Phototoxicity Potential of NatrOVA Creme Rinse - 1%

Phase 1 Evaluation of the Phototoxic Potential of NatrOVA Creme Rinse - 1% in Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00591331

Enrollment

Registered

2008-01-11

Start date

2007-12-31

Completion date

2007-12-31

Last updated

2008-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head Lice

Keywords

Head Lice

Brief summary

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

Interventions

DRUGSpinosad (the active ingredient in NatrOVA)

This is a patch test in which the test material is applied to the patch and the patch applied to the skin.

DRUGplacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Safety endpoint will be visual grading of UV irradiated test sites and assessments of adverse experiences	7 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026