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Dermoscopy for monitoring therapeutic response to non-surgical treatments of in-situ squamous cell carcinoma.

Applicability of dermoscopy for evaluation of the effectiveness of Imiquimod cream, Photodynamic therapy and Cryotherapy in the treatment of actinic keratosis and Bowen's disease.

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12613000207718
Enrollment
100
Registered
2013-02-21
Start date
2013-02-25
Completion date
Unknown
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

Primary purpose is to identify whether certain dermoscopic criteria can predict the presence or absense of residual disease after non surgical treatment (miquimod cream , phodynamic treatment or cryotherapy) of in situ squamous cell carcinomas (actinic keratosis and Bowen's disease) with sufficient sensitivity and specificity

Interventions

Identify specific dermoscopic features of biopsy proven Actinic Keratosis and Bowen's Disease before and after treatment with Imiquimod cream or Photodynamic therapy or cryotherapy in order to specify the presence or not of residual disease. Actinic keratosis will be treated either with 1 freeze thaw cycle of cryotherapy with liquid nitrogen OR2 sessions of methylaminolevulinate PDT (MAL-PDT, Metvix PDT), one week apart,or imiquimod cream applied 3 days/week for 12 weeks.Bowen’s disease will be

Identify specific dermoscopic features of biopsy proven Actinic Keratosis and Bowen's Disease before and after treatment with Imiquimod cream or Photodynamic therapy or cryotherapy in order to specify the presence or not of residual disease. Actinic keratosis will be treated either with 1 freeze thaw cycle of cryotherapy with liquid nitrogen OR2 sessions of methylaminolevulinate PDT (MAL-PDT, Metvix PDT), one week apart,or imiquimod cream applied 3 days/week for 12 weeks.Bowen’s disease will be treated with 2 freeze-thaw cycles of cryotherapy or 2 sessions of MAL-PDT, one week apart or imiquimod 5% cream applied 5 days/week for 12 week. Dermoscopic evaluation will be performed at baseline, 4 and 12 weeks after last treatment intervention. Participants will be observed in total for their treatment period and for 12 weeks after their last treatment intervention.

Sponsors

Aristotle University of Thessaloniki
Lead SponsorUniversity

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

18 years of age Biopsy proven actinic keratosis or Bowen's disease

Exclusion criteria

pregnancy and lactation History of hypersensitivity in imiquimod or amilevulinate acid photosensitivity for Photodynamic therapy group

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026