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

NCT00756288 | Withdrawn

• 1 other identifier: STU2574
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Actinic Keratoses

Keywords

Actinic Keratoses; Blue light therapy; photosensitizer; Retinoid

Outcome Measures

Primary Outcomes (1)

• 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).

  6 weeks

Secondary Outcomes (1)

• Subjects will assess pain, burning and itching on a scale of 0-3 at week 0, during retinoid treatment, during photo-therapy, one day after, and week 6. Also, principal investigator will evaluate adverse events at week 6.

  6 weeks

Study Arms (2)

1

EXPERIMENTAL

Topical retinoid and Light therapy with photosensitizing agent

Procedure: Topical retinoid and blue-light therapy with photosensitizing agent

2

ACTIVE COMPARATOR

Light therapy with photosensitizing agent

Procedure: Photodynamic Therapy (PDT)

Interventions

Topical retinoid and blue-light therapy with photosensitizing agent PROCEDURE

Topical Retinoid - Apply to AKs for 4 weeks Photo-therapy with photosensitizing agent- Apply to AKs at week 4

1

Photodynamic Therapy (PDT) PROCEDURE

Photo-therapy with sensitizing agent - apply to AKs at week 4

2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

Retinoids; Phototherapy; Photosensitizing Agents; Photochemotherapy

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors; Therapeutics; Dermatologic Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Radiation-Sensitizing Agents; Combined Modality Therapy; Drug Therapy

Study Officials

• Murad Alam, MD

  Northwestern University Department of Dermatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Dermatology

Study Record Dates

• First Submitted: September 19, 2008
• First Posted: September 22, 2008
• Study Start: March 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2017
• Last Updated: December 6, 2021

Record last verified: 2021-12