Clinical Evaluation of the Photoallergy Potential of Xenaderm Ointment
This study has been completed.
Sponsor:
Healthpoint
Information provided by:
Healthpoint
ClinicalTrials.gov Identifier:
NCT00645164
First received: March 24, 2008
Last updated: June 1, 2010
Last verified: June 2010
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| Tracking Information | |||||
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| First Received Date ICMJE | March 24, 2008 | ||||
| Last Updated Date | June 1, 2010 | ||||
| Start Date ICMJE | March 2008 | ||||
| Primary Completion Date | May 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Frequency Distribution of Skin Irritation Scores [ Time Frame: 48-hours post irradiation ] [ Designated as safety issue: Yes ] Scores based on skin irritation scale of 0 (no reaction) to 7 (large vesiculo-bullous reaction) in whole units. Photoallergic reactions were characterized by irritation scores of 3 or higher. |
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| Original Primary Outcome Measures ICMJE |
Skin reaction score [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ] | ||||
| Change History | Complete list of historical versions of study NCT00645164 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Clinical Evaluation of the Photoallergy Potential of Xenaderm Ointment | ||||
| Official Title ICMJE | Clinical Evaluation of the Photoallergy Potential of Xenaderm Ointment | ||||
| Brief Summary | The product is being tested to see if exposure to light causes photoallergic reactions on the skin. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 | ||||
| Study Design ICMJE | Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) |
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| Condition ICMJE | Healthy | ||||
| Intervention ICMJE |
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| Study Arm (s) | Experimental: Xenaderm
Subject serves as own control
Interventions:
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 59 | ||||
| Completion Date | June 2008 | ||||
| Primary Completion Date | May 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00645164 | ||||
| Other Study ID Numbers ICMJE | 011 101 09 002 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | H. B. Slade, MD, Healthpoint | ||||
| Study Sponsor ICMJE | Healthpoint | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Healthpoint | ||||
| Verification Date | June 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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