Facial wrinkles
Conditions
Interventions
High-energy group:(1) One side of the face is randomly selected to receive high-energy IPL-AOPT treatment, while the other side receives placebo-level energy IPL-AOPT treatment
(2) both sides of the face receive botulinum toxin type A injections at the same dose.
Low-energy group:(1) One side of the face is randomly selected to receive low-energy IPL-AOPT treatment, while the other side receives placebo-level energy IPL-AOPT treatment
(2) Both sides of the face receive the same dose of botulinum toxin type A injection.
Placebo-level energy group:(1) Both sides receive placebo-level energy IPL-AOPT treatment
Sponsors
Eye & ENT Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
25 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1.Age and Sex: Subjects aged 25 to 55 years, with no restriction on sex. 2.Skin Condition: Presence of bilateral, symmetrical, visible dynamic and static facial wrinkles (including crow’s feet and forehead lines), with wrinkle severity reaching at least the mild level according to the prespecified grading scale; the skin condition on both sides of the face should be relatively symmetrical, with no obvious unilateral scarring, severe inflammation, or deformity. 3.Skin Type: Fitzpatrick skin types II to IV. 4.General Health Condition: Generally in good health, with no severe dysfunction of major organs such as the heart, lungs, liver, or kidneys. 5.Previous Treatments: Within 6 months prior to enrollment, subjects must not have received any facial botulinum toxin injections, dermal fillers (including hyaluronic acid and poly-L-lactic acid), autologous fat injections, or treatment with energy-based devices such as lasers, intense pulsed light, ultrasound devices, Thermage, or radiofrequency lifting devices. Subjects must also not have undergone any facial surgery or invasive procedures with long-term effects on skin structure, such as deep ablative laser resurfacing or facelift surgery. 6.Medication Use: Within 6 months prior to enrollment, subjects must not have used oral or topical retinoids (such as isotretinoin). Subjects must not require long-term oral administration of medications known to cause significant photosensitivity reactions (such as certain tetracyclines or thiazide diuretics), unless such medications can be discontinued during the study period without affecting control of the underlying disease. 7.Cooperation and Compliance: Subjects must be able to understand the purpose and procedures of the study, be willing to comply with the required follow-up visits at 6, 12, and 24 months, and agree not to undergo any other treatments that may affect facial wrinkles or skin quality during the treatment and follow-up periods. 8.Reproductive Considerations: Female subjects must be neither pregnant nor breastfeeding. Subjects with childbearing potential must agree to use reliable contraception during the study period.
Exclusion criteria
Exclusion criteria: 1.A clear history of hypersensitivity to any botulinum toxin preparation or its excipients (such as human serum albumin), or a history of severe adverse reactions. 2.Presence of photosensitive disorders (such as systemic lupus erythematosus or porphyria), or a confirmed history of photosensitizing medication use that cannot be discontinued; active skin infection (bacterial, viral, or fungal) or inflammatory dermatoses such as eczema or psoriasis in the treatment area. 3.Obvious scarring, severe nodulocystic acne, or severe hyperpigmentation/hypopigmentation on one side of the face, resulting in marked asymmetry of the skin condition between the two sides. 4.Concurrent uncontrolled severe cardiovascular disease (such as recent myocardial infarction or refractory hypertension), severe respiratory disease, active hepatitis, or significant hepatic or renal insufficiency; presence of malignant tumors or other serious diseases associated with a limited life expectancy. 5.Severe psychiatric disorders (such as uncontrolled depression or schizophrenia), cognitive impairment, or very poor compliance preventing cooperation with follow-up and assessment; subjects with a clear tendency toward body dysmorphic disorder or unrealistic expectations regarding cosmetic outcomes, as judged by the investigator to be unsuitable for participation. 6.Women who are pregnant or breastfeeding, or who plan to become pregnant during the study period and are unwilling to use effective contraception. 7.Any other condition that, in the opinion of the investigator, renders the subject unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in wrinkle score changes on both sides; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective skin parameters; | — |
Countries
China
Contacts
Public ContactHua Tong
Eye & ENT Hospital, Fudan University
Outcome results
None listed