The Effect of Topical Imipramine on Pain and Effectiveness of Topical Photodynamic Therapy

Actinic Keratosis Clinical Trial

Official title:

Pilot Studies Testing the Effect of Topical Imipramine on Pain and Effectiveness of Topical Photodynamic Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05688904
• Other study ID #: 07286
• Status: Recruiting
• Phase: Phase 1
• 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
• 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

Related Conditions & MeSH terms

• Actinic Keratosis
• Keratosis
• Keratosis, Actinic
• Photodynamic Therapy

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