BridgeMD
New treatment option for Facial Aging
Official title Secretome Treatment for Facial Rejuvenation
ClinicalTrials.gov ID: NCT07227883
What this study is testing
- What it's testing
- Secretome treatment for facial rejuvenation
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 to 75. Healthy volunteers may be eligible.
You may be able to join if
- Male or Female
- Age: ≥30 and ≤ 75 at the time of consent.
- Fitzpatrick skin types I-V
- Moderate to very severe facial aging according to the SASSQ for the categories of elasticity, wrinkles, and skin roughness.
- Willing to refrain from cosmetic procedures throughout the study period (i.e. laser treatments, chemical peels, microneedling, dermal filler...
You likely can't join if
- Use of topical tretinoin, adapalene, tazarotene, hydroquinone, imiquimod, 5-fluorouracil, ingenol mebutate, concentrated hydrogen peroxide...
- Dermatologic diseases or conditions (e.g. atopic dermatitis, psoriasis, rosacea, seborrheic dermatitis, wounds, infections, irritation, sunburn...
- Starting to use or stopping the use of GLP-1 agonists, or planned weight loss or gain during the study period. people using GLP-1 agonists must be...
- History of keloid formation, hypertrophic scarring, or abnormal/delayed wound healing
- Previous medical aesthetic rejuvenation treatments on the face, such as chemical peel, dermabrasion, non-ablative or ablative resurfacing procedure...
- Treatment with neuromodulators in crow's feet or below mid-eye level within 4 months prior to baseline photography
See the full eligibility criteria
Who can join
- Male or Female
- Age: ≥30 and ≤ 75 at the time of consent.
- Fitzpatrick skin types I-V
- Moderate to very severe facial aging according to the SASSQ for the categories of elasticity, wrinkles, and skin roughness.
- Willing to refrain from cosmetic procedures throughout the study period (i.e. laser treatments, chemical peels, microneedling, dermal filler injections, neuromodulator injections below the mid-eye level [forehead and...
- Willing to use study support products as directed and will not introduce any new skin care or makeup products throughout the study period. people will be provided with a Skincare Kit: Cetaphil Gentle Skin Cleanser 20...
- Male people with facial hair must be willing to shave the morning of their treatments/follow-up visits.
- Willing to minimize sun/ultraviolet light exposure for the duration of the study, including all of the following: applying sunscreen daily, at least 15 minutes before going outside; wearing sun-protective clothing...
- Competent and willing to provide written, informed consent to participate in all study activities
- Willing and able to tolerate multiple injections and attend all study visits
- Negative urine pregnancy test result at the time of screening (if applicable)
- For female people of childbearing potential, must be willing to use an acceptable form of birth control control (oral contraceptives, hormonal implants, intrauterine device [IUD], hormonal injectables specifically for...
What rules you out
- Use of topical tretinoin, adapalene, tazarotene, hydroquinone, imiquimod, 5-fluorouracil, ingenol mebutate, concentrated hydrogen peroxide, diclofenac, vitamin C, alpha hydroxy acids, or photodynamic therapy (PDT) to...
- Dermatologic diseases or conditions (e.g. atopic dermatitis, psoriasis, rosacea, seborrheic dermatitis, wounds, infections, irritation, sunburn, windburn, etc.) in the treatment area that could interfere with the study...
- Starting to use or stopping the use of GLP-1 agonists, or planned weight loss or gain during the study period. people using GLP-1 agonists must be taking the drug for maintenance AND body weight must have been stable...
- History of keloid formation, hypertrophic scarring, or abnormal/delayed wound healing
- Previous medical aesthetic rejuvenation treatments on the face, such as chemical peel, dermabrasion, non-ablative or ablative resurfacing procedure, or face-lift with laser or other devices, up to 3 months prior to...
- Treatment with neuromodulators in crow's feet or below mid-eye level within 4 months prior to baseline photography
- Treatment with dermal fillers, collagen stimulators, fat injections or permanent fillers within the past 6 months prior to baseline photography.
- Patients using other anti-aging treatments/procedures/systemic medications or injections administered/prescribed by a medical professional before starting the study, if the investigator believes they will confound the...
- Heavy smoker (\>1 pack of cigarettes a day)
- Energy-based device (i.e., radiofrequency device treatments, microfocused-ultrasound device or other ultrasound-based device treatments, laser and light-based device treatments, microneedling) treatment in the treatment...
- Currently be taking isotretinoin (Accutane).
- people on an immunosuppressant or have an autoimmune condition (except stable, controlled Hashimoto's thyroiditis)
- Surgery (i.e., face lift, eyebrow lift, neck lift or lower rhytidectomy, liposuction, etc.) during the 12-month period prior to baseline photography
- Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study
- Severe active infection (e.g. HIV, HepB or C, UTI, etc.)
- Current or recent (within last 5 years) malignancy (except basal cell and squamous cell skin cancers as long as basal cell was not on the face)
- History of systemic chemotherapy or radiation within the last 5 years
- Continuous/daily use of nonsteroidal anti-inflammatory or Vitamin E, unless discontinued within 7 days before 1st treatment and only used as needed through the trial period.
- Anticipated pregnancy or trying to become pregnant in the next year
- Current anticoagulant therapy (heparins; factor Xa inhibitors; direct agents such dabigatran, rivaroxaban, apixaban, endoxaban and betrixaban; warfarin/coumarins). Low dose aspirin and omega-3 supplements allowed.
- Any other criterion based on the clinical judgment of the investigator may place the subject at risk or confound study results
- Unable or unwilling to comply with the requirements (i.e. removal of jewelry, makeup, facial hair) of the study protocol in the opinion of the Investigator.
- Subject has any disorder that may prevent compliance, such as a history of chronic alcohol or drug abuse, significant mental or nervous disorder or other illness that would, in the evaluator's opinion, interfere with...
The study team makes the final eligibility decision.
Where it's taking place
- Newport Beach, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 30 years to 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Newport Beach, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.