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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05688904
Other study ID # 07286
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date January 19, 2023
Est. completion date March 2028

Study information

Verified date April 2024
Source Wright State University
Contact Manager, Clinical Research Operations
Phone 937-245-7500
Email pturesearch@wrightstatephysicians.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is testing the use of topical Imipramine in combination with topical photodynamic therapy's (PDT) effect on pain following treatment. PDT is a commonly used treatment in dermatology for patients who have many pre-cancers (actinic keratosis-AKs) on their skin. These are both FDA-approved treatments, but this study is evaluating their use in combination, which has not been evaluated in the past. The investigators have been doing studies using animals that suggest that imipramine might make the PDT less painful and might help it work better. In order to participate, the subject and their dermatologist have decided that they would benefit from PDT to treat their skin due to many AK precancerous lesions. Please note that neither PDT nor imipramine are experimental treatments, but treating their skin with imipramine before PDT is a new approach.


Recruitment information / eligibility

Status Recruiting
Enrollment 24
Est. completion date March 2028
Est. primary completion date March 2028
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Male or female ages 18 and older - Skin type must be "Fair", Fitzpatrick type I to III, due to the presence of actinic damage in this population. - Subjects need to have a physician's order to receive PDT treatment on their face, scalp or forearms. - Willing to participate and understand the informed consent document. - Willing to avoid excess sun exposure/tanning beds to the area to be treated with PDT. Exclusion Criteria: - Those currently taking any tricyclic antidepressants (TCAs) - Those currently taking any selective serotonin reuptake inhibitor (SSRI) - Those with porphyria - Large tattoos in the treated areas - Pregnancy or nursing - Taking any oral or topical medications that could interfere with the PDT (Appendix A) - Active rashes in the area

Study Design


Intervention

Drug:
Imipramine
Topical 4% Imipramine
Other:
Vehicle
Vehicle

Locations

Country Name City State
United States Wright State Physicians Fairborn Ohio

Sponsors (1)

Lead Sponsor Collaborator
Wright State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of precancerous actinic keratosis present from baseline. Principal investigator assesses this from AK lesion count mapping at baseline and in 6 months. 6 months post PDT treatment
Secondary Change in pain level due to photodynamic therapy (PDT) from baseline. The visual analog pain scale is used to assess this outcome. (0 = no skin pain to 10 = severe skin pain) Immediately post PDT treatment
Secondary Change in pain level due to photodynamic therapy (PDT) from baseline. The visual analog pain scale is used to assess this outcome. (0 = no skin pain to 10 = severe skin pain) 10 minutes post PDT treatment
Secondary Change in pain level due to photodynamic therapy (PDT) from baseline. The visual analog pain scale is used to assess this outcome. (0 = no skin pain to 10 = severe skin pain) 30 minutes post PDT treatment
Secondary Change in pain level due to photodynamic therapy (PDT) from baseline. The visual analog pain scale is used to assess this outcome. (0 = no skin pain to 10 = severe skin pain) 6 months post PDT treatment
Secondary Change in itch level due to photodynamic therapy (PDT) from baseline. The visual analog itch scale will be used to assess this outcome. (0 = no skin itch to 10 = severe skin itch) Immediately post PDT treatment
Secondary Change in itch level due to photodynamic therapy (PDT) from baseline. The visual analog itch scale will be used to assess this outcome. (0 = no skin itch to 10 = severe skin itch) 10 minutes post PDT treatment
Secondary Change in itch level due to photodynamic therapy (PDT) from baseline. The visual analog itch scale will be used to assess this outcome. (0 = no skin itch to 10 = severe skin itch) 30 minutes post PDT treatment
Secondary Change in itch level due to photodynamic therapy (PDT) from baseline. The visual analog itch scale will be used to assess this outcome. (0 = no skin itch to 10 = severe skin itch) 6 months post PDT treatment
See also
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Completed NCT01449513 - PEP005 Gel - Biological Effects in Actinic Keratosis Assessed by Reflectance Confocal Microscopy Phase 1
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Completed NCT00989313 - A Long Term Follow up Study of Patients Who Have Complete Clearance of Their Actinic Keratosis (AK) Lesions at the Day 57 Visit in the PEP005-028 Study Phase 3
Completed NCT00306800 - Metvix PDT Versus Vehicle PDT With Aktilite CL128 Lamp in Patients With Actinic Keratosis on the Face and Scalp Phase 3
Completed NCT00375739 - Study to Determine the Safety of PEP005 0.025% and 0.05% Topical Gel in Patients With Actinic Keratoses Phase 2
Completed NCT03285490 - A Multi-Center Study to Evaluate the Efficacy and Safety of KX2-391 Ointment 1% on Actinic Keratosis on Face or Scalp (AK004) Phase 3
Completed NCT03319251 - Biomarker Database Registry for Photodynamic Therapy
Completed NCT02866695 - Safety and Efficacy of Ingenol Mebutate Gel 0.015% for Treatment of AK on the Face in Solid Organ Transplant Recipients Phase 4
Completed NCT02952898 - Study Comparing GDC 695 and Diclofenac Sodium Gel, 3% in Subjects With Actinic Keratoses Phase 3
Completed NCT02984072 - Menthol for PDT Pain Relief Phase 4
Recruiting NCT03684772 - Topical Ionic Contra-Viral Therapy in Actinic Keratosis Phase 2
Completed NCT02938715 - Pilot Study of the Pragmatic Use of Mobile Phone Based Follow up of Actinic Keratoses Treated With Topical 5-fluorouracil N/A
Completed NCT02878382 - Potential Impact of Patient Vitamin D Status in AK Response to MAL-PDT N/A