GCP Organization Office | Shanghai Dermatology Hospital Clinical Trials Organization

PG-011 Gel for the Treatment of Mild to Moderate Atopic Dermatitis in Adolescents
   Clinical research project recruiting subjects la!

1.Project Introduction
We are conducting a randomized, blinded, excipient-controlled Phase I clinical study to evaluate the safety, tolerability, efficacy, and pharmacokinetic profile of PG-011 Gel after single and multiple administrations in adolescent subjects with mild-to-moderate atopic dermatitis (Protocol No. PG-011-AD-102). The study has been approved by the State Drug Administration (SDA). The study has been approved by the State Drug Administration and has been approved by the Ethics Committee of our hospital. If you or your friends or relatives fulfill the following conditions, you may have the opportunity to participate in this clinical trial.

2.Recruitment Requirements
Recruitment Population:
Adolescents with mild to moderate atopic dermatitis
Inclusion Criteria:
①Adolescent subjects ≥12 and <18 years of age, male or female.
② Subjects who meet the Williams criteria for the diagnosis of atopic dermatitis.
(iii) Those with a history of atopic dermatitis ≥6 months prior to screening and stable disease (defined as no incremental or decremental increase or decrease in cumulative lesion area of atopic dermatitis in the 28 days prior to baseline, by questioning)
④ An Investigator's Global Assessment (IGA) score of 2 (mild) or 3 (moderate) at the Screening and Baseline Visit
⑤ Skin lesion area (excluding scalp, but including facial lesions) as a percentage of body surface area (%BSA) at screening and baseline visit is 5% to 25
(vi) Agree to discontinue all medications used for the treatment of atopic dermatitis from screening to the final follow-up visit
(vii) Volunteer to participate in the clinical study and cooperate with the doctor to complete all the examinations and related data.

3. Enrollment
If you are interested in learning more about this study, please contact the following study doctors. The study doctor will confirm whether you are eligible to participate in this study based on your specific situation. Your participation in this study is voluntary and you will be asked to sign an informed consent form before the study begins.
Contact Person: Ms. Wang
Contact: 15941577282
Contact Address: Shanghai Dermatology Hospital (Baode Road Campus)