Phototoxicity Potential of NatrOVA Creme Rinse - 1%

ParaPRO

Status and phase: Completed; Phase 1

Conditions: Head Lice

Treatments: Drug: placebo; Drug: Spinosad (the active ingredient in NatrOVA)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00591331

HTR 07-128384-111

SPN-107-07

Details and patient eligibility

About

This study will evaluate the primary irritation potential of NatrOVA Creme Rinse - 1% in humans, after exposure to UV radiation.

Enrollment: 37 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Male or female subjects 18-65 years of age and in good health.
2. Fitzpatrick skin type I, II or III

Exclusion criteria

1. History of severe reactions from exposure to sunlight
2. Known allergies or sensitivities to adhesives in patches
3. Inability to evaluate the skin in and around the test sites
4. Diabetes requiring medication
5. Clinical significant skin disease
6. Asthma or other severe respiratory disease
7. Known immunological disorders such as HIV, AIDS, lupus,rheumatoid arthritis
8. History or current skin cancer
9. Mastectomy for cancer involving removal of lymph nodes draining the test sites
10. Epilepsy
11. Pregnancy, lactation, or planned pregnancy during study period
12. Chronic use of systemic antihistamine medication within 14 days of screening
13. Use of anti-inflammatory drugs within 2 days of Screening Visit 1
14. Currently receiving allergy injections
15. Use of immunosuppressive drugs
16. Topical drugs used at the test site within 7 days of Screening Visit 1
17. Current participation in any clinical trial
18. Participation in any patch test for irritation or sensitization or UV exposures within 4 weeks of study start
19. Use of any investigational drug therapy within 4 weeks of study start.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

37 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

NatrOVA Creme Rinse - 1%

Treatment:

Drug: Spinosad (the active ingredient in NatrOVA)

2

Experimental group

Description:

NatrOVA Creme Rinse Vehicle Only

Treatment:

Drug: Spinosad (the active ingredient in NatrOVA)

3

Placebo Comparator group

Description:

Blank patch

Treatment:

Drug: placebo