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A randomized, double-blind, multi-center, placebo-controlled phase III clinical trial to evaluate the effectiveness and safety of Yuhudie Quban Gao in treating chloasma caused by qi and blood stasis and lack of essence and blood.

A randomized, double-blind, multi-center, placebo-controlled phase III clinical trial to evaluate the effectiveness and safety of Yuhudie Quban Gao in treating chloasma caused by qi and blood stasis and lack of essence and blood.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400081321
Enrollment
Unknown
Registered
2024-02-28
Start date
2024-03-01
Completion date
Unknown
Last updated
2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chloasma caused by qi and blood stasis and insufficient essence and blood

Interventions

Control group:During the 12th week of the treatment period, apply the Yuhudie Quban Gao Simulation, an appropriate amount (2 fingertip units) at a time, 4 times a day, once a day in the morning, noon,
Treatment group:During the 12th week of the treatment period, apply an appropriate amount (2 fingertip units) of Yuhudie Quban Gao, 4 times a day, once a day in the morning, noon, evening and before g

Sponsors

Beijing Hospital of Traditional Chinese Medicine, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

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

MeasureTime 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

MeasureTime 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

Public ContactDongmei Zhou

Beijing Hospital of Traditional Chinese Medicine, Capital Medical University

52176857@163.com+86 138 1120 1580

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026