NCT03319251 is a clinical trial in Actinic Keratosis, sponsored by The Cleveland Clinic.

Who is sponsoring NCT03319251?

NCT03319251 is sponsored by The Cleveland Clinic.

What condition does NCT03319251 study?

NCT03319251 studies Actinic Keratosis.

Is NCT03319251 still recruiting?

NCT03319251 is currently completed. Last updated 14 November 2023.

Last reviewed 2023-11-14 · How we verify

NCT03319251

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Biomarker Database Registry for Photodynamic Therapy

Completed Last updated 14 November 2023

What this trial tests

trial in Actinic Keratosis in 137 participants. Completed in 31 October 2023.

Timeline

6 October 2017

Primary endpoint
31 October 2023

31 October 2023

Quick facts

Lead sponsor	The Cleveland Clinic
Status	Completed
Study type	OBSERVATIONAL
Enrollment	137
Start date	6 October 2017
Primary completion	31 October 2023
Estimated completion	31 October 2023
Sites	1 location across United States

Conditions studied

Actinic Keratosis — all drugs for Actinic Keratosis →

Sponsor

The Cleveland Clinic

Who can join

18 and older, any sex, with Actinic Keratosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this research is to obtain a blood sample from patients with actinic keratoses undergoing routine Photodynamic Therapy, in order to measure biomarkers that are relevant to VitD and 5FU metabolism and might be predictive of PDT outcome. The biomarkers to be examined include serum VitD levels at the time of PDT, and the presence/absence of gene alleles that correlate with expression of several proteins involved in VitD and 5FU metabolism. The presence of these biomarkers will be correlated to the improvement in AK lesion counts at the patient's routine follow-up visit 3 months after PDT treatment.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Significant improvement of facial actinic keratoses after blue light photodynamic therapy with oral vitamin D pretreatment: An interventional cohort-controlled trial.
Bullock TA, Negrey J, Hu B, Warren CB, et al · · 2022 · cited 28× · PMID 35314199 · DOI 10.1016/j.jaad.2022.02.067
Vitamin D and Other Differentiation-promoting Agents as Neoadjuvants for Photodynamic Therapy of Cancer.
Maytin EV, Hasan T. · · 2020 · cited 25× · PMID 32077114 · DOI 10.1111/php.13230
Significant Association of Poly-A and Fok1 Polymorphic Alleles of the Vitamin D Receptor with Vitamin D Serum Levels and Incidence of Squamous Cutaneous Neoplasia.
Bullock TA, Mack JA, Negrey J, Kaw U, et al · · 2023 · cited 11× · PMID 36813159 · DOI 10.1016/j.jid.2023.01.028
Sandpaper curettage: A simple method to improve PDT outcomes for actinic keratosis.
Heusinkveld LE, Bullock TA, Negrey J, Warren CB, et al · · 2022 · cited 6× · PMID 35932960 · DOI 10.1016/j.pdpdt.2022.103050

Verify or expand the search:

Other recruiting trials for Actinic Keratosis

Currently open trials in the same condition.

NCT06778434 — The Effect of Topical Imipramine on Photodynamic Therapy-Mediated Immunosuppression on Forearms or Face on US Veterans · Phase 2 · recruiting
NCT05699603 — Testing the Efficacy of Topical Calcipotriene Plus 5-Fluorouracil Combination to Activate the Immune System Against Prec · Phase 2 · active not recruiting

Other The Cleveland Clinic trials

Trials by the same sponsor.

NCT07218198 — Clinical Decision Support Tool for the Treatment of Uncontrolled Hypertension · NA · not yet recruiting
NCT07442747 — Neural Mechanisms of Aerobic Exercise Benefits in PD With DBS · NA · not yet recruiting
NCT07471464 — Centered Surgery - Preoperative Counseling and Patient Satisfaction · recruiting
NCT07073963 — Virtual Patient Groups for Sarcoidosis Associated Fatigue · NA · recruiting
NCT07363343 — Nifedipine and Enalapril vs Nifedipine and Labetalol for the Treatment of Postpartum Hypertension Study · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03319251 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by The Cleveland Clinic
Last refreshed: 14 November 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03319251.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing