Photodynamic Therapy (PDT) With Levulan and Blue Light for the Treatment of Actinic Cheilitis

NCT02409732 | Completed Phase 4 Results

• 1 other identifier: D15043 28525
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety and efficacy of PDT with blue light and topical Levulan in the treatment of actinic cheilitis.

Conditions

Actinic Cheilitis

Keywords

Actinic cheilitis; Photodynamic therapy; Levulan; Blue light

Outcome Measures

Primary Outcomes (1)

• Number of Participants With a Change in Clearance From Baseline

  Clearance will be estimated clinically as minimal (0%-25%), mild (26%-50%), moderate (51%-75%), good (76%-99%), or complete (100%). Results will also be evaluated by comparing photographs before and immediately after treatments, and 12 and 24 weeks after the last treatment.

  Visit 2 (Baseline) to Visit 5 or 6 (Week 24 or 36)

Secondary Outcomes (4)

• Average Change in Participant Reported Pain

  Baseline to Week 36

• Average Change in Local Skin Reactions to Blue Light Treatment

  Baseline to Week 36

• The Number of Participants Who Developed a Local Skin Reaction to Blue Light Treatment: Vesiculation/Pustulation, Erosion/Ulceration, Crusting and Hyperpigmentation

  Baseline to Week 36

• Number of Participants With Adverse Events

  Baseline to Week 36

Study Arms (1)

PDT

EXPERIMENTAL

PDT with aminolevulinic acid hydrochloride (HCl) and blue light to the affected area of the lips every six weeks for up to three treatments

Drug: aminolevulinic acid hydrochloride; Procedure: Photodynamic therapy with blue light

Interventions

aminolevulinic acid hydrochloride DRUG

Also known as: Levulan, aminolevulinic acid HCl

PDT

Photodynamic therapy with blue light PROCEDURE

Also known as: PDT with blue light, PDT

PDT

Eligibility Criteria

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

You may qualify if:

• Must be able to understand and voluntarily sign an informed consent form
• Must be male or female ≥ 18 years of age at the time of consent
• Must be able to adhere to the study visit schedule and other protocol requirements
• Must have a diagnosis of actinic cheilitis by histopathological evaluation of biopsy specimen or clinical presentation

You may not qualify if:

• Inability to provide voluntarily consent or mentally incompetent
• Active herpes labialis lesions
• Subjects with any condition which places the subject at unacceptable risk if he/she were to participate in the study, or confounds the ability to interpret data from the study
• Subjects with any other skin condition that might affect the evaluation of the study disease
• Pregnant or breastfeeding female subjects
• Subjects who have used any investigational medication within one month prior to study entry
• Subjects who have been previously exposed to PDT and/or topical Levulan therapy for the treatment of actinic cheilitis
• Subjects who have used local therapy (e.g. cryotherapy) or topical treatment (e.g. 5% fluorouracil) within three months of study entry
• Subjects who have used an oral photosensitizing drug (e.g. Declomycin) within six months of study entry
• Subjects who are currently using photosensitizing agents (e.g. thiazides, tetracyclines, fluoroquinolones, phenothiazines, and sulfonamides) because of the risk of augmented photosensitivity
• Subjects who are frequently exposed to ultraviolet radiation (e.g. lifeguards, construction workers, frequent sunbed users, etc.)
• Subjects with a history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins, or photodermatosis
• Subjects with a known hypersensitivity to Levulan
• Subjects who are immunocompromised

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• DUSA Pharmaceuticals, Inc.: collaborator

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03766, United States

Location

Related Publications (2)

• Ribeiro CF, Souza FH, Jordao JM, Haendchen LC, Mesquita L, Schmitt JV, Faucz LL. Photodynamic therapy in actinic cheilitis: clinical and anatomopathological evaluation of 19 patients. An Bras Dermatol. 2012 May-Jun;87(3):418-23. doi: 10.1590/s0365-05962012000300011.

  PMID: 22714758 BACKGROUND

• Zaiac M, Clement A. Treatment of actinic cheilitis by photodynamic therapy with 5-aminolevulinic acid and blue light activation. J Drugs Dermatol. 2011 Nov;10(11):1240-5.

  PMID: 22052302 BACKGROUND

MeSH Terms

Conditions

Actinic cheilitis

Interventions

Aminolevulinic Acid; Photochemotherapy; Blue Light; 1-phenyl-3,3-dimethyltriazene

Intervention Hierarchy (Ancestors)

Levulinic Acids; Keto Acids; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy; Light; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Optical Phenomena; Radiation; Radiation, Nonionizing

Results Point of Contact

• Title: Dr. Michael Shane Chapman Section Chief of Dermatology
• Organization: Dartmouth-Hitchcock Medical Center

Michael.Shane.Chapman@hitchcock.org

603-650-3106

Study Officials

• Michael S Chapman, MD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician

Study Record Dates

• First Submitted: March 27, 2015
• First Posted: April 7, 2015
• Study Start: April 1, 2015
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: October 23, 2018
• Results First Posted: October 23, 2018

Record last verified: 2018-10

Locations

US (1)