[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"epidermal-melasma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:epidermal-melasma":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,50],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100652809","phase-2-topical-metformin-versus-triple-regimen-for-epidermal-melasma-100652809",false,"NCT07779811","Topical Metformin Versus Triple Regimen for Epidermal Melasma","Comparison of Efficacy of Topical Triple Regimen Versus 30% Metformin in the Treatment of Epidermal Melasma","MET-MEL","Inclusion Criteria:\n\n* Male or female participants aged 18 to 50 years.\n* Confirmed diagnosis of epidermal melasma according to the study's operational definition.\n* Epidermal melasma confirmed by Wood's lamp examination, showing accentuated hyperpigmentation with enhanced contrast and sharp borders.\n* No treatment for epidermal melasma during the previous one month.\n* No dermabrasion, laser ablation, or chemical peel during the previous three months.\n* Willing to provide written informed consent.\n\nExclusion Criteria:\n\n* Acne vulgaris.\n* Rosacea.\n* Pregnancy.\n* Presence of comorbid conditions.","ALL","18 Years","50 Years",{"count":21,"type":22},104,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","Melasma is a common skin condition that causes dark brown patches, mainly on sun-exposed areas of the face. It is often persistent, may recur after treatment, and can affect a person's quality of life. The standard topical triple regimen used for melasma contains hydroquinone, tretinoin, and fluocinolone acetonide. Although effective, prolonged use may cause adverse effects such as redness, burning, peeling, telangiectasia, and steroid-related skin changes. Topical metformin has recently been investigated as a possible alternative treatment because it may reduce skin pigmentation with relatively few side effects.\n\nThis randomized clinical trial will compare the efficacy of topical 30% metformin cream with a topical triple regimen in adults with epidermal melasma. A total of 104 participants aged 18-50 years will be enrolled, with 52 participants assigned to each treatment group. Group A will receive topical 30% metformin, while Group B will receive a triple regimen containing 2% hydroquinone, 0.05% tretinoin, and 0.01% fluocinolone acetonide. Participants will apply the assigned treatment once daily at night for eight consecutive weeks. All participants will also be advised to use SPF 50 or higher sunscreen in the morning.\n\nTreatment efficacy will be assessed by comparing the modified Melasma Area and Severity Index score at baseline and after eight weeks. Treatment will be considered effective when the participant achieves at least a 25% reduction in the modified MASI score from baseline. The findings may help identify a more effective and acceptable topical treatment option for patients with epidermal melasma",[28,29],"Epidermal Melasma","Facial Hyperpigmentation",[31,28,29,32,33,34,35,36],"Melasma","Topical Metformin","Triple Combination Therapy","Modified MASI","Randomized Clinical Trial","Topical Treatment","NOT_YET_RECRUITING","2026-08-18",{"date":40,"type":41},"2026-08-21","ACTUAL",{"date":43,"type":22},"2026-08-15",{"date":45,"type":22},"2027-01-30",{"name":47,"class":48},"Combined Military Hospital, Pakistan","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":23,"phases":60,"briefSummary":62,"conditions":63,"keywords":66,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":49},"100598428","comparison-of-a-cosmetic-serum-and-4-hydroquinone-for-treating-melasma-over-84-days-100598428","NCT07071363","COMPARISON OF A COSMETIC SERUM AND 4% HYDROQUINONE FOR TREATING MELASMA OVER 84 DAYS","COMPARATIVE EVALUATION OF THE DERMATOLOGICAL TOLERANCE AND EFFICACY OF A COSMETIC SERUM VERSUS A 4% HYDROQUINONE-BASED PRODUCT IN SUBJECTS WITH MELASMA, AFTER 84 DAYS OF USE - STUDY CONDUCTED UNDER DERMATOLOGICAL SUPERVISION","Inclusion Criteria:\n\nMale or female subjects, primarily female, aged 18 to 65 years at the time of inclusion\n\nFitzpatrick skin phototype II to V\n\nDiagnosed with mild to moderate epidermal or mixed-type facial melasma, confirmed by Wood's lamp examination\n\nmMASI score between 3.5 and 13 at baseline\n\nSubject is in general good health as assessed by the investigator based on medical history and clinical examination\n\nWilling to avoid excessive sun exposure and use only the provided SPF50+ sunscreen during the study\n\nAble to understand the study procedures and provide written informed consent\n\nWilling and able to comply with study procedures and scheduled visits\n\nWomen of childbearing potential must agree to use a reliable method of contraception for at least 3 months prior to and during the entire study duration\n\nExclusion Criteria:\n\nPresence of post-inflammatory hyperpigmentation (PIH), lentigines, or other non-melasma facial pigmentation\n\nUse of topical or systemic depigmenting treatments, retinoids, corticosteroids, or hormonal treatments within 4 weeks prior to baseline\n\nKnown allergy or hypersensitivity to any component of the investigational or comparator products\n\nExcessive sun exposure or use of tanning beds within 2 weeks before baseline or planned during the study\n\nActive skin diseases (e.g., atopic dermatitis, psoriasis) or damaged skin in the test area\n\nPregnant or breastfeeding women, or those planning to become pregnant during the study\n\nParticipation in another clinical trial within 4 weeks prior to the study or planned participation in another trial during the study\n\nHistory of malignancy in the past 10 years (except treated basal cell carcinoma)\n\nUncontrolled systemic illness (e.g., diabetes, cardiovascular, hepatic, renal, or pulmonary disease)\n\nAny psychological or cognitive condition that would limit the subject's ability to understand the study procedures\n\nCurrent use of photosensitizing medications\n\nBMI \\> 40 or other conditions that may affect protocol compliance as judged by the investigator","65 Years",{"count":59,"type":22},40,[61],"NA","The goal of this clinical trial is to compare the dermatological tolerance and skin-lightening efficacy of a cosmetic depigmenting serum to a 4% hydroquinone-based product in adult male and female subjects aged 18-65 years with mild to moderate epidermal or mixed-type melasma.\n\nThe main questions it aims to answer are:\n\nDoes the cosmetic serum reduce the severity of melasma (measured by mMASI) after 84 days of use?\n\nIs the cosmetic serum better tolerated than 4% hydroquinone under real-use conditions?\n\nResearchers will compare the serum group and the hydroquinone group to determine whether the cosmetic product achieves comparable pigmentation improvement with superior skin tolerability.\n\nParticipants will:\n\nGroup 1: Apply a morning routine (Depiwhite Serum + Depiwhite M SPF50+ cream) Apply an evening routine (Depiwhite Serum + Placebo Cream without Hydroquinone)\n\nGroup 2: Apply a morning routine (Serum Placebo + Depiwhite M SPF50+ cream) Apply an evening routine (Serum Placebo + Depigmenting Cream with hydroquinone 4%)\n\nVisit the clinical site at baseline (Day 0), Day 56, and Day 84 for assessments\n\nComplete standardized photographs, self-assessment questionnaires, and quality-of-life surveys (MELASQoL and ASLQI)\n\nUndergo clinical evaluations by a dermatologist, including mMASI scoring and tolerance assessment",[64,65,28],"Healthy","Melasma (Facial Melasma)",[31,67,68],"Hyperpigmentation Skin","Pigmentation Disorders","RECRUITING","2025-08-15",{"date":72,"type":41},"2025-08-20",{"date":74,"type":41},"2025-06-23",{"date":76,"type":22},"2025-12-22",{"name":78,"class":79},"Laboratoire Dermatologique ACM","INDUSTRY"]