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A Randomized Controlled Study of GM-CSF to lmprove PIH After Laser Treatment of Solar Lentigines

A Randomized Controlled Study of GM-CSF to lmprove PIH After Laser Treatment of Solar Lentigines

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500108018
Enrollment
Unknown
Registered
2025-08-22
Start date
2025-09-01
Completion date
Unknown
Last updated
2025-08-25

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

Conditions

Solar Lentigines

Interventions

Group A:Laser+gel Left face control group (general medical gel), right face test group (GM-CSF gel)
Group B:Laser+gel Right face control group (general medical gel), left face test group (GM-CSF gel)

Sponsors

Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Patients aged 40–70 years (inclusive), regardless of gender; 2.Presence of characteristic sunspots on the face, each measuring >2mm × 2mm; 3.Concurrent facial pigmentation disorders such as melasma or freckles in addition to sunspots; 4.Fitzpatrick Skin Phototype (SPT) III to V; 5.No contraindications to GM-CSF therapy; 6.Non-occupational outdoor workers; 7.Demonstrated good compliance and ability to complete follow-up visits; 8.Voluntary participation in the study with signed informed consent.

Exclusion criteria

Exclusion criteria: 1.Pregnant or breastfeeding women; 2.Patients with other refractory pigmentary disorders on the face (e.g., vitiligo, Riehl's melanosis, etc.); 3.Presence of severe acne, eczema, allergic dermatitis, or other conditions in the treatment area, or factors significantly affecting efficacy evaluation (e.g., prominent scars, excessive hair growth, etc.); 4.Concurrent participation in other facial cosmetic clinical trials during the study period; 5.Unwillingness to discontinue all whitening and spot-lightening cosmetics during the study or inability to maintain proper sun protection measures; 6.Systemic diseases (including but not limited to liver or cardiovascular diseases, dyslipidemia, anemia, coagulation disorders, infectious diseases, psoriasis, diabetes, etc.); 7.History of excessive sun exposure within 1 month prior to study initiation; 8.Any treatment for sunspots (including chemical peels, laser therapy, intense pulsed light, medications, etc.) within the past 6 months.

Design outcomes

Primary

MeasureTime frame
Incidence of PIH;

Secondary

MeasureTime frame
Change rate of brown spot grayscale;Patient satisfaction evaluation;Change rate of UV spot grayscale;Change rate of sunspot area;

Countries

China

Contacts

Public ContactYao Min

Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine

my058@vip.sina.com+86 18917797606

Outcome results

None listed

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