Clinical Trial: Clinical Evaluation of Lyral® Dose Response Study

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

Official Title: Clinical Evaluation of Hydroxyisohexyl 3-cyclohexene Carboxaldehyde (Lyral®) Dose Response Study

Brief Summary: The purpose of this study is to compare ascending doses of investigational T.R.U.E. Test allergens to the marketed petrolatum reference allergen.

Detailed Summary: This is a single-center, double-blind, randomized study to compare the diagnostic performance (primary) and safety (secondary) of ascending doses of hydroxyisohexyl 3-cyclohexene carboxaldehyde (Lyral®) 0.40 - 0.20 - 0.10 mg/cm²and a control patch (ß-cyclodextrin and Povidone (PVP)), in 20 adult subjects who have a clinical history of contact dermatitis and have tested positive (current or previous patch test) to Lyral® or Fragrance Mix 2.
Sponsor: Allerderm

Current Primary Outcome:

• Percentage of Participants who exhibit Positive Responses to each Allergen Concentration [ Time Frame: 3-21 days following application ]
  Subjects were patch tested with one experimental T.R.U.E. Test allergen panel containing 0.40 mg/cm^2, 0.20 mg/cm^2, and 0.10 mg/cm^2 of Lyral® and a negative control and a second panel containing the marketed reference allergen (20 mg of Lyral® 5%, in petrolatum). The panels were worn for approximately 48 hours. Skin reactions were assessed at 3, 4 and 21 days following application. A response is considered positive if it is graded 1+ (erythema, infiltration, discrete papules), 2+ (erythema, papules, infiltration, discrete vesicles) or 3+ (coalescing vesicles, bullous eruption) during at least one post removal visit.
• Percentage of Participants who exhibit Negative, Doubtful or Irritant Responses at Day 3, Day 4 and Day 21 [ Time Frame: 3-21 days following application ]
  Subjects were patch tested with one experimental T.R.U.E. Test allergen panel containing 0.40 mg/cm^2, 0.20 mg/cm^2, and 0.10 mg/cm^2 of Lyral® and a negative control and a second panel containing the marketed reference allergen (20 mg of Lyral® 5%, in petrolatum). The panels were worn for approximately 48 hours. Skin reactions were assessed at 3, 4 and 21 days following application. Negative responses are graded no response, doubtful responses include faint macular or homogenous erythema with no infiltration and irritant responses include discrete, patchy, follicular, or homogenous erythema with no infiltration.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Percentage of Participants who exhibit Irritation (tape reaction), Itching and/or Burning Resulting from Application of the Investigational and Reference Allergen Panels [ Time Frame: Day 2: 48 hours after application ]

  Tape irritation is graded on a 4 point scale: None (no tape irritation), Weak (faint to definite pink), Moderate (moderate erythema, definite redness) and Strong (severe erythema, very intense redness). Percentage of response will include weak, moderate and strong reactions.

  Itching and Burning are graded on a 4 point scale: None (no discomfort), Weak (minimal discomfort), Moderate (definite discomfort) and Strong (significantly bothersome, possible interference with sleep or daily activity). Percentage of response will include weak, moderate and strong responses.

• Percentage of Subjects who exhibit Late or Persistent Reactions [ Time Frame: Days 2-21 ]
  Late reactions initially occur at 7-10 days after application of the panels Persistent reactions appear at Day 2-4 and persist through Day 7-21

Original Secondary Outcome: Same as current

Information By: Allerderm

Dates:
Date Received: January 2, 2014
Date Started: February 2013
Date Completion:
Last Updated: January 3, 2014
Last Verified: January 2014