- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07296601
Expert Consensus on the Clinical Use of Skin Boosters: A Delphi-Based Recommendation Framework
This consensus research project aims to develop standardized, evidence-based recommendations for the clinical use of skin boosters in aesthetic dermatology. Despite their widespread adoption for improving skin hydration, texture, and dermal quality, current practice patterns vary significantly across clinicians and regions, with limited unified guidelines. Using a structured Delphi methodology, the study will gather expert opinions from dermatologists and aesthetic medicine specialists to achieve agreement on key aspects of skin booster therapy, including indications, patient selection, injection techniques, dosing protocols, product selection, treatment intervals, expected outcomes, and safety considerations.
The project seeks to establish practical, consensus-driven guidelines that can harmonize clinical practice, enhance treatment outcomes, and ensure patient safety. The final recommendations will serve as a reference framework for practitioners and contribute to the standardization of skin quality enhancement treatments.
Study Overview
Status
Conditions
Detailed Description
Skin boosters have become an increasingly popular modality in aesthetic dermatology due to their ability to enhance skin hydration, elasticity, texture, and overall dermal quality through minimally invasive intradermal injections. Despite their rapid integration into clinical practice, current approaches to skin booster therapy remain highly variable. Differences exist in product selection, injection depth, dosing regimens, treatment intervals, technique, indications, and safety monitoring. Moreover, the evidence base is still evolving, and most available data come from fragmented clinical studies or manufacturer-driven guidelines. As a result, there is a significant need for unified, expert-driven recommendations that can standardize practice, optimize patient outcomes, and minimize complications.
This research project aims to develop comprehensive, evidence-informed consensus guidelines for the use of skin boosters in aesthetic practice. The study will use a structured Delphi methodology to gather and synthesize the perspectives of leading dermatologists and aesthetic medicine specialists. Through multiple iterative rounds, experts will evaluate and rate a series of statements addressing key clinical domains including: appropriate indications; patient selection criteria; anatomical considerations; recommended injection depths and techniques; dosing strategies; frequency and number of treatment sessions; choice of products (e.g., HA-based, polynucleotides, bio-remodeling agents); combination therapies; expected outcomes; management of adverse events; and contraindications.
The consensus-building process ensures anonymity, reduces bias, and encourages equal participation among experts. Quantitative analyses (e.g., percentage agreement thresholds, median and interquartile range scoring) will be used to determine which statements achieve consensus. Statements not reaching agreement will be revised and re-evaluated in subsequent rounds until final consensus is achieved.
By the end of the project, the expert panel will produce clear, standardized, and clinically actionable recommendations that can be used globally or regionally to harmonize the use of skin boosters. These guidelines will support clinicians by improving the consistency and quality of care, informing training programs, guiding patient counseling, and reducing complication rates. Ultimately, the project aims to fill a critical gap in aesthetic dermatology literature by establishing a scientifically grounded, consensus-driven framework for safe and effective skin booster therapy
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Cairo, Egypt
- Venus Research Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Inclusion Criteria
Experts will be eligible to participate if they meet all of the following:
Board-certified dermatologist or aesthetic physician
With recognized qualification in dermatology, aesthetic medicine, plastic surgery, or related fields.
Minimum clinical experience
At least 5 years of experience performing aesthetic injectable procedures.
OR at least 3 years of consistent use of skin boosters in clinical practice.
Demonstrated expertise in skin booster therapy
Must have performed ≥100 skin booster procedures overall,
OR ≥20 sessions per year over the past 2 years.
Active clinical practice
Currently practicing in an aesthetic or dermatology clinic, medical center, or hospital.
Authorship or contribution to aesthetic/dermatology education (desirable but not mandatory)
Publications, lectures, workshop instruction, or conference involvement in aesthetics.
Ability to participate in Delphi rounds
Must agree to complete all survey rounds within the specified timeframe.
Must be fluent in the language used for the study (e.g., English or Arabic).
Willingness to provide informed consent
Voluntary participation with confidentiality maintained.
Exclusion Criteria:
- Less than the required experience
<5 years of aesthetic practice
OR insufficient hands-on experience with skin booster injections.
Limited familiarity with skin booster products or techniques
No regular use in the last 2 years.
Has not performed the minimum number of required procedures.
Industry conflict of interest
Direct employment by a company manufacturing skin booster products.
Significant financial relationship with a single product manufacturer that may bias responses.
Inability to commit to multiple Delphi rounds
Anticipated non-compliance or non-response in iterative rounds.
Non-clinical or administrative professionals
Those not actively practicing (e.g., retired, research-only positions, students, trainees).
Participation in a competing guideline project
Experts currently serving on another skin booster consensus panel to avoid duplication or bias.
Failure to provide informed consent
Declines participation or withdraws consent at any time.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Expert Panel
A cohort of dermatology and aesthetic medicine experts participating in a Modified Delphi process to develop consensus recommendations on skin booster use.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Degree of Consensus on Clinical Recommendations
Time Frame: 6-12 weeks
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Definition: The creation of a unified, evidence-informed set of recommendations on skin booster use. Measurement Method: Number of statements that reach consensus across all Delphi rounds. Completeness of guideline domains (indications, technique, dosing, safety, etc.). Outcome: A finalized recommendations document for clinicians. |
6-12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Implementation Readiness of Final Recommendations
Time Frame: 6-12 weeks
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Definition: Practicality and ease of applying the guidelines in real-world clinical settings. Measurement Method: Expert evaluation of feasibility (Likert scale). Assessment of clarity and actionability of statements. Outcome: Determines how applicable the recommendations are in routine practice. |
6-12 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Skin Booster-VenusRC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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