Clinical Trial: Itch Relieving Effect of Botox: a Study in Healthy Subjects

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Itch Relieving Effect of Botox: a Study in Healthy Subjects

Brief Summary: The purpose of this study is to determine if Botox is effective in the treatment of an experimentally induced itch that mimics chronic itch in healthy volunteers.

Detailed Summary: Several studies have shown that botulinum toxin type A (BoNT/A) has an antipruritic effect due to the inhibition of acetylcholine and other pruritic factors, such as substance P and glutamate. For instance, subcutaneous BoNT/A improves itch accompanied to hand eczema, dermatitis, lichen simplex, and rhinitis. Furthermore, a double-blind, placebo-controlled study showed that BoNT/A reduced histamine itch intensity in healthy men. Since acetylcholine has been shown to mediate itch in atopic dermatitis, this study aims to test the itch relieving effect of BoNT/A on a non-histaminergic model for chronic itch. This non-histaminergic model using the plant cowhage induces itch by activating protease activated receptor 2 (PAR2) receptors, which play a role in the itch of atopic dermatitis, also making this model better suited to test the efficacy of BoNT/A to relive chronic itch.
Sponsor: Temple University

Current Primary Outcome:

  • Itch by VAS Itch Intensity at Baseline (Visit 1) [ Time Frame: Baseline (Visit 1) ]
    The primary endpoint is to test the antipruritic effect of Botox using an itch visual analog scale (VAS) intensity scale as an outcome measure. The itch VAS intensity scale ranges from a minimum of 0 (no itch - best) to a maximum of 10 (maximum itch - worst). Participants will rate itch intensity after itch is induced with cowhage.
  • Itch by VAS Itch Intensity at 1 Week (Visit 2) [ Time Frame: 1 week from Baseline ]
    The primary endpoint is to test the antipruritic effect of Botox using an itch visual analog scale (VAS) intensity scale as an outcome measure. The itch VAS intensity scale ranges from a minimum of 0 (no itch - best) to a maximum of 10 (maximum itch - worst). Participants will rate itch intensity after itch is induced with cowhage.
  • Itch by VAS Itch Intensity at 1 Month (Visit 3) [ Time Frame: 1 Month from Baseline ]
    The primary endpoint is to test the antipruritic effect of Botox using an itch visual analog scale (VAS) intensity scale as an outcome measure. The itch VAS intensity scale ranges from a minimum of 0 (no itch - best) to a maximum of 10 (maximum itch - worst). Participants will rate itch intensity after itch is induced with cowhage.
  • Itch by VAS Itch Intensity at 3 Months (Visit 4) [ Time Frame: 3 Months from Baseline ]
    The primary endpoint is to test the antipruritic effect of Botox using an itch visual analog scale (VAS) intensity scale as an outcome measure. The itch VAS intensity scale ranges from a minimum of 0 (no it

    Original Primary Outcome: Change in itch relief by VAS itch intensity reporting after 1 week, 1 month, and 3 months after treatment [ Time Frame: Baseline, 1 week, 1 month, 3 months ]

    The primary endpoint is to test the antipruritic effect of Botox using an itch visual analog scale (VAS) intensity scale as an outcome measure. Participants will rate itch intensity after itch is induced with cowhage.


    Current Secondary Outcome: Change in Heat Pain Relief by VAS Pain Intensity Reporting After 1 Week, 1 Month, and 3 Months After Treatment [ Time Frame: Baseline, 1 week, 1 month, 3 months ]

    A secondary endpoint is to see if Botox has a relieving effect on heat pain using a pain visual analog scale (VAS) intensity scale as an outcome measure. The pain VAS intensity scale ranges from a minimum of 0 (no pain - best) to a maximum of 10 (maximum pain - worst). Participants will rate pain intensity after pain is induced with a heat thermode.


    Original Secondary Outcome: Change in Heat Pain Relief by VAS Pain Intensity Reporting After 1 Week, 1 Month, and 3 Months After Treatment [ Time Frame: Baseline, 1 week, 1 month, 3 months ]

    A secondary endpoint is to see if Botox has a relieving effect on heat pain using a pain visual analog scale (VAS) intensity scale as an outcome measure. Participants will rate pain intensity after pain is induced with a heat thermode.


    Information By: Temple University

    Dates:
    Date Received: December 18, 2015
    Date Started: February 2016
    Date Completion:
    Last Updated: March 16, 2017
    Last Verified: March 2017