Melasma
Conditions
Interventions
Experimental Group:Apply a thin film of Fluocinolone acetonide, Hydroquinone and Tretinoin Cream to the affected area once daily, at least 30 minutes before bedtime, for 8weeks. During the day, use a
Control Group:Apply a thin film of TRI-LUMA Cream to the affected area once daily, at least 30 minutes before bedtime, for 8 weeks. During the day, use a moisturizer and a sunscreen and use protecti
Placebo Group:Apply a thin film of Placebo (Vehicle) Cream to the affected area once daily, at least 30 minutes before bedtime, for 8 weeks. During the day, use a moisturizer and a sunscreen and use p
Sponsors
The First Affiliated Hospital of China Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: (1) Patients of either gender aged between 18 and 60 years; (2) The patients have the moderate to severe melasma (melasma severity scores of =2 on a 0 to 3 scale, with 2 indicating moderate severity) at baseline visit; (3) The patients are with stable hyperpigmentation of the face for at least 3 months and macular lesions that are neither depressed nor atrophic; (4) Females of childbearing potential agree to utilize an adequate form of contraception 2 weeks prior to the study, and have no pregnancy plan and take effective birth control measures throughout the study and also within 3 months after the endpoint of drug administration. (5) Willingness to use the products provided in study treatment, including the facial cleanser, the moisturizer, and the sunscreen; (6) Fully understand the content, procedure and the potential adverse events of the clinical trial and willing to sign the informed consent form and able to complete the study in accordance with the requirement of the protocol.
Exclusion criteria
Exclusion criteria: (1) Females who are pregnant, breast feeding, or planning a pregnancy; (2) Any facial skin condition that would interfere with the diagnosis of melasma and/or with determination of melasma severity (including but not limited to facial acne, eczema, allergic dermatitis, scar or other dyschromic diseases, such as nevus fuscocaeruleus zygomaticus, vitiligo, Riehls melanosis); (3) Immunocompromised or under immunosuppressive treatment; (4) Allergic to sulfites; (5) Known hypersensitivity reactions to systemic or topical corticosteroids, topical hydroquinone, topical or oral tretinoin, or any of the test product or RLD excipients; (6) Known to be allergic to the provided facial cleanser, moisturizer, and sunscreen in this clinical trial; (7) Patients who undergo the laser, dermabrasion or peels within 6 months prior to the baseline visit; (8) Use within four weeks prior to the baseline visit of any topical or oral drugs (such as hydroquinone, corticosteroids, and retinoids) in the treatment of melasma, or any drugs that may interfere with the pigment synthesis or metabolism (such as tryptophan, cysteine, aminomethylcyclic acid, reduced glutathione, and etc.), bleaching products, ultraviolet (UV) light therapy sunbathing, acupuncture, catgut embedding, scraping and other treatments; (9) Use within 3 months prior to the baseline visit of any acitretin, azathioprine, cyclosporine, interferon, isotretinoin, methotrexate, mycophenolate mofetil, sirolimus, tacrolimus, or any photoallergic, phototoxic, or photosensitizing drugs; (10) Use within 2 weeks prior to the baseline visit of drugs categories including anti-inflammatory, antihistamine, hypnotics; (11) Patients who had been enrolled in the other medical or drug clinical trials within 3 months prior to the drug administration; (12) The abnormal test results obtained from vital signs, physical examination, and laboratory examinations (blood routine parameters, urine routine parameters, liver and kidney function and 12 ECG) that are found to be clinically significant, or other clinical findings showed the diseases of clinically significance (including but not limited to the skin, respiratory system, circulatory system, digestive system, endocrine system, urinary system, blood system, nervous system or mental disorders, and etc.) ; (13) Patients who have exposure to the sun on a regular/long-term basis; (14) Other unsuitable conditions confirmed by the investigator for the enrollment for the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Melasma Severity Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Melasma Area and Severity Index (MASI);Melasma Quality of Life Scale; | — |
Countries
China
Contacts
Public ContactXinghua Gao
The First Affiliated Hospital of China Medical University
Outcome results
None listed