A study to assess the effectiveness of the G-Lite® cream with Cristello® sunscreen for hyperpigmentation
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Effect assessed in terms of reduction in epidermal pigmentation assessed clinically, dermoscopically and by using Fotofinder.
研究概览
简要总结
Pigmentation disorders can be an issue for all individuals, especially those with skin of color. Although the natural pigmentation in patients with skin of color provides many advantages such as sun protection and slowed signs of aging, it also increases susceptibility to hyperpigmentation, which can have a negative psychological impact. Both physicians and dermatology patients are searching for long-term topical skin care solutions (both cosmetic and cosmeceutical) to address problems presented by skin hyperpigmentation.
Traditional depigmenting agents, although highly effective, can raise several safety concerns (for example, ochronosis, atrophy, carcinogenesis, and other local or systemic side effects) with long-term exposure. Active compounds isolated from plants, such as arbutin, aloesin, gentisic acid, flavonoids, hesperidin, licorice, niacinamide, yeast derivatives, and polyphenols, inhibit melanogenesis without melanocytotoxicity by different mechanisms.
Artocarpusextract is derived from the dried Artocarpus lakoocha heartwood with the major being Oxyresveratrol.It has depigmenting effect by non-competitive inhibition of tyrosinase activity with safety profiles and available at low cost**. Arbutin and Deoxyarbutin** are botanicals that are structurally similar to HQ. Arbutin, causes decreased tyrosinase activity without affecting messenger RNA expression, while also inhibiting melanosome maturation without being toxic to melanocytes. Kojic acid is a hydrophilic molecule derived from species of Aspergillus and Penicillium, acting as a tyrosinase inhibitor that chelates copper at the enzyme’s active site. Licorice extracts are skin-lightening agents with the fewest side effects. Because of its benign profile, liquorice extract is one of the most widely used agents in cosmeceuticals for skin brightening. It inhibits tyrosinase, leading to inhibition of melanogenesis. Licorice extract also has topical anti-inflammatory and anticarcinogenic properties. Niacinamide is physiologically active amide of niacin. It has a beneficial effect on skin which includes reduction in cutaneous pigmentation by inhibition of melanosome transfer to keratinocytes, anti-inflammatory action, prevention of photo carcinogenesis and production of ceramides which enhances epidermal permeability barrier function. Alpha-Tocopherol (Vitamin E) is a lipophilic antioxidant derived from cereals, nuts, vegetable oils in human body. It has a major role in scavenging free radicals and the depigmented effect can be attributed to its inhibitory action on tyrosinase and increase in intracellular glutathione. Mulberry extract is derived from the leaves of Morbus alba L, which has anti-hyperglycaemic activity. The skin lightening effect of mulberry extract is due to its inhibition of dopa oxidase activity of tyrosinase and free radical scavenger. Hyaluronic acid specifically makes up the extracellular matrix of skin which has a unique property of hydrating the skin and has an anti-ageing effect. Octinoxate is a cinnamate ester, organic sunscreen which mainly filters UVB rays.
Pigment lightening is an integral component of dermatologic therapy, and there are many safe treatments with varying degrees of efficacy that can be employed. Adding sunscreen to the treatment regimen and patient education regarding sun protection measures also will be beneficial in the management of patients with pigmentation. The management of hyperpigmentation can be challenging,
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)(—)
- 性别
- All
入选标准
- •1.Female and male patients, from 18-45 years of age with hyperpigmentation 2.Participants who are willing to provide a written informed consent and photo consent form 3.Participants who are willing to follow up for three visits over a period of 12 weeks (approximately).
- •4.Participants who are able and willing to follow all the study procedures including abstinence from usage of any OTC product related to face applications.
- •5.Participants who are willing to be clinically photographed as per protocol.
排除标准
- •1.Patient who is not willing to participate in the study.
- •2.Patients who are using other pigment reduction creams.
- •(Except sunscreen, a base moisturiser) 3.Subjects with other dermatological disorder of the face that may interfere with the study evaluation (Acne, DPN, Seborrheic melanosis) 4.Subjects with known hypersensitivity to any of the study drugs or constituents.
- •5.Subjects who are expected to be exposed to the triggering factors.
- •(Excessive sun exposure, UVB photo therapy, use of OCPs) 6.Patient who has received facial procedures like dermabrasion, chemical peels or laser procedures within the last 1 month.
- •7.Any patient as per investigator’s opinion is unfit for participation in the study.
- •8.Pregnant / lactating females.
结局指标
主要结局
Effect assessed in terms of reduction in epidermal pigmentation assessed clinically, dermoscopically and by using Fotofinder.
时间窗: After 3 months
次要结局
- To assess the effect of G-lite on reduction of hyperpigmentation by using Dermacatch, clinical assessment, Dermoscopic & photographic assessment baseline visit (visit1, Day 0). They will be followed on Visit 2, (6th week) and Visit 3, (12th week).(After 3 Months)
研究者
Dr B S Chandrashekar
CUTIS Academy of Cutaneous Sciences
