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 @ 5:43 PM
Ignite Modification Date:
2025-12-24 @ 5:43 PM
NCT ID:
NCT03615768
Eligibility Criteria:
Inclusion Criteria:
* Male or female, aged 12-40 years old
* Diagnosis of Grade II-III acne vulgaris with Pillsbury grading system
* Provide written informed consent if the subject is aged 18 or older. Ages 12-17 should provide written assent and written informed consent from patient's parent or legal guardian.
Exclusion Criteria:
* Known hypersensitivity to adapalene, clindamycin hydrochloride, clindamycin phosphate, lincomycin or any ingredient of the study drug, or of allergic constitution
* Secondary Acne, such as occupational acne and steroid acne
* Has a dermatological condition of the face that could interfere with the clinical evaluations, such as sunburn, psoriasis, seborrheic dermatitis or eczema
* History of Crohn's disease, ulcerative colitis or antibiotic-associated colitis
* History of serious heart disease or hypertension
* Serious liver or kidney disease, AST or ALT more than twice the upper limit of normal, or Cr above normal
* Serious endocrine, hematologic or psychiatric disease
* Known immunocompromised conditions, or require long-term steroids or immunosuppressants
* Females who are pregnant, lactating, or not willing to use effective contraception
* Drug or alcohol abuse
* Used any topical acne treatment within 2 weeks
* Used any systemic retinoid, antibiotic or other acne treatment
* Used any investigational drugs or device within 3 months, or concurrently enrolled in another clinical trial
* Patient who the investigator deemed to be unsuitable for any reason
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
40 Years
Study:
NCT03615768
Study Brief:
Protocol Section:
NCT03615768