Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06522984
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-15
Brief Title:
Fractional Erbium YAG Laser vs Intradermal and Systemic Tranexamic Acid
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Fractional Erbium YAG Laser vs Intradermal and Systemic Tranexamic Acid in Combination With Topical Hydroquinone for Refractory Melasma
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Melasma is a common acquired disorder of hyperpigmentaion caused by increased melanin production by melanocytes
Melasma is a name derived from the Greek word melas meaning blackIt is characterized by the appearance of brownish or grayish symmetrical patches on sun-exposed skin most commonly on the face Compared to men women are more likely to be affected
Melasma is a name derived from the Greek word melas meaning blackIt is characterized by the appearance of brownish or grayish symmetrical patches on sun-exposed skin most commonly on the face Compared to men women are more likely to be affected
Detailed Description:
Melasma is more common in people with dark complexions and Fitzpatrick skin types III IVDepending on ethnicity and region melasma prevalence might vary from 88 to 40 The cause of melasma is still unknown in the meantime
Numerous elements including genetics sunshine endocrine stimulation oxidative conditionspregnancy exogenous hormonsand morphofunctional changes may have a role in the development of the disease
Since melasma is a common skin condition affecting mostly pregnant women and those on hormonal birth control it is known as the mask of pregnancy
Treatment for melasma remains a challenge with substantial psychosocial ramifications Many factors including variability in clinical presentation and responsiveness to treatment between genders skin phototypes and ethnicities can affect treatment efficacy None of variety methods have been sufficiently effective to be considered the gold standard
Hydroquinone HQ has historically been the most studied topical agent in the treatment of melasma HQ is a hydroxyphenolic compound that inhibits the conversion of dopa to melanin by the inhibition of tyrosinase it also inhibits RNA and DNA synthesis of melanocytes and degrades melanosomes
Tranexamic acid TXA is an antifibrinolytic drug that has been used off-label for the treatment of melasma as an oral or intradermal injection
TXA is a lysine-derived amino acid with anti-inflammatory effects that prevents ultraviolet UV-induced skin pigmentation by inhibiting attachment of plasminogen to keratinocytes and activation of plasmin Plasmin stimulates melanogenesis by conversionof arachidonic acid to prostaglandin and leukotriene On the other hand plasmin increases the level of melanogenic factors
Laser therapy is a unique ablative modality that might potentially increase the penetration of medications applied topically by destroying the SC epidermal and dermal layers of the skin in a predictable and controlled manner
The Fractional erbiumdoped yttrium aluminum garnet Er YAG laser has a wavelength of 2940 nm and is strongly absorbed by water in the epidermis It exerts its ablation effect with minimal penetration depth and minimal heat generation and therefore minimal thermal damage
Numerous elements including genetics sunshine endocrine stimulation oxidative conditionspregnancy exogenous hormonsand morphofunctional changes may have a role in the development of the disease
Since melasma is a common skin condition affecting mostly pregnant women and those on hormonal birth control it is known as the mask of pregnancy
Treatment for melasma remains a challenge with substantial psychosocial ramifications Many factors including variability in clinical presentation and responsiveness to treatment between genders skin phototypes and ethnicities can affect treatment efficacy None of variety methods have been sufficiently effective to be considered the gold standard
Hydroquinone HQ has historically been the most studied topical agent in the treatment of melasma HQ is a hydroxyphenolic compound that inhibits the conversion of dopa to melanin by the inhibition of tyrosinase it also inhibits RNA and DNA synthesis of melanocytes and degrades melanosomes
Tranexamic acid TXA is an antifibrinolytic drug that has been used off-label for the treatment of melasma as an oral or intradermal injection
TXA is a lysine-derived amino acid with anti-inflammatory effects that prevents ultraviolet UV-induced skin pigmentation by inhibiting attachment of plasminogen to keratinocytes and activation of plasmin Plasmin stimulates melanogenesis by conversionof arachidonic acid to prostaglandin and leukotriene On the other hand plasmin increases the level of melanogenic factors
Laser therapy is a unique ablative modality that might potentially increase the penetration of medications applied topically by destroying the SC epidermal and dermal layers of the skin in a predictable and controlled manner
The Fractional erbiumdoped yttrium aluminum garnet Er YAG laser has a wavelength of 2940 nm and is strongly absorbed by water in the epidermis It exerts its ablation effect with minimal penetration depth and minimal heat generation and therefore minimal thermal damage
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None