 1927-nm Fractional Laser and Topical H2R Antagonist

NCT06313307 | Completed DMC

• 1 other identifier: famotidine and melasma
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Melasma is a hyperpigmentary disorder of the skin especially of the face. Compared with normal skin, histologic features of melasma include the enhanced activity of melanocytes, higher solar elastosis in upper dermis, basement membrane disruption which promotes melanocytes and melanin into the dermis, increased vascularization, and an increased number of mast cells. 1927nm fractional laser was approved to treat melasma with no major side effects, however,hyperpigmentation and recurrence occasionally happened after laser therapy. Mast cells may paly a key role in the refractory melasma and hyperpigmentation. We hypothesized that laser treatment may stimulate the activation of pre-existing mast cell in melasma skin and promote mast cell proliferation and degranulation to release mediators such as histamine (HA). HA has been demonstrated to increase the melanin content and tyrosinase activity of melanocytes and induce melanogenesis and morphological changes by activating cAMP-PKA pathway through H2 receptors on melanocytes5. H2R antagonist(H2RA) can suppress pigmentation by reducing the increase of activated melanocytes by UVB irradiation. In the present study, the investigators speculated that H2RA can enhance the efficacy of laser treatment of melasma and block the histamine-mediated melanogenesis and dendricity to prevent postoperative hyperpigmentation. The investigators combined 1927nm fractional laser with topical famotidine for melasma as a new therapeutic strategy to treat melasma.The investigators performed a split-face, single-blinded study to evaluate the efficacy and safety of 1927nm fractional laser with topical famotidine for the treatment of facial melasma.

Conditions

Melasma

Outcome Measures

Primary Outcomes (1)

• Modified Melasma Area Severity Score（mMASI）

  Minimum 0 points, maximum 7.2 points. The higher the score, the more severe the lesions

  week0，4，8，12，16

Secondary Outcomes (2)

• melanin index（MI）

  week0，4，8，12，16

• erythema index(EI)

  week0，4，8，12，16

Other Outcomes (1)

• Melasma Quality of Life Index(MELASQoL)

  week 0 and week 16

Study Arms (2)

Thulium 1927nm fractional laser

ACTIVE COMPARATOR

1927nm fractional laser (South Korea, WONTECH, Lavieen) was performed with 4-week interval (Week 0, 4, 8, 12 and 16) for a total of 4 treatments. The parameter of 1927nm fractional laser was as follows: duration 600-800um, 10w, density 0.8mm, 1 pass.

Device: Thulium 1927-nm Fractional Laser

Thulium 1927nm fractional laser and topical H2R antagonist

EXPERIMENTAL

Topical H2RA (2% famotidine solution solved in double-distilled water (containing poloxamer 407, glycerol, lauryl alcohol polyether-4, polyethylene glycol-8, and propylene glycol)) was applied immediately after the laser therapy and then topically twice per day in the morning and the evening for 16 weeks.

Combination Product: topical H2R antagonist; Device: Thulium 1927-nm Fractional Laser

Interventions

topical H2R antagonist COMBINATION_PRODUCT

Topical H2RA (2% famotidine solution solved in double-distilled water (containing poloxamer 407, glycerol, lauryl alcohol polyether-4, polyethylene glycol-8, and propylene glycol)) was applied topically twice per day in the morning and the evening for 16 weeks.

Thulium 1927nm fractional laser and topical H2R antagonist

Thulium 1927-nm Fractional Laser DEVICE

1927nm fractional laser (South Korea, WONTECH, Lavieen) was performed with 4-week interval (Week 0, 4, 8, 12 and 16) for a total of 4 treatments. The parameter of 1927nm fractional laser was as follows: duration 600-800um, 10w, density 0.8mm, 1 pass.

Thulium 1927nm fractional laser; Thulium 1927nm fractional laser and topical H2R antagonist

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with symmetrical melasma on both sides of the face were included

You may not qualify if:

• allergic to the famotidine;
• pregnant or lactating
• received other treatment for melasma in the last 1 month
• taking contraceptive pills for a long time
• with skin cancer, systemic diseases or mental illness
• patients with active inflammation or viral infection on the face
• patients with a history of facial injections or surgery in the 2 months prior to the test
• patients with immunodeficiency diseases
• patients with the need to work outdoors for long periods of time and who are unable to protect themselves from the sun.

Sponsors & Collaborators

• Second Affiliated Hospital of Xi'an Jiaotong University: lead

Study Sites (1)

The second affiliated hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710000, China

Location

MeSH Terms

Conditions

Melanosis

Condition Hierarchy (Ancestors)

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

Study Officials

• ZHAO WANG

  The second affiliated hospital of Xian Jiaotong University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 29, 2024
• First Posted: March 15, 2024
• Study Start: April 1, 2023
• Primary Completion: November 25, 2023
• Study Completion: November 25, 2023
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)