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IRCT20161207031288N13 IRCT 2022-07-11 Tehran University of Medical Sciences Evaluation of NLC nanoparticles containing hydroquinone, tretinoin, and fluocinolone in the treatment of melasma Evaluation of safety and efficacy of Nanostructured lipid carrier( NLC) nanoparticles containing hydroquinone, tretinoin, and fluocinolone compared with conventional formulation in the treatment of melasma 2022-07-23 anticipated 20 Complete https://irct.ir/trial/58452 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Each patient with melasma is given two prepared creams in the form of identical packages coded as A and B. The evaluating physician and the patient are both unaware of the ingredients in the two creams. Cream A is said to be rubbed to the left and cream B to the right of the face or vice versa, Blinding description: Evaluating physician and the patient are both unaware of the ingredients in the two creams. 2 melasma. Intervention 1: Intervention group: use of Nanostructured lipid carrier( NLC) nanoparticles containing hydroquinone, tretinoin and fluosinolone made in lab, in patients with moderate to severe melasma in one side of patient's face once in a day for 8 weeks. Intervention 2: Control group: use of commercial formulations containing hydroquinone, tretinoin and fluosinolone made by Janus pharma company, in patients with moderate to severe melasma on one side of the patient's face once in a day for 8 weeks. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Saman Ahmad Nasrollahi
No. 415, Taleqni Ave., Tehran, Iran
Tehran Iran (Islamic Republic of) 1416613675 0098 21 8897 792 samannasrol@gmail.com Tehran University of Medical Sciences scientific Alireza firooz
No. 415, Taleqni Ave., Tehran, Iran
Tehran Iran (Islamic Republic of) 1416613675 098 21 8897 7921 firozali@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) 18 - 50 years old men and women Case of approximately symmetrical moderate to severe melasma (melasma global severity score(MGSC)>2) No topical and systemic treatment for melasma during the last 4 weeks Appropriate general health condition No change in life style during the study Signing the consent form of the candidate to participate in the study and the desire to attend regular follow-up courses 18 years 50 years Both Pregnant people or those who plan to become pregnant during the study People with known allergies to any of the components of the cream History of using each of the mentioned compounds topically in the last 21 days: Corticosteroids, retinoid compounds, chemical peels, alpha hydroxy acid and beta hydroxy acid compounds History of systemic use of each of the mentioned compounds in the last 28 days: corticosteroids, tretinoin compounds, interferon types Patients with rosacea, skin atrophy, acne and eczema History of use of drugs that increase photosensitivity in the last 3 months People who have had laser skin peeling or microdermabrasion in the last 3 months If the doctor of the study determines that the volunteer is not appropriate for this study by some reaons L81.1 Chloasma Treatment - Drugs Treatment - Drugs Intervention group: use of Nanostructured lipid carrier( NLC) nanoparticles containing hydroquinone, tretinoin and fluosinolone made in lab, in patients with moderate to severe melasma in one side of patient's face once in a day for 8 weeks Control group: use of commercial formulations containing hydroquinone, tretinoin and fluosinolone made by Janus pharma company, in patients with moderate to severe melasma on one side of the patient's face once in a day for 8 weeks Modified melasma severity index. Timepoint: Before intervention, 4 weeks later, 8 weeks after intervention. Method of measurement: Using mMASI(modified Melasma Severity Index). Skin pH. Timepoint: Before intervention, 4 weeks later, 8 weeks after intervention. Method of measurement: MPA 580. Skin sebum. Timepoint: Before intervention, 4 weeks later, 8 weeks after intervention. Method of measurement: MPA 580. Skin melanin and erythem. Timepoint: Before intervention, 4 weeks later, 8 weeks after intervention. Method of measurement: MPA 580. Trance Epidermal Water Lost (TEWL). Timepoint: Before intervention, 4 weeks later, 8 weeks after intervention. Method of measurement: MPA 580. Size and value of skin spot. Timepoint: Before intervention, 4 weeks later, 8 weeks after intervention. Method of measurement: Visio face. Tehran University of Medical Sciences Approved 2021-03-07 Ethics committee of Tehran University of Medical Sciences Research and Technology Dept, 6th floor, Central Organization of the University, Ghods St., Keshavarz Blvd. Tehran Tehran Iran (Islamic Republic of)