Exceptional Clinical Research for Skin Care Innovation
30+ years of expertise | 100+ protocols annually | Regulatory-ready results
Why Choose KGL?
KGL Skin Study Center has been the trusted partner for pharmaceutical companies, cosmetic brands, and personal care product manufacturers since 1984. Our unique combination of speed, reliabilty, and expertise makes us the preferred choice for clinical research in skin care.
Founded in 1984 by clinical pioneers Kays H. Kaidbey, MD, Gary L. Grove, PhD, and James J. Leyden, MD, our center is built on a foundation of academic and scientific excellence. We are fully GCP compliant, maintaining internal compliance officer oversight and established SOPs for every operational process. Furthermore, we provide FDA-ready documentation and regulatory submission support that is recognized and accepted by agencies worldwide.
Our research is led by board-certified dermatologists on staff who provide expert clinical evaluation for all ongoing studies. We utilize advanced technology and automated systems, including SkinSkor EDC and Allegro CTMS, to maintain the highest levels of efficiency and data quality. With decades of experience, we deliver proven endpoints and validation data that support reliable, reproducible results for our partners.
KGL Skin Study Center ensures rapid study activation by leveraging a massive volunteer database of over 1 million potential participants located within 15 minutes of the facility. We provide a block enrollment guarantee to ensure timely study initiation, while our use of electronic IRB submissions significantly reduces administrative delays. With over 100 protocols executed annually, our team demonstrates a proven track record of capacity and on-time delivery for every project.
Our Research Services
Our robust clinical research platform incorporates outcomes and photography to support claims substantiations for cosmetic, consumer products, over-the-counter and prescription drugs and devices for the skin. Types of claims typically substantiated by KGL include:
- Dermatologist Tested
- Clinically Tested
- Allergy Tested
- Hypoallergenic
- Skin Types Desirability
- Non-Irritating
- Non-Stinging
- Non-Photosensitizing
- Formulated for Sensitive Skin
- Reduction of Fine Lines / Wrinkles
- Skin Brightening, Lightening or Smoothing
- Cleanses & Moisturizes
- Noncomedogenic / Non-Acnegenic
- Anti-Inflammatory
- Anti-Itch
KGL conducts a variety of repeat insult patch testing (RIPT) for assessing safety and tolerability for use on human skin. Many of which were developed by the founder of KGL, Dr. Albert M. Kligman. These types of studies remain the industry standard for new ingredient and product testing:
- Allergenicity
- Photosensitivity
- Irritancy
- Acnegenicity/Comedogenicity
- Pruritus
- Cell Turnover
KGL’s large database and board-certified medical specialists makes us well suited for conducting phase II through IV clinical trials in diverse populations and study types
- Aging Skin
- Eczema/Atopic Dermatitis
- Acne
- Rosacea
- Psoriasis
- Vitiligo
- Warts /Molluscum
- Aesthetic Devices and Injectables
Small studies to demonstrate efficacy and/or safety prior to large scale testing are often useful starting points in commercial development. KGL has experience in designing and conducting proof of concept studies for a wide array of indications with both novel and customizable endpoints. Skin biopsy tissue acquisition provides analysis for:
- Histology
- Immunohistochemistry
- DNA, RNA, Protein
- Microbiology
Our Process: Design to Delivery
We manage every aspect of your clinical study from initial concept through final reporting.
Phase I: Design & Development
We work closely with you to design studies that meet your specific research objectives and regulatory requirements. Our team brings decades of experience to ensure your study is positioned for success from day one.
Concept and Trial Design
- Consultation on study objectives and optimal design approach
- Endpoint selection based on product claims and mechanism of action
- Subject inclusion/exclusion criteria development
- Timeline and feasibility assessment
Protocol Development
- Comprehensive study protocols meeting GCP standards
- Visit schedules and assessment timing optimized for endpoints
- Detailed procedural instructions for study staff
- Amendment management as needed throughout study
Informed Consent Form Development
- Clear, compliant ICFs meeting all regulatory requirements
- Age-appropriate language for pediatric studies
- IRB-ready formatting and content
- Translation services available when needed
Budgeting
- Transparent, itemized cost breakdown
- Competitive pricing with no hidden fees
- Milestone-based payment schedules
- Cost-per-completed-subject options available
Phase II: Study Conduct & Management
Our experienced team manages every operational detail of your study, from regulatory submissions through final data delivery. We leverage advanced technology and rigorous quality control to ensure reliable, audit-ready results.
Electronic IRB Submissions
- Fast-track submission to our partnered IRB
- Complete regulatory documentation package
- IRB correspondence management and amendment processing
- Average approval time: 2-3 weeks
Rapid Recruitment
- Fully trained recruitment staff dedicated to subject screening and enrollment
- Large in-house database with 1M+ potential subjects within a 15-minute drive from philadelphia
- Advanced search algorithms to match subjects to study criteria
- Multi-channel recruitment (phone, email, text, mail)
Block Enrollment
- 100% accrual guarantee – we've never failed to fully enroll
- Concentrated enrollment windows minimize study timeline variability
- eConsenting platform for efficient, compliant consent process
- ADP@aline Pre-paid debit cards for subject compensation – fast, convenient, trackable
- Talksoft automated appointment reminder calls reduce no-shows and improve retention
Qualified Professional & Support Staff
- Board Certified Dermatologists serve as Principal Investigators and provide expert clinical evaluation
- Clinical Research Coordinator manages day-to-day study operations and serves as sponsor point of contact
- Experienced study staff trained in GCP and study-specific procedures
- Multi-specialty medical consultants available (pediatrics, allergy, ophthalmology, dentistry, gynecology)
Reliable Endpoints
- Expert Graders – trained and validated for consistent, reproducible assessments
- Supervised Treatments at our facility or at-home with compliance monitoring
- Photography – standardized imaging with controlled lighting and positioning for before/after comparisons
- Non-invasive instrumentation – corneometry, chromametry, profilometry, sebometry, TEWL, ultrasound
- Self-assessments – patient-reported outcomes and satisfaction questionnaires
- Decades of validation data supporting our methodologies
SkinSkor EDC Electronic Data Capture
- Paperless data collection at point of care
- Built-in quality checks and edit checks prevent errors
- Real-time data availability for sponsors via secure portal
- Complete audit trail for regulatory compliance
- Customizable for any study design
Adverse Events Management and Reporting
- Real-time AE tracking and documentation
- Immediate dermatologist assessment of all events
- Timely reporting to sponsors and IRB per regulatory requirements
- Safety monitoring throughout study duration
Product Accountability
- Secure product receipt, storage, and dispensing
- Temperature monitoring and documentation
- Chain of custody tracking
- Destruction and return documentation
Cloud-based Allegro® Clinical Trial Management System (CTMS)
- Randomization – automated, secure treatment assignment
- Data entry, verification and confidentiality – secure web-based access for authorized users
- CRF completion – electronic case report forms with built-in validation
- Biostatistics – Ph.D.-level statisticians perform all analyses
- Final Reports – electronic and hard copy delivery, regulatory-ready format
How To Get Started
Your Path to Partnering with KGL:
Schedule a no-obligation consultation to discuss your needs.
Receive custom protocol, budget, and timeline within 1-2 weeks.
We handle everything and deliver results on time.
Ready to Begin Your Research?
Partner with KGL for reliable, compliant clinical testing backed by 40 years of expertise.
