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NCT Number: NCT05688904

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

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.

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Key information

Conditions

Imipramine Actinic Keratosis Keratosis Keratosis, Actinic Neoplasms Photodynamic Therapy Precancerous Conditions Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Wright State Physicians

Fairborn, Ohio, 45324, United States

Location status: Recruiting

Location contact

Pharmacology Translational Unit

CONTACT

937-245-7500

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Imipramine

Drug

Topical 4% Imipramine

Vehicle

Other

Vehicle

Primary outcomes

  1. Number of precancerous actinic keratosis present from baseline.

    Time frame: 6 months post PDT treatment

    Principal investigator assesses this from AK lesion count mapping at baseline and in 6 months.

Secondary outcomes

  1. Change in pain level due to photodynamic therapy (PDT) from baseline.

    Time frame: Immediately post PDT treatment

    The visual analog pain scale is used to assess this outcome. (0 = no skin pain to 10 = severe skin pain)

  2. Change in pain level due to photodynamic therapy (PDT) from baseline.

    Time frame: 10 minutes post PDT treatment

    The visual analog pain scale is used to assess this outcome. (0 = no skin pain to 10 = severe skin pain)

  3. Change in pain level due to photodynamic therapy (PDT) from baseline.

    Time frame: 30 minutes post PDT treatment

    The visual analog pain scale is used to assess this outcome. (0 = no skin pain to 10 = severe skin pain)

  4. Change in pain level due to photodynamic therapy (PDT) from baseline.

    Time frame: 6 months post PDT treatment

    The visual analog pain scale is used to assess this outcome. (0 = no skin pain to 10 = severe skin pain)

  5. Change in itch level due to photodynamic therapy (PDT) from baseline.

    Time frame: Immediately post PDT treatment

    The visual analog itch scale will be used to assess this outcome. (0 = no skin itch to 10 = severe skin itch)

  6. Change in itch level due to photodynamic therapy (PDT) from baseline.

    Time frame: 10 minutes post PDT treatment

    The visual analog itch scale will be used to assess this outcome. (0 = no skin itch to 10 = severe skin itch)

  7. Change in itch level due to photodynamic therapy (PDT) from baseline.

    Time frame: 30 minutes post PDT treatment

    The visual analog itch scale will be used to assess this outcome. (0 = no skin itch to 10 = severe skin itch)

  8. Change in itch level due to photodynamic therapy (PDT) from baseline.

    Time frame: 6 months post PDT treatment

    The visual analog itch scale will be used to assess this outcome. (0 = no skin itch to 10 = severe skin itch)

Study contacts

Contact information is provided by the study sponsor or research team.

Manager, Clinical Research Operations

CONTACT

[email protected]

937-245-7500

Regulatory Specialist

CONTACT

[email protected]

937-245-7500

Sponsors and collaborators

Lead sponsor

Wright State University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Jan 18, 2023
Registry last updated
Apr 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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