Clinical TrialID 3736
Topical Perillyl Alcohol in Treating Patients With Sun Damaged Skin and Actinic Keratoses
NCT00608634
Precancerous Condition
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 3736
- Evidence Id
- 3736
- Core Evidence Id
- 3736
- Source Clinical Trial Id
- 3709
- Herb2 Clinical Trial Id
- HBCT003709
- Nct Id
- NCT00608634
- Title
- Topical Perillyl Alcohol in Treating Patients With Sun Damaged Skin and Actinic Keratoses
- Status
- Completed
- Phase
- Phase 2
- Study Result
- Yes
- Study Condition
- Precancerous Condition
- Study Type
- Interventional
- Study Design
- Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
- Intervention
- DRUG: perillyl alcohol|OTHER: placebo
- Intervention Allocation
- Randomized
- Intervention Model
- Parallel
- Intervention Mask
- Quadruple
- Intervention Purpose
- Treatment
- Gender
- All
- Age
- Adult, Older_Adult
- Enrollment
- 89
- Outcome Measure
- Change in Histopathology Score of Sun Damaged Skin by Treatment Group, The histopathologic scoring for skin biopsies from sun-damaged skin to assess the following seven characteristics: 1- atypia (levels 0, 1 \& 2), 2- inflammation (grades 0, 1 \& 2), 3- hyperkeratosis (loss of basket weave pattern of stratum corneum), 4- parakeratosis (present when there were \>3 characteristic nuclei per 40:1 field in stratum corneum), 5- dyskeratosis (focal presence of cells with homogenous, pink cytoplasm n pyknotic nuclei), 6- epidermotropism (lymphocytes migration of \>3 cells into epidermis, 7- loss of granular layer. All assessments were done using a 40:1 objective., Baseline to 3 months
- Sponsor Collaborator
- University of Arizona|National Cancer Institute (NCI)|Arizona Disease Control Research Commission
- Funded By
- OTHER
- Location
- Arizona Cancer Center at University of Arizona Health Sciences Center, Tucson, Arizona, 85724-5024, United States
- Other Id
- CDR0000582634|P01CA027502|P30CA023074|UARIZ-HSC-04-27|UARIZ-POH-002
- Start Date
- 2004-05
- Primary Completion Date
- 2008-06
- Completion Date
- 2009-06
- First Posted
- 2008-02-06
- Results First Posted
- 2015-04-01
- Last Update Posted
- 2015-04-01
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT00608634
- Title Cn
- Title En
- Topical Perillyl Alcohol in Treating Patients With Sun Damaged Skin and Actinic Keratoses
- Bilingual Status
- semi_complete