Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2026-01-01 @ 6:38 PM
Study NCT ID:
NCT03472235
Status:
UNKNOWN
Last Update Posted:
2018-03-21
First Post:
2018-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Microneedle and Trichloroaceticacid in Treatment of Melasma
Sponsor:
Assiut University
Organization:
Study Overview
Official Title:
Combined Trichlotoaceticacid and Microneedle Versus Trichlroacetic Acid Alone in the Treatment of Melasma
Status:
UNKNOWN
Status Verified Date:
2018-02
Last Known Status:
NOT_YET_RECRUITING
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:
Melasma is an acquired disorder of hyperpigmentation characterised by blotchy, light-to-dark brown macules distributed symmetrically on the sun-exposed parts of the body.
Although many factors have been proposed to have a role in pathogenesis, the exact ethology is yet to be understood. The most commonly identifiable risk factors include ultraviolet radiation, genetic predisposition, pregnancy, oral contraceptives, thyroid disease and drugs like antiepileptic. The excessive pigmentation has been attributed to both melanocytosis (increased number of melanocytes) as well as melano genesis (excess production of melanin) as confirmed in a histopathological study on Asian patients.\] Furthermore, a vascular component has also been proposed to play a role in the pathogenesis of melisma. Kim et al. have found that lesion melasma skin had greater expression of the vascular endothelial growth factor in keratinocytes compared to nearby nonlesional skin.
Although many factors have been proposed to have a role in pathogenesis, the exact ethology is yet to be understood. The most commonly identifiable risk factors include ultraviolet radiation, genetic predisposition, pregnancy, oral contraceptives, thyroid disease and drugs like antiepileptic. The excessive pigmentation has been attributed to both melanocytosis (increased number of melanocytes) as well as melano genesis (excess production of melanin) as confirmed in a histopathological study on Asian patients.\] Furthermore, a vascular component has also been proposed to play a role in the pathogenesis of melisma. Kim et al. have found that lesion melasma skin had greater expression of the vascular endothelial growth factor in keratinocytes compared to nearby nonlesional skin.
Detailed Description:
As regards management, the therapeutic options range from photoprotection, topical hypopigmenting agents, chemical peels and lasers. There are variety of less-tried systemic agents like fish oil, green tea and . Although no single agent has proved to be effective for all patients, a combination of two or three agents is often tried to achieve optimum results.
Chemical peeling is the application of a chemical agent to the skin, which causes the controlled destruction of a part or of the entire epidermis, with or without the dermis, leading to exfoliation and removal of superficial lesions, followed by the regeneration of new epidermal and dermal tissues.
Chemical peels are a well-known modality of treatment for melasma. The basic mechanism of the action of chemical peels in melasma is the removal of unwanted melanin by causing a controlled chemical burn to the skin.
Trichlroacetic acid peeling has been the gold standard in chemical peeling for many decades.
For superficial peels Trichlroacetic acid 10% to 25% are used. some authors consider up to 35% Trichlroacetic acid as also a superficial.
Skin microneedling is a technique predominantly used to improve the appearance of cutaneous scarring and photo damage.
Fine needles puncture the skin, resulting in increased dermal elastin and collagen, collagen remodelling, and thickening of the epidermis and dermis. Additionally, skin needling creates small channels, which increase the absorption of topically applied preparations A property which has been used in various dermatological treatments.
Chemical peeling is the application of a chemical agent to the skin, which causes the controlled destruction of a part or of the entire epidermis, with or without the dermis, leading to exfoliation and removal of superficial lesions, followed by the regeneration of new epidermal and dermal tissues.
Chemical peels are a well-known modality of treatment for melasma. The basic mechanism of the action of chemical peels in melasma is the removal of unwanted melanin by causing a controlled chemical burn to the skin.
Trichlroacetic acid peeling has been the gold standard in chemical peeling for many decades.
For superficial peels Trichlroacetic acid 10% to 25% are used. some authors consider up to 35% Trichlroacetic acid as also a superficial.
Skin microneedling is a technique predominantly used to improve the appearance of cutaneous scarring and photo damage.
Fine needles puncture the skin, resulting in increased dermal elastin and collagen, collagen remodelling, and thickening of the epidermis and dermis. Additionally, skin needling creates small channels, which increase the absorption of topically applied preparations A property which has been used in various dermatological treatments.
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?: