A Randomized, Controlled Study to Evaluate the Sensitizing Potential of Diltiazem Hydrochloride 2% Cream in Healthy Subjects Using a Repeat Insult Patch Test Design

NCT01816529 Phase 1 UNKNOWN

The goal of this study will be to determine the potential of Diltiazem Hydrochloride 2% Cream to induce sensitization by repeated topical application to the skin of healthy subjects under controlled conditions.

Details

Lead sponsor	Ventrus Biosciences, Inc
Phase	Phase 1
Status	UNKNOWN
Enrolment	200
Start date	2013-03
Completion	2013-09

Conditions

• Diltiazem Skin Sensitivity.

Interventions

• Diltiazem Hydrochloride 2% Cream
• Vehicle Cream
• 0.1% solution of sodium lauryl sulfate (SLS)
• Saline (0.9%)

Primary outcomes

• Determine the potential of Diltiazem Hydrochloride 2% Cream to induce sensitization by repeated topical application to the skin of healthy subjects under controlled conditions. — 6 weeks after the first topical application
  A total cumulative irritation score for each subject and product will be calculated by summing each individual's scores on each of the 9 evaluation days in the Induction Phase. Cumulative irritancy during Induction will be quantified by means of the cumulative irritancy index (CII), defined as the mean of irritation scores received during the Induction Phase (9 readings). The determination of dermal sensitization potential will be based on specific scoring criteria derived from observations in the Challenge Phase of the study and confirmed in the Rechallenge Phase, if necessary. The recurrence of a cutaneous response at Rechallenge equivalent to or more severe than that observed at challenge will be considered indicative of a sensitization reaction. The observation of such a response in even a single subject suggests that the test product may have the potential to cause hypersensitivity.

Countries

United States