NatrOVA Photoallergy Study - NatrOVA Creme Rinse in Healthy Volunteers

ParaPRO

Status and phase: Completed; Phase 1

Conditions: Head Lice

Treatments: Drug: Blank Patch; Drug: NatrOVA Creme Rinse - 1%; Drug: NatrOVA Creme Rinse Vehicle Only

Study type: Interventional

Funder types: Industry

Identifiers

NCT00605956

SPN-108-08

HTR Study #07-128385-111

Details and patient eligibility

About

Photoallergic reactions are assumed to be due to a delayed cell-mediated hypersensitivity response that requires the presence of ultraviolet irradiation. The predictive procedure is, therefore, based on modification of the Repeated Insult Patch Test (Kaidbey, 1991). Duplicate sets of patches of test articles are used with exposure of only one set to UV radiation and subsequent evaluation of both sets for skin reactions in order to compare irradiated versus non-irradiated test sites.

Full description

The study consists of of following phases: screening, induction, rest, challenge, and re-challenge (if necessary). The study will be conducted as a randomized, evaluator-blind test design.

Enrollment: 65 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male or female subjects 18-65 years of age
• Has the ability to understand and has signed a written informed consent form and HIPAA authorization
• Females of childbearing potential must agree to use an adequate birth control
• Fitzpatrick (1988) skin type I, II, or III.

Exclusion criteria

• History of severe reactions from exposure to sunlight
• Known allergies or sensitivities to adhesives in patches, medical tape, or ingredients found in the test articles
• Inability to evaluate the skin in and around the test sites
• Diabetes requiring medication
• Clinical significant skin diseases which may contraindicate participation
• Asthma or any other severe respiratory disease requiring chronic medication
• Known immunological disorders such as HIV, AIDS, SLE and/or RA
• History, within the last six months, of current cancer, including skin cancer
• Mastectomy for cancer removal of lymph nodes draining test sites
• Epilepsy
• Pregnancy, lactation, or planning a pregnancy during the test period
• Chronic use of systemic antihistamine medication, or use within 14 days prior to Screening Visit
• Use of anti-inflammatory drugs (exception: acetaminophen and < 81 mg.day aspirin are permitted) within 2 days of Screening Visit
• Currently receiving allergy injections
• Currently taking or expecting to take any photosensitizing medications
• Use of immunosuppressive drugs
• Topical drugs used at the test sites within the last 7 days prior to screening
• Current participation in any clinical trial
• Participation in any patch test for irritation or sensitization or any test involving UV exposures within 4 wees of study start
• Use of any investigational therapy within the past 4 weeks.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

65 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

NatrOVA Creme Rinse - 1% Spinosad

Treatment:

Drug: NatrOVA Creme Rinse - 1%

2

Experimental group

Description:

NatrOVA Vehicle - no Spinosad

Treatment:

Drug: NatrOVA Creme Rinse Vehicle Only

3

Placebo Comparator group

Description:

Blank Patch

Treatment:

Drug: Blank Patch