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Melanosis clinical trials

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NCT ID: NCT06313307 Completed - Melasma Clinical Trials

The Efficacy in Treatment of Facial Melasma Combined With Thulium 1927-nm Fractional Laser and Topical H2R Antagonist

Start date: April 1, 2023
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT05969587 Completed - Melasma Clinical Trials

Cysteamine Compared to Hydroquinone in Melasma

Start date: November 28, 2019
Phase: Phase 3
Study type: Interventional

Melasma is an acquired pigmentary disorder of symmetrical hyperpigmentation appearing as variable darkness macules and patches over the forehead, cheeks, and chin, even sun-exposed areas of the body. Melasma is predominantly affects women but men can also be affected. Melasma is commonly seen in Asia, where patients with Fitzpatrick skin types III and IV, and areas of high ultraviolet radiation. It is challenging and difficult to treat melasma for its refractory and recurrent nature. There is a variety of therapeutic approaches include topical medication with Kligman's formula, oral medication, chemical peels, lasers, and light therapy. Cysteamine (b-mercaptoethylamine) hydrochloride is the stable amino-thiol that acts as an antioxidant. It can be naturally produced in the human body and is a degrada-tion product of the amino acid L-cysteine. It has been known to be a potent depigmenting agent for about five decades. The mechanism of cysteamine for depimentation is not through melanotoxicity, which is the major depigmentation mechanism of hydro-quinone. Exogenous ochronsis is the major concern about the long-term use of hydro-quinone. Cysteamine is a thiolic compound that inhibit tyrosinase and peroxidase activity of melanocytes and produce notably greater amounts of pheomelanin but less eumelanin. In addition, thiols can act as a chelating agent of iron and copper ions Fenton reaction during pigment synthesis. Thols can also scavenge dopaquinone and deplete dopaquinone from the melanogenesis pathway. Then, higher levels of intra-cellular glutathione augmented by cysteamine cause the melanogenesis to proceed at a slower rate by shifting eumelanogenesis to pheomelanin synthesis. Since new technology permits reduction of the sulfur-odour of cysteamine hydro-chloride, cysteamine 5% cream permit the use in topical depigmenting preparations. Considerable efficacy and safety of cysteamine 5% cream in the treatment of epidermal melasma were confirmed by comprehensive measurements in previous well-controlled studies. However, the depigmenting efficacy of cysteamine compared with hydroquinone has never been evaluated. In addition, durability of the depigmenting efficacy has never been reported and the maintenance usage the cysteamine 5% cream has never yet been studied. In the present study, the investigators evaluate the efficacy of cysteamine 5% cream with hy-droquinone 4% cream in treating melasma and provide the maintenance regimen of cys-teamine 5% cream for Asian patients with melasma.

NCT ID: NCT05887219 Completed - Melasma Clinical Trials

Comparison of Azelaic Acid 20 % Cream Versus Hydroquinone 4% Cream as an Adjuvant to Oral Tranexamic Acid in Melasma

Start date: November 1, 2022
Phase: Phase 1
Study type: Interventional

Methodology: Fifty female patients presented with melasma (symmetrically distributed hyperpigmented macules and patches on the face) diagnosed by consultant dermatologist on clinical presentation were included in this study. The sample size was calculated by WHO Sample Size calculator taking 31% proportion of excellent response with 4% hydroquinone as an adjuvant to oral tranexamic acid as compared to 2.25% proportion of excellent response with 20% azelaic acid, 80% power of test and 5% significance level. After randomization, patients were divided into two groups. Group A was managed with 4% hydroquinone cream as an adjuvant to oral tranexamic acid (250 mg twice daily) while group B was managed with topical 20% azelaic acid (daily at night) for six months. Clinical evaluation was done initially at the start of therapy and then at 2nd, 4th and 6th month using MASI score and patient's response. Efficacy was assessed in both groups at the end of therapy after six months.

NCT ID: NCT05884151 Completed - Melasma Clinical Trials

Comparison of Intralesional Tranexamic Acid and Platelets Rich Plasma in the Treatment of Melasma

Start date: November 1, 2022
Phase: Phase 1
Study type: Interventional

ABSTRACT Objective: To study the efficacy while comparing Intralesional tranexamic acid Vs Platelets rich plasma (PRP) in treatment of Melasma. Study design: Randomized-controlled trial (RCT). Study setting and duration: Dept of dermatology, CMH-Abbottabad, Nov-2022 /April-2023. Methodology: The sample size of 60 patients 20 to 40 years were calculated by using Openepi App. The informed consent was taken. The patients were randomly allocated to two groups: Group A (30 patients injected with Intradermal Tranexamic acid (4mg/ml) and Group B (30 patients treated with PRP (1ml) intra-dermally, every fourth week for up to 12 weeks between both groups). The mMASI scale was used to evaluate all patients. The final evaluation was performed on the 24th week of follow-up. For analysis Statistical Package for the social sciences version-27 was used. To determine statistical significance a paired t-samples test with a p-value of < 0.05 was applied.

NCT ID: NCT05864417 Completed - Healthy Clinical Trials

A Study to Assess Effect of Two Facial Sunscreens in Improving Wrinkles, Fine Lines and Melasma in Adult Participants

Start date: March 22, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the topical safety (tolerability/acceptability) and efficacy of two facial sunscreen in improving wrinkles, fine lines and melasma after 84 +/- 2 days of use under normal conditions on the face by adult participants. For these investigational products, safety parameters, clinical efficacy, instrumental efficacy (assessment of color intensity and size of melasma spots and assessment of wrinkles and fine lines), facial imaging, and self-perceived efficacy through subjective questionnaire and quality of life questionnaires (MELASQol) will be evaluated, as well as an open emotional statement written by the participant at the end of use experience".

NCT ID: NCT05790577 Completed - Melasma Clinical Trials

Comparison of 30% Metformin and 2% Nicotinamide Lotion With Kligman Formula in the Treatment of Melasma

Start date: February 1, 2022
Phase: Phase 2
Study type: Interventional

Comparison of 30% Metformin and 2% Nicotinamide lotion with kligman formula in the treatment of Melasma

NCT ID: NCT05698342 Completed - Melasma Clinical Trials

Tissue-resident Memory T Cells Expression in Melasma

Start date: July 1, 2021
Phase:
Study type: Observational

The treatment of melasma and the maintenance of depigmentation represent a challenge due to its frequent recurrences. Pathophysiological mechanisms and factors have been linked to melasma such as inflammation, sun exposure, increased CD4+ T lymphocytic infiltrate and IL-17 in damaged skin. Tissue-resident memory T cells (Trm), derived from naïve T lymphocytes, are associated with the recurrence of lesions at the same sites but they have not been described in melasma. This a Cross-sectional, prospective analytical study. 20 female patients, 18 to 55 years of age, with diagnosis of melasma and mMASI score of at least 7, at least 1-year duration, lesional and perilesional skin biopsies were taken for PCR and DIF. The objective is to determine the transcription factors of Trm cells in malar melasma.

NCT ID: NCT05362500 Completed - Melasma Clinical Trials

Comparison of Chemical Peeling Agent With Transamine for Treatment of Melasma

Start date: June 1, 2021
Phase: Phase 1
Study type: Interventional

Melasma is an acquired skin disorder characterized by hyper-melanosis. Melasma is a term that originates from the Greek root "melas" (black color) and was formerly known as chloasma. Melasma is more common in sun-exposed tissues such as the cheeks, chin, upper lip, and forehead. Melasma is a common dermatological disorder with a frequency of 8.8 percent in the United States, but it can be as high as 40 percent amongst females. Melasma affects mostly ladies and is most common throughout their reproductive years . Melasma causes an increase in melanin pigment synthesis owing to a surge in the number of melanosomes, which are membrane-bound cell organelles inside melanocytes where melanin biosynthesis occurs and is transported to keratinocytes. Except in rare situations, the number of melanocytes will not be enhanced. Melanocytes will grow in size, and dendrites will become more visible. Despite the fact that the specific causation is unknown, some elements are thought to have a role in the pathophysiological mechanisms of melasma). Among these, sun exposure (UV light) is the most powerful primary trigger for its growth, which explains melisma's propensity for certain areas of the body. Other major determinants include genetic predisposition, and female hormones - both endogenous (that is, during pregnancy) and exogenous (that is, during pregnancy) (contraceptives and hormone replacement therapy). Thyroid problems, medications, and cosmetics can all be aggravating factors. Evaluation and prevention of triggering variables are essential in order to avoid recurrence . The peeling effect of glycolic acid is due to chemo exfoliation capabilities, that rely upon aiding the elimination of keratinocytes, resulting in melanin reduction and speeding up the regeneration of skin. TA suppresses UV-stimulated plasmin action in keratin cells by blocking plasminogen appending to the keratin cells, resulting from lower free arachidonic acid levels or to reduced capacity of prostaglandins production, which reduces melanocyte tyrosinase activity . The study's implications are to analyze the efficacy of these two drugs in order to assess the better outcome of patients with evidence-based management.

NCT ID: NCT05236569 Completed - Melasma Clinical Trials

Effectiveness and Safety of Intradermal Tranexamic Acid Injection as An Adjunctive Treatment for Melasma in Skin Type IV - V

Start date: February 1, 2021
Phase: N/A
Study type: Interventional

A double-blind, randomized, split-face controlled trial of 34 female patients with melasma was conducted. All subject were randomized to receive either intradermal tranexamic acid or placebo injection on the right or the left side of their face.

NCT ID: NCT05119413 Completed - Melanosis Clinical Trials

Comparison of a New Masterful Preparation to Kligman's Trio in the Treatment of Melasma

Kligman
Start date: November 30, 2021
Phase: Phase 2
Study type: Interventional

Kligman's trio remains the gold standard treatment for melasma. It contain hydroquinone which is an effective anti-melanogenic compound but that has poor tolerance and numerous side-effects. Thiamidol has been proven to be at least as effective as hydroquinone and has a very good safety profile. The objective of this study is to compare the Kligman's trio to the same preparation in which hydroquinone is replaced by thiamidol.