💬In plain words
What the trial is, and whether it could suit you
The goal of this exploratory clinical trial is to characterize and compare skin clinical signs, skin physiology and subjective well-being before and after CO₂ fractional laser or Thermage treatment. It will also explore correlations between skin parameters and investigate the optimal timing for starting skincare products after the procedure. The main questions it aims to answer are:
* How do skin clinical signs, physiological indicators and subjective well-being change pre- and post-procedure for CO₂ fractional laser and Thermage?
* Are there correlations between different skin parameters before and after the aesthetic procedure?
* When is the optimal time to begin using skincare products after treatment?
Researchers will compare CO₂ fractional laser versus Thermage. Clinical assessors remain blinded to treatment group assignment; participants are unblinded due to visible procedural ef
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
* 1\) Asian women, with age range from 30 to 59 years old;
* 2\) Be in general good health and good mental state;
* 3\) Presenting healthy skin as determined by Dermatologist;
* 4\) All Fitzpatrick skin types;
* 5\) All skin types on face (dry, normal, oily and combination) by subjects' self-perceived, with sensitive skin status confirmed and documented by a dermatologist;
* 6\) Facial skin exhibits specific characteristics (the mean baseline needs to be the same for 2 groups for all those parameters, before the pre-treatment phase T-2w) which require dermatological evaluation, detailed as follows: Crow's feet wrinkles: grade: 3≤ grade ≤5 (SKIN AGING ATLAS, page 40 to 41) Underneath eyes wrinkles: 3≤ grade ≤6 (SKIN AGING ATLAS, page 46 to 47) Ptosis of the lower part of the face: 1≤ grade ≤3 (SKIN AGING ATLAS, page 66 to 67) Lack of firmness: 3≤ grade ≤6 (9-point scale, 0 is the worst, 9 is the best) Pigmentary spots: 3≤ grade ≤5 (SKIN AGING ATLAS, page 79 to 81) (only for CO2 fractional laser Group)
* 7\) Willing to participate in one session of aesthetic procedure, either Fractional Ultrapulse CO₂-laser or Thermage procedure, after a 2-week wash-out period, followed by a 10-day self-recovery observation period.
* 8\) Aware and willing to accept that after a 10-day healing period, if the skin is not "ready" for the application of cosmetic products as determined by a dermatologist, they will be required to withdraw from the study;
* 9\) Have clean testing area (face): free of make-up on face, free of skin care products (lotions, sunscreens), make-up, perfumes, or other topical products on the visit day;
* 10\) Not currently be participating and will not participate in any other study involving the test area (face) for the duration of the study;
* 11\) Not have participated in any other study involving the test area (face) in the past 1 month;
* 12\) Be willing to read, understand and able to sign the Informed Consent Form \& Photo Release Form;
* 13\) Be willing to comply with all study protocol requirements.
Exclusion Criteria:
* 1\) Intending to get pregnant, be pregnant, be lactating, be within 6 months of delivery or be unwilling to take necessary precautions to avoid a pregnancy;
* 2\) Have any skin problems to impact clinical assessment, such as large areas of acne, scars, and open wounds, etc.;
* 3\) Having used antihistamine drugs in the past 1 week and one month after the treatment or immunosuppressants in the past 1 month;
* 4\) Take anti-allergic drug/injections in the past 1 month;
* 5\) Presently have allergies, allergic dermatitis or skin disease;
* 6\) Have sensitivity or even allergy to topical products, ingredients or fragranced products;
* 7\) Having a history of allergies, including but not limited to allergies to certain ingredients in cosmetics.
* 8\) Have history of suffering from skin diseases (such as psoriasis, eczema, psoriasis, skin cancer, etc.);
* 9\) Have used any anti-inflammatory treatment on the test area within 2 months prior to this study starting date;
* 10\) Has a chronic medical condition that may interfere with testing (e.g., asthma, insulin-dependent diabetes, lupus, rheumatoid arthritis or other immune/auto-immune diseases);
* 11\) Have received cosmetic medical procedures on the face (such as injectable anti-wrinkle products, cosmetic surgery, tattoo removal, home light facial procedures or home use medical devices, etc.) in the past 6 month; For Thermage group: priority screening for fillers, thread lifts, and metallic implants in the treatment area; For CO2 fractional laser Group: priority screening for laser treatments, peeling procedures, isotretinoin treatmentrecently and risk of herpes simplex virus (HSV) reactivation and post-inflammatory hyperpigmentation (PIH);
* 12\) Have excessive sun exposure or ultraviolet light in the past 1 month;
* 13\) Have applied Alpha hydroxyl acid, ortho-hydroxybenzoic acid, hydroquinone in the past 3 months; or used prescriptions (such as antibiotic, retinoids, alpha hydroxyl acid and steroid), oral contraceptives (such as Diane 35®，Jasmine®，Holgyeme®，Syndi 35®，Regulon®);
* 14\) Avoid providing emergency contact;
* 15\) Subjects that are not compliant to the selection criteria or not proper for participation as determined by Principal Investigator;
* 16\) An employee of the cosmetic companies or Shanghai China-Norm Quality Technical Service Co., Ltd.
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