Ignite Creation Date:
2024-05-06 @ 7:07 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05909072
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-06-18
First Post:
2023-02-17
Brief Title:
Tranexamic Acid With Microneedling in Melasma
Sponsor:
Zagazig University
Organization:
Zagazig University
Study Overview
Official Title:
The Boosting Effect of Hyaluronic Acid on Tranexamic Acid Microneedles in Melasma Patients A Split- Face Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Topical tranexamic a hydrophilic molecule cant pass the lipid barriers of the stratum corneum and its also not retained in adequate amount in the epidermis to enter the melanocytes so theres a difficulty in the effective delivery of tranexamic acid into the melanocytes
Hyaluronic acid was proved to improve the effective delivery of tranexamic acid through loosening corneocyte packing and helping TXA entering the melanocytes and minimizing its epidermal diffusion
Hyaluronic acid was proved to improve the effective delivery of tranexamic acid through loosening corneocyte packing and helping TXA entering the melanocytes and minimizing its epidermal diffusion
Detailed Description:
Melasma is a common acquired pigmentary disorder characterized by irregular symmetric medium- to dark-brown macules and patches affecting the photoexposed areas of the face causing cosmetic disfigurement and low quality of life of the patient Melsama affects mostly women of reproductive age with Fitzpatrick skin type IV-VI
The exact pathogenesis of melasma isnt well-known however the major etiological factors include genetic influences chronic sun exposure pregnancy contraceptives drugs and hormone therapy Although the exact pathogenesis of melasma is not fully clarified the pathophysiology of melasma is believed to involve excess production of melanin or an increase in the activity of melanocytes in the skin
Melasma is often refractory to treatment with common relapses so it needs a treatment modality that can be used for long time with minimal side effects Topical depigmenting agents have good results but also may lead to many side effects
Microneedling is a minimally invasive technique used for skin rejuvenation and treatment of many diseases such as dyspigmentation Gentle microneedling enhances upper dermal changes and increases the epidermal turnover that leads to decreasing melanin production and its deposition in melanocytes and also increasing the epidermal melanin cleareance which improve melasma
Microneedling enhances transdermal drug delivery across the skin barrier through creating microchannels into the skin without causing actual epidermal damage Microneedling with topical tranexamic acid TXA was proved to be safe effective and comparatively painless without any detectable side effects
Tranexamic acid a hemostatic drug is used to treat melasma by inhibiting the plasminogen activating system The intracellular release of arachidonic acid a precursor to prostaglandins E2 and the level of alpha-melanocyte-stimulating hormone increase as the result of plasmin activity These two substances can activate melanogenesis Therefore the anti-plasmin activity of TA is thought as the main mechanism of hypopigmentory effect of this agent
Tranexamic acid also inhibits angiogenesis of dermal blood vessels through suppression of vascular endothelial growth factor
Topical tranexamic a hydrophilic molecule cant pass the lipid barriers of the stratum corneum and its also not retained in adequate amount in the epidermis to enter the melanocytes so theres a difficulty in the effective delivery of tranexamic acid into the melanocytes
Hyaluronic acid HA was proved to improve the effective delivery of tranexamic acid through loosening corneocyte packing and helping TXA entering the melanocytes and minimizing its epidermal diffusion
Hyaluronic acid also can actively adhere to melanocytes using cell suface HA receptors such as cd44 so promotes the targeted delivery to melanocytes
The exact pathogenesis of melasma isnt well-known however the major etiological factors include genetic influences chronic sun exposure pregnancy contraceptives drugs and hormone therapy Although the exact pathogenesis of melasma is not fully clarified the pathophysiology of melasma is believed to involve excess production of melanin or an increase in the activity of melanocytes in the skin
Melasma is often refractory to treatment with common relapses so it needs a treatment modality that can be used for long time with minimal side effects Topical depigmenting agents have good results but also may lead to many side effects
Microneedling is a minimally invasive technique used for skin rejuvenation and treatment of many diseases such as dyspigmentation Gentle microneedling enhances upper dermal changes and increases the epidermal turnover that leads to decreasing melanin production and its deposition in melanocytes and also increasing the epidermal melanin cleareance which improve melasma
Microneedling enhances transdermal drug delivery across the skin barrier through creating microchannels into the skin without causing actual epidermal damage Microneedling with topical tranexamic acid TXA was proved to be safe effective and comparatively painless without any detectable side effects
Tranexamic acid a hemostatic drug is used to treat melasma by inhibiting the plasminogen activating system The intracellular release of arachidonic acid a precursor to prostaglandins E2 and the level of alpha-melanocyte-stimulating hormone increase as the result of plasmin activity These two substances can activate melanogenesis Therefore the anti-plasmin activity of TA is thought as the main mechanism of hypopigmentory effect of this agent
Tranexamic acid also inhibits angiogenesis of dermal blood vessels through suppression of vascular endothelial growth factor
Topical tranexamic a hydrophilic molecule cant pass the lipid barriers of the stratum corneum and its also not retained in adequate amount in the epidermis to enter the melanocytes so theres a difficulty in the effective delivery of tranexamic acid into the melanocytes
Hyaluronic acid HA was proved to improve the effective delivery of tranexamic acid through loosening corneocyte packing and helping TXA entering the melanocytes and minimizing its epidermal diffusion
Hyaluronic acid also can actively adhere to melanocytes using cell suface HA receptors such as cd44 so promotes the targeted delivery to melanocytes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None