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NCT00591331 Clinical Trial

Phototoxicity Potential of NatrOVA Creme Rinse - 1%

Head Lice Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00591331
Other study ID # SPN-107-07
Secondary ID HTR 07-128384-11
Status Completed
Phase Phase 1
First received December 28, 2007
Last updated May 16, 2008
Start date December 2007
Est. completion date December 2007

Study information
Verified date December 2007
Source ParaPRO LLC
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 37
Est. completion date December 2007
Est. primary completion date December 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Spinosad (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.
• placebo

Locations
Country Name City State
United States Hill Top Research St. Petersburg Florida

Sponsors (1)
Lead Sponsor Collaborator
ParaPRO LLC

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety endpoint will be visual grading of UV irradiated test sites and assessments of adverse experiences 7 days Yes
See also
  Status Clinical Trial Phase
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Completed NCT00672971 - Safety and Efficacy Study to Compare a 4% Dimethicone Foam and Nix Cream Rinse (1% Permethrin) in the Control of Head Lice N/A
Completed NCT00858481 - A Pilot Dose Ranging Study of Spinosad Creme Rinse Phase 2
Completed NCT03301649 - Clinical Endpoint Study of Ivermectin 0.5% Lotion Phase 3
Completed NCT00995124 - Trial of the Ovicidal Activity of Three Head Lice Products (NeutraLice Lotion®, NeutraLice Advance® and Moov Head Lice Solution®) After a Single Application Phase 4
Completed NCT00994422 - Study Comparing the Safety and Efficacy of 0.5% Ivermectin Cream to Placebo in Lice Infested Subjects Phase 2
Completed NCT03337490 - A Clinical Endpoint Bioequivalence Study to Assess Efficacy and Safety of Ivermectin 0.5% Lotion in the Treatment of Head Lice Phase 3
Completed NCT06333054 - Safety and Efficacy of a Head Lice Shampoo N/A
Completed NCT02213055 - Pediatric Head Lice Study Product Comparison Phase 2
Completed NCT02974088 - Neem Lotion With Combing for Lice Phase 2
Recruiting NCT05379114 - Comparative Study for the Evaluation of a New Medical Device on the Treatment of Head Lice Infestation N/A
Completed NCT03617926 - A Clinical Trial to Evaluate Efficacy and Safety of a Water-soluble Head Lice Product. N/A
Completed NCT01803581 - A Study to Evaluate the Safety and Efficacy of Product X92001327 vs RID Shampoo in Subjects With Head Lice N/A
Completed NCT01066585 - A Safety and Efficacy Study Comparing 0.5% Ivermectin Cream to a Vehicle Control in Subjects With Head Lice Infestation Phase 3
Completed NCT01068158 - A Study Comparing the Safety and Efficacy of 0.5% Ivermectin Cream to Placebo in Lice Infested Subjects Phase 3
Completed NCT00857935 - A Safety and Efficacy Pilot Study Comparing NatrOVA Creme Rinse 1% and NIX Creme Rinse Phase 2
Completed NCT00301340 - Efficacy and Safety of Summers Non-Pesticide Lice Asphyxiator (L.A.)for the Treatment of Head Lice Phase 3
Completed NCT02061813 - Dermal Safety Study to Evaluate Potential Irritation of Abametapir Lotion Phase 1
Completed NCT02062073 - Dermal Safety Study to Evaluate the Sensitizing Potential of Abametapir Lotion Phase 1
Completed NCT00605956 - NatrOVA Photoallergy Study - NatrOVA Creme Rinse in Healthy Volunteers Phase 1

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