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

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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00756288

Enrollment

Registered

2008-09-22

Start date

2016-03-31

Completion date

2017-12-31

Last updated

2021-12-06

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

Conditions

Actinic Keratoses

Keywords

Actinic Keratoses, Blue light therapy, photosensitizer, Retinoid

Brief summary

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

Detailed description

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

Interventions

PROCEDURETopical retinoid and blue-light therapy with photosensitizing agent

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

PROCEDUREPhotodynamic Therapy (PDT)

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026