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A Multicenter, Prospective, Observational Real-World Study on the Efficacy and Safety of Fluocinolone Acetonide, Hydroquinone and Tretinoin Cream in the Treatment of Moderate to Severe Melasm

A Multicenter, Prospective, Observational Real-World Study on the Efficacy and Safety of Fluocinolone Acetonide, Hydroquinone and Tretinoin Cream in the Treatment of Moderate to Severe Melasm

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600123134
Enrollment
Unknown
Registered
2026-04-22
Start date
2026-04-22
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

Melasma

Interventions

Observation group:None

Sponsors

The Affiliated Hospital of Chengde Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age: 18 years old <= age <= 75 years old, no gender restriction; 2. Meet the above Western medical diagnostic criteria for chloasma and/or facial wrinkles; 3. Plan to use silkworm cocoon powder externally in real diagnosis and treatment scenarios and can adhere to the use; 4. Have basic communication and cognitive abilities, and can cooperate in completing basic efficacy evaluation and safety records; 5. Voluntarily participate in this study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Individuals with allergy or intolerance to the active ingredients or excipients (contraindicated as clearly stated in the product instructions); 2. Pregnant or lactating women, or those planning a pregnancy in the near future (risk noted in the product instructions); 3. Individuals with concurrent active skin lesions, or a history of ochronosis or Cushing's syndrome; 4. Individuals who have used other depigmenting agents, systemic glucocorticoids, or photosensitizing drugs within the past 1 month; 5. Individuals unable to comply with sun protection measures.

Design outcomes

Primary

MeasureTime frame
MASI/mMASI;

Secondary

MeasureTime frame
Local skin adverse events;

Countries

China

Contacts

Public ContactJiang Song

The Affiliated Hospital of Chengde Medical University

896223731@qq.com+86 314 227 9312

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 1, 2026