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A Randomized Controlled Paired Comparison of Photo-therapy With a Topical Retinoid Cream Pretreatment Versus PDT Alone for Actinic Keratoses


N/A
18 Years
80 Years
Not Enrolling
Both
Actinic Keratoses

Thank you

Trial Information

A Randomized Controlled Paired Comparison of Photo-therapy With a Topical Retinoid Cream Pretreatment Versus PDT Alone for Actinic Keratoses


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

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Live blinded rater and blinded photo rater analysis of areas at week 0 and week 6 for erythema, edema, crusting, ulceration, palpability, need to cease/delay treatment, and overall response in reduction of number of actinic keratoses (AKs).

Outcome Time Frame:

6 weeks

Safety Issue:

No

Principal Investigator

Murad Alam, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Northwestern University Department of Dermatology

Authority:

United States: Institutional Review Board

Study ID:

STU2574

NCT ID:

NCT00756288

Start Date:

June 2013

Completion Date:

March 2014

Related Keywords:

  • Actinic Keratoses
  • Actinic Keratoses
  • Blue light therapy
  • photosensitizer
  • Retinoid
  • Keratosis
  • Keratosis, Actinic
  • Ichthyosis
  • Keratoacanthoma

Name

Location
Northwestern University Department of Dermatology Chicago, Illinois  60611