Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-24 @ 11:40 PM
NCT ID:
NCT00025051
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Fitzpatrick type I-IV skin
* No history of photosensitivity (e.g., systemic or discoid lupus erythematosus, polymorphous light eruption, or photocontact dermatitis)
* No history of abnormal tanning responses or other unusual reactions to natural or artificial light sources
* Willing to wear sun-protective clothing and SPF 15-49 sunscreen
* Willing and able to restrict the frequency of high ultraviolet-exposure activities (e.g., exposure to sunlight, tanning boxes, or other artificial light sources)
* No history of keloid formation
PATIENT CHARACTERISTICS:
Age:
* 20 to 60
Performance status:
* Not specified
Life expectancy:
* Not specified
Hematopoietic:
* WBC ≥ 3,500/mm\^3
* Hemoglobin ≥ 12.0 g/dL
* No bleeding disorder
Hepatic:
* Bilirubin ≤ 20% above upper limit of normal (ULN)
* AST and ALT ≤ 20% above ULN
* No chronic or acute hepatic disease
Renal:
* Creatinine ≤ 20% above ULN
* No chronic or acute renal disease
Gastrointestinal:
* No active gastrointestinal disease (e.g., inflammatory bowel disease)
* No pancreatic disease
* No esophageal, gastric, pyloric channel, or duodenal ulceration
Other:
* No invasive cancer except nonmelanoma skin cancer cured by excision or stage I cervical cancer
* No hypersensitivity or adverse reactions to NSAIDs, salicylates, cyclo-oxygenase-2 (COX-2) inhibitors, or sulfonamides
* No condition that would preclude the use of NSAIDs
* No clinically significant laboratory abnormalities
* No medical or psychosocial condition that would preclude study participation
* Not pregnant or nursing
* Negative pregnancy test
* Fertile participants must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No concurrent chemo-immunotherapy
Chemotherapy:
* See Biologic therapy
* At least 1 year since prior chemotherapy, including topical fluorouracil
Endocrine therapy:
* At least 2 weeks since prior topical glucocorticoids
* At least 30 days since prior systemic corticosteroids
* No concurrent systemic glucocorticoids (inhaled corticosteroids allowed)
* No concurrent topical corticosteroids
* No concurrent hormonal therapy
* Hormone replacement (e.g., estrogen or thyroid replacement) allowed
Radiotherapy:
* No concurrent radiotherapy
Surgery:
* Not specified
Other:
* At least 14 days since prior aspirin (\> 100 mg/day) or other non-steroidal anti-inflammatory drugs (NSAIDs) taken at least 3 times per week
* At least 2 weeks since prior topical alpha hydroxy acids (e.g., glycolic acid or lactic acid)
* At least 6 months since prior oral retinoids (3 months for topical retinoids to the face)
* At least 30 days since prior treatment for esophageal, gastric, pyloric channel, or duodenal ulceration
* At least 30 days since prior investigational medication
* No other concurrent investigational medication
* No concurrent topical vitamin A derivatives and/or alpha hydroxy acids
* No concurrent immunosuppressive drugs
* No concurrent topical medication to the skin, including prescription and over-the-counter preparations (moisturizers and emollients allowed)
* No concurrent lithium, fluconazole, or warfarin
* No concurrent chronic NSAIDs (\> 3 times per week for \> 2 consecutive weeks per year)
* Concurrent cardioprotective doses of aspirin (≤ 100 mg/day) allowed
* Concurrent acetaminophen allowed
* No concurrent green tea consumption of \> 2 cups per day
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
60 Years
Study:
NCT00025051
Study Brief:
Protocol Section:
NCT00025051