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 @ 4:58 PM
Ignite Modification Date:
2025-12-24 @ 4:58 PM
NCT ID:
NCT04631250
Eligibility Criteria:
Inclusion Criteria:
* Patients with a clinical diagnosis of acne vulgaris on the face
* Acne lesions include inflammatory papules/ pustules/ nodules and cysts , and non-inflammatory open and closed comedones.
* Acne refractory to conventional therapies
* Patients who are unable or do not want to take oral isotretinoin
* Patients who cannot tolerate isotretinoin
Exclusion Criteria:
* History of oral retinoid use within 12 months of study entry
* Systemic antibiotics within 6 month of study entry
* Topical acne treatment within 1 month of study entry
* Presence of any other skin disease that could interfere with the assessment of the acne, such as folliculitis or rosacea
* Presence of any other systemic disease that could affect the acne severity by its presence, such as polycystic ovarian syndrome, or by any medication prescribed for the treatment of the systemic diseases (retinoids, antibiotics).
* Pregnancy or intention to get pregnant
* lactating woman
* Porphyria
* Photosensitive dermatoses
* Allergy to any component of the photosensitizer compound
* Personal history of melanoma or dysplastic nevi
* A beard or other facial hair that might interfere with study assessments;
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
14 Years
Maximum Age:
40 Years
Study:
NCT04631250
Study Brief:
Protocol Section:
NCT04631250