Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06313307 |
| Other study ID # |
famotidine and melasma |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2023 |
| Est. completion date |
November 25, 2023 |
Study information
| Verified date |
March 2024 |
| Source |
Second Affiliated Hospital of Xi'an Jiaotong University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Melasma is a common hyperpigmented skin disorder presented with light to dark symmetrical
brown macules on face, malar and forehead areas in women with Fitzpatrick type III-IV.
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 cells1. As a result, melasma is often difficult to treat and is prone to
recurrence.
The pathophysiology of melasma is complex and has not been fully elucidated. Possible
pathogenesis of melasma includes ultraviolet (UV) exposure, genetic factors, sex hormones2,
chronic skin inflammation, skin barrier disfunction also contributes in the onset of
melasma1. Albeit melasma represents as melanin overproduction, multiple cell types are
implicated in the pathogenesis of melasma.
Mast cell number is increased in the dermis of melasma skin, especially in the areas with
solar elastosis3. Studies shown that the number of mast cells may be related to refractory
and recurrence of melasma treatment4. Though the role of mast cells in the development of
melasma remains unclear, based on the previous studies, among the bioactive mediators
released by mast cells, histamine plays a pivotal role in UV-induced activation of
melanocytes5. There are 4 subtypes of histamine receptors (HR1-4)6. Among the 4 subtypes of
HRs, histamine stimulates melanocyte activation through H2 receptors on melanocytes7.The
function of H2R activation has been verified in vivo by a UV-induced pigmentation in guinea
pig5. Some therapeutic drugs for melasma such as tranexamic acid, corticosteroids and
calcineurin inhibitors can inhibit the recruitment and maturation of mast cell by inhibiting
mast cell proliferation3. These drugs inhibit melanocyte activation by reducing inflammation
in melasma skin, while H2 receptor antagonists (H2RA) suppress pigmentation by inhibiting
histamine-mediated melanogenesis and dendricity rather than preventing the inflammation
induction. Thus, H2- blockers such as famotidine as a potential treatment strategy for
melasma should be valued. The latest clinical trials have shown possible benefits of the oral
H2-blocker famotidine combined with H1-blocker ketotifen for melasma8. This report provides
more evidence for the efficacy of H2RA famotidine in melasma. However, the function of
famotidine should be evaluated. Moreover, topical administration of famotidine may offer
greater benefits than oral medication, but the effect should be evaluated further.
Lasers and light-based devices such as low-fluence Q-switched 1064-nm Nd:YAG laser have been
considered as an effective modality for the treatment of melasma by directly targeting
melanosome9,10. The non-ablative 1927 nm fractional thulium fiber laser targets water instead
of melanocytes and conferring greater ability to target superficial layers of the skin11,
thus has less risk of PIH than melanosome targeting lasers. Also, the fractional laser
induced microscopic treatment zones (MTZs) can promote local drug absorption and
bioavailability while reducing the undesirable effects associated with systemic absorption.12
In the present study, The investigators attempted to verified role of H2R inhibitor in the
treatment of melasma by combining famotidine with 1927nm fractional laser-assisted drug
delivery13. 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.
