[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602279":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":56,"collaborators":26,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":26,"eligibilityCriteria":66,"healthyVolunteers":67,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":26,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":26,"overallStatus":81,"whyStopped":26,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Indonesia University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"treatment","EXPERIMENTAL","Participants receive the test serum containing Melasyl™, Niacinamide 10%, Hyaluronic Acid, and HEPES every morning and night, plus SPF \\>30 sunscreen every morning.",[13],"Drug: a combination serum containing Melasyl™, 10% Niacinamide, Hyaluronic Acid, and HEPES",{"label":15,"type":16,"description":17,"interventionNames":18},"control","ACTIVE_COMPARATOR","Participants receive 2% hydroquinone cream at night and SPF \\>30 sunscreen every morning.",[19],"Drug: 2% hydroquinone cream",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","a combination serum containing Melasyl™, 10% Niacinamide, Hyaluronic Acid, and HEPES","Subjects were randomized to receive a combination serum The combination serum contained Melasyl™, 10% Niacinamide, Hyaluronic Acid, and HEPES. applied twice daily, following QS-Nd:YAG 1064 nm low-fluence laser treatment. Clinical evaluations were conducted at baseline and at Weeks 1, 2, and 4 post-laser to assess pigmentation improvement, erythema, and overall skin condition.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"2% hydroquinone cream","Subjects were randomized to received 2% hydroquinone cream, applied once daily at night, following QS-Nd:YAG 1064 nm low-fluence laser treatment. Clinical evaluations were conducted at baseline and at Weeks 1, 2, and 4 post-laser to assess pigmentation improvement, erythema, and overall skin condition.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Prof. Irma Bernadette S Sitohang, MD., PhD.","CONTACT","+62818130761","irma_bernadette@yahoo.com",[38],{"facility":39,"status":26,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Gatot Soebroto Central Army Hospital","Jakarta Pusat","Jakarta Special Capital Region","10410","Indonesia","ID",{"type":46,"coordinates":47},"Point",[48,49],106.8223,-6.1818,{"lat":49,"lon":48},[52,53],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},{"name":54,"role":55,"phone":26,"phoneExt":26,"email":26},"Prof. Irma Bernadette S Sitohang, MD., PhD","PRINCIPAL_INVESTIGATOR",{"type":57,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Dr.dr.Irma Bernadette, SpKK (K)","Prof. Dr. dr. Irma Bernadette S. Sitohang, Sp.D.V.E., Subsp.D.K.E. - Head of Cosmetic Dermatology Division, Department of Dermatology and Venereology, Faculty of Medicine, Universitas Indonesia, dr. Cipto Mangunkusumo Hospital, Jakarta, Indonesia","100602279","efficacy-and-safety-of-a-combined-serum-containing-melasyl-10-niacinamide-hyaluronic-acid-and-hepes-100602279",false,"NCT07121439","Efficacy and Safety of a Combined Serum Containing Melasyl™, 10% Niacinamide, Hyaluronic Acid, and HEPES","The Efficacy and Safety of a Combined Serum Containing Melasyl™, 10% Niacinamide, Hyaluronic Acid, and Hydroxyethylpiperazine Ethane Sulfonic Acid Following Low-Fluence Q-Switched Nd:YAG 1064 nm Laser Treatment for Melasma and Post-Acne Hyperpigmentation Therapy","Inclusion Criteria:\n\n* Female, aged 18-60 years.\n* Patients diagnosed with post-acne hyperpigmentation and melasma based on clinical examination and Wood's lamp evaluation, with Fitzpatrick skin types IV and V.\n* Patients visiting the Dermatology and Venereology Outpatient Clinic and scheduled to undergo QS Nd:YAG 1064 nm low-fluence laser treatment.\n\nPatients who are currently receiving or have received a priming regimen for at least two weeks prior to the laser procedure, consisting of either 2% hydroquinone cream or a serum containing Niacinamide 10%, Hyaluronic Acid, and HEPES.\n\n\\- Willing to participate in the study and provide written informed consent after receiving a complete explanation of the study procedures.\n\nExclusion Criteria:\n\n* Pregnant, breastfeeding, or currently taking oral contraceptives at the time of evaluation.\n* History of systemic retinoid use within the past three months.\n* History of or ongoing treatment for hormonal\u002Fendocrine disorders or other severe systemic illnesses.\n* Currently undergoing immunosuppressive therapy.\n* Difficulty adhering to treatment protocols.",true,"FEMALE","18 Years","60 Years",{"count":72,"type":73},68,"ESTIMATED","INTERVENTIONAL",[76],"NA","The goal of this clinical trial is to evaluate the efficacy and safety of a combination serum containing Melasyl™, 10% Niacinamide, Hyaluronic Acid, and HEPES when used as a moisturizer after QS-Nd:YAG 1064 nm low-fluence laser treatment for melasma and post-acne hyperpigmentation.\n\nThe study aims to answer the following main questions:\n\n* Does the combination serum reduce hyperpigmented lesions after laser treatment for melasma and post-acne hyperpigmentation?\n* Does the serum improve skin hydration following laser therapy for melasma?\n* Is the combination serum safe for use after laser treatment, without causing irritation or adverse effects?\n\nParticipants will be female patients aged 18-60 years, clinically diagnosed with melasma or post-acne hyperpigmentation (skin types IV and V), who visit the Dermatology \\& Venereology Outpatient Clinic for QS-Nd:YAG 1064 low-fluence laser treatment. All participants will have undergone a 2-week priming period using either 2% hydroquinone cream or the test serum prior to laser treatment. Written informed consent is required.\n\nParticipants will be randomly assigned to receive either the test serum or 2% hydroquinone cream based on a coded allocation. The product will be applied twice daily after facial cleansing, and sunscreen will be used 15 minutes before outdoor activities. Treatment lasts for 2 weeks, with participants recording application times and any adverse effects in a diary. Evaluations-including facial photography, mMASI, mexameter, dermoscopy, Wood's lamp, and PAHPI-will be conducted at baseline and at 1, 2, and 4 weeks post-laser. Erythema and subjective assessment (VAS) will be performed 15 minutes after the laser procedure.",[79,80],"Melasma","Post-acne Hyperpigmentation","NOT_YET_RECRUITING","2025-08-06",{"date":84,"type":85},"2025-08-13","ACTUAL",{"date":87,"type":73},"2025-09-15",{"date":89,"type":73},"2025-12-01",{"name":58,"class":6},1]