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Efficacy and safety of a New compound whitening cream containing Yunnan Camellia in the treatment of melasma: A randomized, double-blind, placebo-controlled clinical trial

Efficacy and safety of a New compound whitening cream containing Yunnan Camellia in the treatment of melasma: A randomized, double-blind, placebo-controlled clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-INR-17012531
Enrollment
Unknown
Registered
2017-09-01
Start date
2017-09-01
Completion date
Unknown
Last updated
2017-09-04

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

Conditions

Melasma/Chloasma

Interventions

Experiment group:A new whitening formula
Control group:Arbutin whitening formula
Placebo group:Placebo

Sponsors

The First Hospital Affiliated of Kunming Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
25 Years to 55 Years

Inclusion criteria

Inclusion criteria: 1. At the age of 25-55 years old, male or female, without a clear system of organic disease; 2. Meet the diagnostic criteria of melasma; 3. Patients are willing to use SPF>30 sunscreen during the entire study period without direct exposure to the sun; 4. Patients did not use any other freckle or whitening products or received other treatments (drugs, chemical stripping, laser, etc.) in the first 1 months; 5. During the whole study period, no other freckle removing, whitening products and other treatments (drugs, lasers, etc.) were used; 6. Patients have signed the informed consent and are willing to complete the study.

Exclusion criteria

Exclusion criteria: 1. Patients have serious heart, kidney, liver, endocrine system disease or the patient that has tumor and immune deficient disease; 2. Pregnant or lactating women; 3. Patients have used other freckle, whitening products, or accepted other treatment methods (such as: drugs, chemical stripping, laser, etc.)for 1 month before studyl; 4. Does not meet the diagnostic criteria of melasma; 5. Patients suffering from herpes simplex, sensitive skin, or have broken, impregnated, erosion and other skin lesions; 6. Known to be allergic to the subject; 7. Can not guarantee not to use other freckle, whitening products, and accept other treatment methods (such as: drugs, lasers, etc.) throughout the study period; 8. Staff directly involved in the study; 9. Patients currently participating in other clinical studies or have participated in other clinical studies within 3 months.

Design outcomes

Primary

MeasureTime frame
Melasma area severity index(MASI);Lab (CM-2600d, Minolta, Japan);VISIA(VISIA-CR, Canfield, USA).;Skin physiology function test(MX 18;Courage &Khazaka, Germany);Physicians Global Assessment (PGA);Subjects Assessment;Dermoscopy;Confocal scanning laser microscopy (CSLM);

Countries

China

Contacts

Public ContactLi He

The First Hospital Affiliated of Kunming Medical University

drheli2662@126.com+86 13608711764

Outcome results

None listed

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