NatrOVA Photoallergy Study - NatrOVA Creme Rinse in Healthy Volunteers

An Evaluation of the Photoallergy Potential of NatrOVA Creme Rinse - 1% in Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00605956

Enrollment

Registered

2008-02-01

Start date

2008-01-31

Completion date

2008-02-29

Last updated

2008-08-04

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, NatrOVA Creme Rinse - 1% is intended for the treatment of head lice

Brief summary

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.

Detailed 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.

Interventions

DRUGNatrOVA Creme Rinse - 1%

NatrOVA Creme Rinse - 1% spinosad

DRUGNatrOVA Creme Rinse Vehicle Only

NatrOVA Creme Rinse Vehicle - no spinosad

DRUGBlank Patch

Blank Patch

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Visual grading of test site and assessments of adverse experiences	Evaluations over a 6 week period

Countries

United States

Outcome results

None listed

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