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Photo-therapy With a Topical Retinoid Versus Photo-therapy Alone for Actinic Keratoses

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Northwestern University

Status

Withdrawn

Conditions

Actinic Keratoses

Treatments

Procedure: Photodynamic Therapy (PDT)
Procedure: Topical retinoid and blue-light therapy with photosensitizing agent

Study type

Interventional

Funder types

Other

Identifiers

NCT00756288
STU2574

Details and patient eligibility

About

Evaluating safety and efficacy of the use of topical retinoid with photodynamic therapy for the treatment of actinic keratoses.

Full description

Evaluating safety and efficacy of the use of topical retinoid with photodynamic therapy vs photodynamic therapy alone for the treatment of actinic keratoses.

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

  • Adults aged 18-80 years old
  • Subjects with AK lesions who will receive PDT
  • Subjects with AK lesions in two areas other than face and scalp each with a surface area of 10cm2 or greater and at least 3 clinically diagnosed non-hypertrophic AK lesions in each
  • Subjects in good health
  • Subjects with willingness and the ability to understand and provide informed consent

Exclusion Criteria

  • Subjects who are pregnant or lactating
  • Subjects with a history of cutaneous photosensitivity or porphyria, hypersensitivity to porphyrins, or photodermatosis
  • Subjects with use of photosensitizing drugs within 1 week of study start
  • Subjects with use of topical medications such as corticosteroids, alpha-hydroxyacids or retinoids 2 weeks before study entry
  • Subjects who received previous treatment of target AKs within 4 weeks
  • Subjects who are unable to understand the protocol or give informed consent

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

0 participants in 2 patient groups

1
Experimental group
Description:
Topical retinoid and Light therapy with photosensitizing agent
Treatment:
Procedure: Topical retinoid and blue-light therapy with photosensitizing agent
2
Active Comparator group
Description:
Light therapy with photosensitizing agent
Treatment:
Procedure: Photodynamic Therapy (PDT)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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