Total Skin & Beauty Dermatology Center

Research Department

Total Skin and Beauty Dermatology Center, PC has more than 25 years in conducting FDA-regulated clinical studies. Dr. Gary Monheit, Dr. James Krell, Dr. Melanie Appell, and Dr. Michele Hill conduct research studies of investigational medications and devices as well as clinical trials of currently approved products. They have been investigators in numerous national and international trials. The research conducted at Total Skin and Beauty Dermatology keeps us on the forefront of new products and devices in both therapeutic and cosmetic indications. This provides patients access to many exciting new products and procedures before they ever come to the marketplace.

The Research Team

With a team of dedicated and trained professionals, the physicians of Total Skin and Beauty Dermatology Center, PC provide exceptional completion of clinical trials in the cosmetic and therapeutic areas of dermatology.

Dr. Gary Monheit

Dr. Monheit has more than 25 years experience conducting FDA-regulated clinical trials in cosmetic dermatology and skin cancer research. He maintains certification in Good Clinical Practice and the Protection of Human Subjects through Collaborative Institutional Training Initiative.

Dr. James Krell

Dr. Krell specialized in psoriasis research and has more than 10 years experience in conducting FDA-approved clinical trials. He maintains certification in Protecting Human Research Participant through the National Institute of Health.

Dr. Melanie Appell

Dr. Appell has more than 20 years experience in conducting clinical trials in various therapeutic areas including, but not limited to, acne, atopic dermatitis, psoriasis, and hidradenitis suppurativa. She maintains training in Good Clinical Practice and the Protection of Human Subjects through Collaborative Institutional Training Initiative.

Dr. Michele Hill

Dr. Hill has clinical trial experience in acne, rosacea, and psoriasis and has been conducting trials for more than 5 years. She maintains certification through the National Institute of Health in Protecting Human Research Participants.

Heidi Neugent, PA

Heidi has 10 years experience as a Sub-Investigator for clinical trials in cosmetic and therapeutic indications. She maintains certification in Protecting Human Research Participant through the National Institute of Health.

Shelley Winzeler, PA

Shelly has been involved with clinical trials for 5 years as a Sub-Investigator in the areas of psoriasis, acne, atopic dermatitis, and rosacea.

Candi Nelson, BS, CCRC - Director of Clinical Research

Candi has a Bachelors Degree in Biology and has 10 years experience in all phases of clinical trials in dermatology from protocol development to study implementation. She became a Certified Clinical Research Coordinator through the Association of Clinical Research Professionals (ACRP) in 2006. Candi maintains certification in Good Clinical Practice and the Protection of Human Subjects through Collaborative Institutional Training Initiative and Protecting Human Research Participant through the National Institute of Health.

Courtney Lockley – Study Coordinator

Courtney has a Bachelors Degree in History and has 4 years of clinical trial experience. She is certified in Protecting Human Research Participants through the National Institute of Health and in Good Clinical Practice and the Protection of Human Subjects through Collaborative Institutional Training Initiative.

Dina Nolan – Research Administrative Assistant

Dina has been with the Research Department for 4 years. She maintains certification in Protecting Human Research Participants through the National Institute of Health and in Good Clinical Practice and the Protection of Human Subjects through Collaborative Institutional Training Initiative.

Information for Patients

Choosing to participate in clinical research is an important personal decision. Participation in a study is based on voluntary enrollment and a full understanding of what is involved in the study. Informed consent is a prerequisite for any study and includes fully understanding the risks and benefits of taking part in the study and the time it will take to participate.

To participate, patients must meet certain requirements that are different for each study. These inclusions and exclusions are not used to reject people personally but rather to identify appropriate participants and to keep them safe.

The research conducted by Total Skin and Beauty is reviewed by an Institutional Review Board (IRB) who reviews and approves every new study before it can begin, to ensure scientific rigor and to protect the rights and welfare of the study participants.

To take part, patients need to feel well informed, confident, and secure about participating. Speak to family members, doctors, researchers, and hospital staff to see if participation in clinical research is appropriate for you. View information on Total Skin and Beauty Dermatology's clinical research studies.

Additional information on clinical studies can be found at the governmental website www.clinicaltrials.gov or at the private website www.centerwatch.com.

Information for Health Professionals

Total Skin and Beauty Dermatology welcomes inquiries and referrals from physicians and other caregivers. For more information regarding specific clinical protocols, eligibility criteria, contact information, or referrals of potential study participants, or to contact research physicians or clinical coordinators you may select one of our current studies or contact the Research Office at (205) 380-6148.

Information for Industry Sponsors

Total Skin and Beauty Dermatology Center welcomes industry sponsors interested in collaborating in industry-initiated as well as investigator-initiated clinical studies. The interests of individual principal investigators are listed on this site, as are currently active clinical studies and protocols. For more information about potential collaborations, contact the Research Department at research@totalskinandbeauty.com or (205) 380-6148.

Current Studies

Acne Study

Do you or your child, 12 years and older, have a tough case of acne on your face and/or trunk? If so, Dr. Melanie Appell is conducting a research study that may offer some help.

In order to qualify, you must be 12-54 years old and have severe acne with large, hard, painful bumps on the face and/or trunk. While acne may affect other areas of the body, this study is only for acne affecting the face and/or trunk. You must be in good general health and willing to visit the office 9 times over a 24-week period. All participating pediatric subjects and a select subset of adult subjects will have x-rays performed at various intervals during the study.

Study drugs, visits with the dermatology staff and other required specialists, and payment for participation will be provided for those who qualify and enroll.

If you are interested in finding out more information about participating in this acne research study, please contact Dr. Appell's office at (205) 380-6148 or research2@totalskinandbeauty.com. You may also visit www.youracnestudy.com.

Psoriasis Study

Do you have plaque psoriasis?

Dr. James Krell is conducting a clinical research trial of an investigational combination of an oral medication with an injectable medication to test is it is safe and effective when used to treat moderate to severe plaque psoriasis.

You may be eligible to participate if you:

• Are at least 19 years old
• Have moderate to severe plaque psoriasis
• Have psoriasis affecting more than 10% of your body

Eligible participants may receive:

• Study-related physical examinations
• Study drugs
• Limited compensation for time and travel related to study

For more information, please contact Dr. Krell's office at (205) 380-6148 or research1@totalskinandbeauty.com.

Crow's Feet Wrinkle Study

Do you have crow's feet? If you do, you may be eligible to participate in a research study of an investigational drug that Dr. Gary Monheit is conducting.

To be in this study you must:

• Be between 18 and 65 years old and in good health
• Have crow's feet wrinkles (also called lateral canthal lines) on the outside of your eyes that are moderate to severe
• Not have had any surgeries or procedures on or near the crow's feet skin area
• Not have received botulinum toxin treatment (any type or brand)
• Not used prescription retinoid products (such as Retin-A) during the last 3 months
• Agree to not use any facial treatments (such as fillers) or undergo any facial procedures (such as laser treatments) or surgeries during the study
• Not be pregnant; planning a pregnancy during the study; and you must agree to use an effective method of birth control during the study if you are a female who could get pregnant

If you are interested in participating in this study or need more information, please contact Dr. Monheit's office at (205) 380-6148 or research@totalskinandbeauty.com.

Research Department Contact Information
Main Number: (205) 380-6148
Fax: (205) 380-6149