Thermosensitivity of a Topical Palmitated Formulation of Capsaicin

Launched by CARILION CLINIC · Dec 9, 2022

Keywords

ClinConnect Summary

The study design will detect levels of patient dysesthesia in response to Capsadyn using a three-arm, group comparison. Capsadyn will be compared to an active control \[capsaicin alone (Cap)\], and to a placebo cream alone (PL). The design will use a double-blind for assignment of test article to the three arms. Both the test article administrator and patient will be blinded to test article identity. The test article will be packaged in a coded, white-label, jar with cotton swab applicator.

Participants. Participants for the clinical trial will be recruited through the Carilion Clinic Derm...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 35 to 75 years of age
• • Has two arms
• • Has intact, unscarred skin over forearms
• • Absence of any eczema, hyperkeratosis, scleroderma or other dermatological conditions afflicting the area of test article application that may interfere with absorption as determined by the PI.
• • Must agree to not wash forearms during the study period unless a highly uncomfortable burning sensitivity occurs.
• • Must be willing to use treatments blinded.
• • Must be willing and able to comply with protocol requirements for the duration of study participation, including answering VAS queries in good faith and as diligently as possible.
• Exclusion Criteria:
• • Younger than 35 and older than 75 years of age
• • No previous use of capsaicin products for 48 hours prior to time 0 (application) of test articles.
• • Any dermatological conditions that in the judgement of the study site investigator has the potential to disrupt skin integrity or alter sensory function on the forearms.
• • Any skin infection, skin irritation (e.g. poison oak), history of eczema, trauma or burn (including sunburn) on the forearms within 30 days preceding application of test article.
• • Any recent medical history of painful conditions, surgery, or injury involving or affecting the forearms that may impede skin sensitivity.
• • Use of any topically applied products at any location, including prescription or over-the-counter (OTC) analgesic creams/lotions/patches, non-steroidal anti-inflammatory drugs, counter-irritants, local anesthetics, steroids 24 hours prior to the application visit.
• • History or current substance abuse including alcoholism/alcohol abuse, as judged by the study site investigator.
• • History of hypersensitivity to capsaicin (i.e. chili peppers or OTC capsaicin products).
• • At least 30 days since prior topical medications to the skin of the forearms except for emollients or sunscreens.
• • No concurrent therapy that may interfere with clinical evaluations.
• • No concurrent enrollment in another clinical trial.