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Evaluating safety and efficacy of the use of topical retinoid with photodynamic therapy for the treatment of 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Topical retinoid and Light therapy with photosensitizing agent |
|
| 2 | Active Comparator | Light therapy with photosensitizing agent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Murad Alam, MD | Northwestern University Department of Dermatology | Principal Investigator |
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| ID | Term |
|---|---|
| D055623 | Keratosis, Actinic |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D007642 | Keratosis |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D012176 | Retinoids |
| D010789 | Phototherapy |
| D017319 | Photosensitizing Agents |
| D010778 | Photochemotherapy |
| ID | Term |
|---|---|
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
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| Photodynamic Therapy (PDT) | Procedure | Photo-therapy with sensitizing agent - apply to AKs at week 4 |
|
| D017437 |
| Skin and Connective Tissue Diseases |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D013729 | Terpenes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |
| D013812 | Therapeutics |
| D003879 | Dermatologic Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D011838 | Radiation-Sensitizing Agents |
| D003131 | Combined Modality Therapy |
| D004358 | Drug Therapy |