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 @ 4:50 PM
Ignite Modification Date:
2025-12-24 @ 4:50 PM
NCT ID:
NCT06729450
Eligibility Criteria:
Inclusion Criteria:
1. Male or female subject aged 18 years or older, at screening visit.
2. Subject with clinical diagnosis of acne vulgaris on the face as defined by Investigator's Global Assessment (IGA) score of 2 (Mild) or 3 (Moderate), with the same score on both sides of the face.
3. Subject with a symmetrical number of lesions on the whole face.
4. The subject is a female of childbearing potential is willing to undergo UPTs throughout the study.
5. Subject having read, understood, and signed the approved Informed Consent Form (ICF) prior to any participation in the study.
6. Subject agrees and is able to comply with all time commitments and procedural requirements of the protocol.
7. Subject agrees to having facial photographs taken and verified by the subject signing an approved photography ICF.
8. Subject is informed of terms pertaining to personal information protection and privacy and is willing to share personal information and data, as verified by signing a written authorization form.
Exclusion Criteria:
1. Subject with acne types other than acne vulgaris.
2. Subject with dermal conditions on the face that may interfere with study assessments in the opinion of the investigator (tattoo, skin abrasion, eczema, sun burn, scars, large nevi, etc.).
3. Subject with excessive facial hair that would interfere with study assessments, as judged by the investigator.
4. Pregnant women (positive urine pregnancy test at screening or baseline) or women planning pregnancy during the study.
5. Subjects taking Vitamin A supplements in excess of the recommended daily allowance (4000-5000 IU; no washout period is required).
6. Subject with a washout period for topical treatment or procedures on the face less than:
1. Topical treatments: corticosteroids, antibiotics, azelaic acid, alpha hydroxy acids, salicylic acid, zinc containing treatments, hydroquinones, and other anti-acne treatments - 2 weeks
2. Topical retinoids - 2 weeks
3. Calascoterone cream 1% - 2 weeks
4. Cosmetic/aesthetic procedures (e.g., comedo extraction, desquamating, or abrasive agents, adhesive "pore" cleansing strips) - 1 week
5. Wax epilation - 2 weeks
6. Photodynamic therapy - 4 weeks
7. Laser therapy, microdermabrasion, deep chemical peel, and other plastic surgical treatments for acne - 12weeks
7. Subject with a washout period for systemic treatment less than:
1. Corticosteroids (except locally acting such as inhaled or intrathecal), antibiotics, and spironolactone - 4 weeks
2. Oral retinoids/isotretinoin - 12 weeks
3. Cyproterone acetate/Chlomadinone acetate - 12 weeks
4. Immunomodulators - 12 weeks
8. Subject is currently receiving any prescription testosterone therapy or on a testosterone booster or supplements.
9. The subject is unwilling or unable to refrain from use of prohibited medication or procedures during the study.
10. Subject who will experience intensive ultraviolet exposure during the study (sunbathing, tanning beds, etc.).
11. Subject with an acute/chronic disease or a history of major medical, surgical, or psychiatric condition or surgical interventions that may interfere with the interpretation of the study results.
12. Study site personnel or employees/close relatives of the study Sponsor.
13. Subject who has participated in another investigational treatment study within 30 days prior to screening.
14. Subject with a history of alcohol/drug abuse.
15. Subject who is unable to communicate or cooperate with the investigator due to language problems or impaired cognitive/verbal function.
16. Subject is currently incarcerated.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06729450
Study Brief:
Protocol Section:
NCT06729450