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Melasma clinical trials

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NCT ID: NCT06454747 Recruiting - Melasma Clinical Trials

A Randomized, Observer-Blinded, Placebo-Controlled Study on Safety and Efficacy of SM-030 in Adults With Melasma

Start date: June 6, 2024
Phase: Phase 2
Study type: Interventional

This is a phase 2b, observer-blinded, randomized study that will evaluate the safety and efficacy of topically applied SM-030 gel 0.64% and SM-030 gel 0.08% compared against placebo gel in healthy adult male and female subjects with Melasma. The study will be comprised of a 12-week twice daily dosing period and a 4-week additional safety follow-up period. Approximately 138 subjects who meet the eligibility criteria, notably with a clinical diagnosis of Melasma will be randomized in a 3:2:1 ratio to one of three treatment arms: SM-030 gel 0.64% (N=69), Placebo gel (N=46), or SM-030 gel 0.08% (N=23). Subjects will be competitively enrolled in Mexico and El Salvador across 5 sites (4 sites in Mexico and 1 in El Salvador). Subjects will be assessed for safety and efficacy at each visit.

NCT ID: NCT06415435 Recruiting - Melasma Clinical Trials

Sylfirm X Radiofrequency Microneedling for the Treatment of Melasma

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

Microneedling radiofrequency technology has been shown in clinical studies to improve skin quality, tone, pigment, and to treat various skin conditions related to aging. The purpose of this study is to evaluate efficacy and safety of Sylfrim X device for the treatment of melasma.

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: NCT06278948 Recruiting - Melasma Clinical Trials

Efficacy and Tolerability of Test Product Versus Cysteamine 5% in Treatment of Facial Epidermal Melasma

Start date: October 6, 2023
Phase: N/A
Study type: Interventional

This interventional, randomized, investigator blinded, controlled study conducted in one centre consists in a 4-month evaluation period within the same season avoiding sunny season on 140 subjects with facial epidermal melasma.

NCT ID: NCT06221787 Recruiting - Melasma Clinical Trials

Stem Cell Derived Exosomes in the Treatment of Melasma and Its Percutaneous Penetration

Start date: April 1, 2022
Phase: N/A
Study type: Interventional

Melasma is a refractory skin disease due to its complex pathogenesis and difficult treatment. Studies have found that human umbilical cord mesenchymal stem cell-derived exosomes (hUCMSC-Exos) could serve as a novel cell-free therapeutic strategy in regenerative and aesthetic medicine. It could potentially treat melasma, but the skin barrier is a challenge. This study aims to explore the safety and efficacy of hUCMSC-Exos in the treatment of melasma and means to promote its percutaneous penetration.

NCT ID: NCT06201624 Recruiting - Melasma Clinical Trials

Oral Isotretinoin in Melasma a Randomized Controlled Trial

Start date: March 1, 2023
Phase: Phase 1
Study type: Interventional

Melasma is a common refractory acquired hyperpigmentation of the skin having a serious impact on patients' quality of life. Melasma is challenging to treat. Treatment is often a multimodality approach. Due to the attached psychological and social stress, it is important to counsel patients with melasma adequately about the chronicity of the disease, the importance of photoprotection, and the role of hormones in disease persistence before embarking on therapeutic correction. So in this study, we are exploring the efficacy of oral isotretinoin for treating melasma.

NCT ID: NCT06174545 Recruiting - Melasma Clinical Trials

Effectiveness and Safety of Pigment Solution Program (PSP) as Adjuvant Therapy in Melasma

Start date: September 25, 2023
Phase: N/A
Study type: Interventional

This research is a clinical study with a single-blind randomized clinical trial design (randomized controlled trial) in multicenters at two Dermatology and Venereology Education centers in Indonesia. This study aims to determine the effectiveness and safety of PSP as adjuvant therapy for melasma. This research will be attended by 33 research subjects

NCT ID: NCT06153134 Recruiting - Melasma Clinical Trials

Curcuma Xanthorriza Roxb. 10% Cream for Melasma

Start date: December 22, 2023
Phase: Early Phase 1
Study type: Interventional

Melasma is an acquired hyperpigmentation disorder with a multifactorial etiology and complex pathogenesis that can significantly diminish the quality of life for affected patients. As of now, melasma therapy remains challenging due to its high recurrence rate and the common occurrence of treatment-related side effects. The use of depigmentation agents is a crucial component in managing melasma. Hydroquinone stands as the first-line depigmentation agent for melasma; however, its use often leads to adverse effects. Therefore, alternative depigmentation agents are needed. Curcuma xanthorriza Roxb., a native plant of Indonesia, operates by inhibiting the tyrosinase enzyme, reducing MITF transcription, and inhibiting α-MSH. Despite these potential benefits, Curcuma xanthorriza Roxb. has not been utilized as a depigmentation agent. Research on the effectiveness of Curcuma xanthorriza Roxb. as a depigmentation agent in melasma treatment has not been conducted. Therefore, it is essential to conduct research to determine the effectiveness of a 10% Curcuma xanthorrhiza Roxb. cream in reducing MASI scores and enhancing skin brightness in epidermal-type melasma.

NCT ID: NCT06013540 Active, not recruiting - Melasma Clinical Trials

Comparison Of Efficacy Of Combination Of TAM Formula Vs Kligman Formula For Melasma.

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

This study would offer the participants about the knowledge of these formula in the treatment of melasma and help the investigators in incorporating and updating the management protocols in medical practice.

NCT ID: NCT06010810 Active, not recruiting - Melasma Clinical Trials

The Effectiveness of 3% Topical Tranexamic Acid Compared to 4% Topical Hydroquinone as Therapy of Melasma

Start date: June 1, 2023
Phase: Phase 3
Study type: Interventional

The goal of this clinical trial is to compare 3% Topical Tranexamic Acid with 4% Topical Hydroquinone as Therapy of Melasma in Patients with Skin Type III-V. The main question[s] it aims to answer are: 1. Is there a greater decrease in mMASI score after application of 3% topical tranexamic acid compared to 4% hydroquinone in melasma patients with skin type III - V? 2. Is there a greater decrease in mexameter score after application of 3% topical tranexamic acid compared to 4% hydroquinone in melasma patients with skin type III - V? 3. Are there any side effects of topical therapy of 3% tranexamic acid cream on melasma patients with skin types III - V? Participants with melasma diagnostic will apply the tranexamic acid cream and hydroquinone cream on both sides of the face differently. Researchers will compare by measuring the mexameter score and mMasi score to see if there any decrease in both sides of the face.