Breast Augmentation and Breast Reconstruction, Breast Reconstruction, Chemotherapy Effects, Hyperpigmentation, Hyperpigmentation; Melanin, Lymphatic Abnormalities, Skin Abnormalities, Skin Barrier to Water Loss, Skin Discoloration, Skin Health, Skin Irritation, Stretch Mark
Conditions
Keywords
aesthetic care healing modality, bbl post care treatment, breast augmentation and reconstructive post care treatment, stretch marks, skin hyperpigmentation, skin irritation, skin barrier health, skin discoloration
Brief summary
This clinical study evaluates a topical botanical formulation for supporting skin recovery following invasive and non-invasive aesthetic procedures. These procedures include liposuction, breast augmentation, Brazilian butt lift (BBL), laser treatments, and micro needling, pregnancy stretch mark and weight loss skin. The study will assess the effects of the formulation on skin elasticity, hydration, and overall appearance when used as part of post-procedure care under the supervision of licensed medical professionals. Participants will apply the product to treatment areas over a defined study period, and outcomes will be compared to a control group receiving standard care or placebo.
Detailed description
The investigational product is a topical botanical formulation composed of plant-derived extracts including Pyrus malus (apple) fruit extract, Vanilla planifolia fruit extract, Jasminum officinale (jasmine) flower extract, and Vitis vinifera derivatives. These components are commonly used in dermatologic and cosmetic applications for their antioxidant, emollient, and skin barrier-supporting properties. The formulation contains fatty acid components, including linoleic acid, which may contribute to maintaining skin hydration and barrier integrity. The product is intended for topical use following invasive and non-invasive aesthetic procedures, including liposuction, breast augmentation, Brazilian butt lift (BBL), laser therapies, and micro needling, pregnancy stretch mark and weight loss skin. This study is designed as a randomized, interventional clinical trial conducted in medical aesthetic clinics, dermatology practices, and med spa settings. Participants were assigned to either an intervention group receiving the investigational product for standard post-procedure usage for topical skincare use. Primary outcome measures include assessment of skin elasticity, hydration, and visible skin appearance. Secondary outcomes include time to visible recovery and incidence of adverse skin reactions.
Interventions
OTHERApple Peptide Complex Post-Aesthetic Care Protocol
Participants receive the Apple Peptide Complex topical formulation as a standardized post-aesthetic care intervention following invasive and non-invasive aesthetic procedures. Participants apply the formulation to designated treatment areas according to the protocol-defined frequency, amount, and duration. Outcomes are evaluated to assess the formulation's effects on post-procedural skin recovery and overall cellular repair. Apple Peptide Complex is administered topically as a standardized post-aesthetic care intervention following invasive and non-invasive aesthetic procedures. Participants apply the formulation to designated treatment areas according to protocol-defined instructions regarding frequency and duration. The study evaluates predefined outcomes associated with post-procedural recovery and overall cellular repair.
Sponsors
Grow Out Oils Clinical Aromatherapy Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
This study was conducted as an open-label trial. Both participants and investigators were aware of the assigned treatment groups due to the nature of the topical intervention and standard care comparison.
Intervention model description
Participants were randomized into two parallel groups: an intervention group receiving the topical Apple Peptide Complex as part of post-procedural care, and a control group receiving standard post-procedure care. Both groups were monitored over the same study period following invasive and non-invasive aesthetic procedures, including surgical and dermatologic treatments, to evaluate skin recovery outcomes.
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
Inclusion criteria
* Female participants aged 45-65 years * Undergoing or have undergone aesthetic or surgical procedures (e.g., liposuction, breast augmentation, laser treatments, microneedling) * Presence of skin concerns such as hyperpigmentation, scarring, or reduced elasticity * Willing and able to comply with study procedures and follow-up * Physician clearance for participation
Exclusion criteria
* Active skin infections, open wounds, or delayed wound healing * Pregnancy or breastfeeding * Use of conflicting topical or systemic treatments * Known allergy to botanical ingredients in the formulation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinician-Graded Visual Skin Evaluation Score | Baseline, Day 14, and Day 28 post-procedure | Clinician assessment of skin surface appearance to monitor reductions in post-procedural redness and dryness. Evaluation is performed using a standard 0 to 4 scale, where 0 indicates no redness/dryness and 4 indicates severe redness/dryness. Unit of Measure: Units on a scale (0 to 4) |
| Change in Trans epidermal Water Loss (TEWL) | 28 days post-procedure (with assessments conducted at day 14 and day 28) | Evaluation of skin barrier function following daily topical use of the cosmetic Apple Peptide Complex. Data are collected via a tewameter to assess absolute changes in skin moisture retention. Unit of Measure: g/h/m² |
| Participant Comfort Rating Score | Baseline, Day 14, and Day 28 post-procedure | Self-reported participant feedback regarding skin comfort, including soothing sensations and lack of irritation. Scores are recorded using a feedback scale from 0 (extreme discomfort/irritation) to 10 (complete skin comfort/highly soothed). Unit of Measure: Units on a scale (0 to 10) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Presence of Post-Inflammatory Hyperpigmentation (PIH)Description | Baseline (pre-procedure), immediately post-procedure, Day 14, and Day 28 | Clinical observation of the treated area to identify the development of post-procedural hyperpigmentation. Unit of Measure: Percentage of participants with observed hyperpigmentation. |
| Clinician-Graded Skin Desquamation Score | Baseline (pre-procedure), immediately post-procedure, Day 14, and Day 28 | Assessment of skin flaking or peeling in the treated area using a standard clinical scaling chart. Evaluation is graded on a 0 to 4 scale, where 0 indicates no desquamation and 4 indicates severe desquamation. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORShanna Bynes Bradford, Master Aromatherapy
Grow Out Oils Clinical Aromatherapy Company
STUDY_DIRECTORDr. Lane Rolling MD, Virologist, Epidemiologist,
Outcome results
None listed