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 @ 10:36 PM
Ignite Modification Date:
2025-12-24 @ 10:36 PM
NCT ID:
NCT01276535
Eligibility Criteria:
Inclusion Criteria:
* signed informed consent form.
* male or female.
* 18 to 40 years.
* area sought for acne reduction is the face.
* diagnosis of moderate or severe acne vulgaris, defined as grade 3-5 according to the grading criteria of acne severity given by Burton et al.
* Acne has been ongoing for at least 3 months prior to screening and must include inflammatory lesions.
* female using hormonal birth control must have been on a stable dose for at least 3 months prior to screening.
* negative pregnancy test for female subjects, unless the female subject has been surgically sterilized.
* sexually active female subject who is not surgically sterile or 2 years post menopausal must agree to use approved contraception/birth control measure while on study
* PI (A normal healthy patient) or P2 (A patient with mild systemic disease) on the American Society of Anesthesiologists (ASA) Physical Status Classification System.
* subject agrees to abstain from use of non-study treatments for acne while enrolled in the study.
* subject agrees to abstain from use of tanning beds/sunbathing while partaking in the study.
* subject agrees, and be able, to maintain regular medication schedule, as is medically feasible, during study participation.
* subject agrees to not change skin care regimen throughout study participation.
* subject is willing and able to comply with all requirements of the study protocol.
Exclusion Criteria:
* use of topical acne treatment within 15 days prior to start of study.
* use of oral acne treatment within 30 days prior to the start of study.
* use of oral isotretinoin or other systemic retinoids in the 12 months preceding the start of the study.
* use of systemic steroids within 30 days prior to the start of the study.
* pregnancy or currently nursing, or planning pregnancy during the course of the study
* participation in any clinical study involving an investigational product within 30 days of the start of the study
* use of tanning beds or sunbathing in the 30 days prior to the start of the study.
* history of keloids or other photosensitive disorders or use of any photosensitizing medication.
* currently taking any medication that may alleviate or exacerbate acne.
* Porphyria or known allergies to porphyrins.
* current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease.
* known malignancy or history of malignancy other than non-melanoma skin cancer
* human immunodeficiency virus (HIV), hepatitis B or hepatitis C
* signs of bacterial, fungal or viral skin lesions that may interfere with assessment of acne vulgaris.
* known inherited or acquired coagulation defects.
* substance abuse (drug or alcohol) problem within the previous 3 years.
* developmental disability or cognitive impairment that may preclude study compliance.
* unlikely to comply with the study protocol and procedure administration protocol, or is considered unsuitable for participation in the study for any other reason in the opinion of the investigator.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT01276535
Study Brief:
Protocol Section:
NCT01276535