Chloasma caused by qi and blood stasis and insufficient essence and blood
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Meet the Western medical diagnostic criteria for chloasma; (2) Meet the TCM syndrome differentiation standards for kidney deficiency and blood stasis syndrome or qi stagnation and blood stasis syndrome; (3) Aged 18-60 years old (both ends inclusive) at the time of informed consent, no gender limit; (4) Voluntarily participate in this trial and have signed the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Face combined with acne, eczema, atopic dermatitis, scars or other abnormal pigment diseases, such as post-inflammatory pigmentation, malar brown-green nevus, Riehl's melanosis, lichen planus pigmentosa, Addison's disease, Civatte skin abnormalities Pigmentation disease, nevus of Ohta, and other combined facial pigment diseases that affect the evaluation of efficacy according to the researcher's judgment; (2) Those who have taken oral or external Chinese and Western medicines for the treatment of chloasma in the past month, and those who have undergone acupuncture, thread embedding, scraping, etc.; those who have undergone laser or skin resurfacing treatments in the past 9 months; (3) Those who have had more than 2 spontaneous abortions; (4) Outdoor workers who are exposed to sunlight for a long time; (5) Those who are known to be allergic to the ingredients contained in the trial drugs and the cleansing, basic skin care, and sunscreen products provided; (6) Those with serious heart, liver, lung, kidney, blood, endocrine and other systemic diseases, or malignant tumors; (7) Women who are pregnant, lactating, or planning to become pregnant, and who themselves or their partners do not agree to use effective contraceptive measures other than oral contraceptives during the trial; (8) Those who have severe neurological or mental illness and are unable to fully understand and cooperate; (9) Smokers or those with a history of alcohol or drug abuse; (10) Those who have participated or are currently participating in other clinical trials within 3 months before enrollment; (11) Other circumstances in which the researcher deems it inappropriate to participate in clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Melasma Area and Severity Index (MASI) score reduction rate. MASI score reduction rate = (MASI score before treatment - MASI score after treatment) / MASI score before treatment × 100%; | — |
Secondary
| Measure | Time frame |
|---|---|
| Melasma Area and Severity Index (MASI) score reduction rate;The efficacy of TCM syndromes;Physician's Global Assessment (PGA) score;Melasma Quality of Life scale(MELASQOL) score change rate; | — |
Countries
China
Contacts
Beijing Hospital of Traditional Chinese Medicine, Capital Medical University