Clinical Research Department
Alisa Schweikl, RN, CRC
Shelly Olivieri

SKIN SURGERY MEDICAL GROUP, INC.
5222 BALBOA AVENUE, SIXTH FLOOR
SAN DIEGO, CALIFORNIA 92117
TEL: (858) 292-5101
FAX: (858) 627-0861

Clinical Research Department Resume

Tax ID # 95-3866256
(Updated 03/21/07)

July 2006 - Present

A Multi-Center, Randomized, Evaluator-Blind, Controlled Study of the Safety and Efficacy of Pre-Treatment and Post-Treatment with a System on Wound Healing and Cosmetic Appearance Following Electrodessication and Curettage of Truncal Superficial Basal Cell Carcinoma.

June 2006 - Present

A Multi-Center, Randomized, Double-Blind, Parallel Group Study to Demonstrate the Efficacy and Safety of a Combination of Topical Gels and the Vehicle in Subjects with Acne Vulgaris.

May 2006 - Present

A Randomized, Double Blind, Vehicle-Controlled Multi-Center Study of the Safety and Efficacy of Tradename Cream Versus the Vehicle Cream in the Treatment of Actinic Keratosis.

February 2006 - Present

A Phase 3, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Twice Daily Cream Versus Vehicle Cream in the Treatment of Psoriasis.

October 2005 - May 2006

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study Comparing Generic Cream USP, 1% to a Generic Cream USP, 1% and Both Active Treatments to a Vehicles Control in the Treatment of Tinea Versicolor.

July 2005 - May 2006

A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study Comparing Generic Cream, Trade Name Cream and Both Active Treatments to a Vehicle Control in the Treatment of Actinic Keratosis of the Face or Scalp.

June 2005 - Present

Open-label Safety and Pharmacokinetic Study of a Trade Name Cream for One, Two, or Three Treatment Cycles to Surface Areas Greater than 25 cm square with Actinic Keratosis.

March 2005 - August 2005

A Double-Blind, Randomized, Parallel-Group, Vehicle-Controlled, Multi-Center Study to Evaluate the Safety and Clinical Equivalence of a Generic Gel to a Trade Name Gel in the Treatment of Interdigital Tinea Pedis

December 2004 - May 2005

Evaluation of Pigmented Skin Lesions with a Device System

November 2004 - December 2005

A 52 Week Open Label Study of the Safety of a Topical Gel in the Treatment of Seborrheic Dermatitis

October 2004 - August 2005

A Multi-Site Open Clinical Study to Collect Biological Specimens and Phenotypic Data from a Large Cohort of Subjects for Inclusion in a Repository and Use in Genomics (from DNA and RNA), Serologic and Metabolic (from Serum) and Proteomic (from Protein) Research Studies

July 2004 - July 2005

A Phase IIIb, Open-Label Effectiveness and Safety Study of a Topical Cream in the Treatment of Actinic Keratosis

June 2004 - May 2005

A 6-Week Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel Group Study to Investigate the Efficacy and Safety of a Topical Cream in Patients with Mild to Moderate Chronic Hand Dermatitis, Followed by a 6-Week Open Label Phase to Assess the Safety of a Topical Cream

May 2004 - November 2004

A Double-Blind, Randomized, Vehicle-Controlled, Parallel Group, Multicenter Study to Assess the Efficacy and Safety of a topical gel product containing a Topical Gel in the Treatment of Seborrheic Dermatitis

April 2004 - August 2005

A Multicenter, Investigator-Masked, Randomized Safety and Efficacy Study of 12 Weeks Treatment with Oral Capsules Once Daily vs. an Injectable Administered Subcutaneously Once Weekly vs. Oral Capsules Administered Orally Once Daily Plus and Injectable Administered Subcutaneously Once Weekly Followed by a 12-Week Post Treatment Follow-Up Period in Patients with Moderate to Severe Psoriasis

April 2004 - March 2005

A Multicenter, Open-Label, Prospective Study to Evaluate the Effectiveness and Safety of an Injectable in the Treatment of Subjects with Psoriasis

April 2004 - December 2004

A Phase II, Vehicle-Cream-Controlled, Double-Blind, Randomized Study in Humans, To Evaluate the Safety and Efficacy of a Topical Cream in the Inhibition of Hypertrophic Scar Formation Due to Surgical, or Thermal Insult

March 2004 - February 2005

A Randomized Study Comparing the Safety and Efficacy of a Topical Cream Vs a Topical Cream in the Treatment of Actinic Keratosis

March 2004 - February 2005

A Phase III, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Once Daily Topical Gel Verses Gel Vehicle in the Treatment of Psoriasis

February 2004 - February 2005

The Safety and Efficacy of a Topical Cream in the Treatment of Basal Cell Carcinoma

February 2004 - September 2005

A Long Term Safety and Efficacy Study of a Fixed Combination of a Topical Gel in Subjects with Acne Vulgaris

July 2003 - December 2005

An Open-Label 18-Month Safety Study of a Topical Cream for the Treatment of Actinic Keratoses

July 2003 - March 2004

A Multi-Center, Investigator-Blind Clinical Trial to Assess the Safety and Efficacy of a Topical Gel as Compared to a Trade Name Cream, in the Treatment of Rosacea.

March 2003 - March 2004

A Safety and Efficacy Evaluation of a Topical Gel verses a Trade Name Cream in the Treatment of Mild to Moderate Acne Vulgaris.

December 2002 - July 2003

A 12-Week, Multicenter, Double-Blind, Randomized, Parallel-Design Study of a Topical Gel and Vehicle Control in Patients with Acne Vulgaris.

October 2002 - April 2004

A Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group Study to assess the Efficacy, Safety and Tolerability of a new Oral Formulation in patients with Onychomycosis of the Toenails.

September 2002 - March 2003

A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled Study of the Safety and Efficacy of a Foam verses a Cream in the Treatment of Seborrheic Dermatitis.

July 2002 - May 2003

A Phase II Randomized, Double-Blind Study to Evaluate the Dosing Concentration and Application Frequency of a Topical Gel in the Treatment of Mild to Moderate Psoriasis in Pediatric and Adult Subjects.

June 2002 - August 2004

Patient Examination with a Machine Vision Instrument.

November 2002 - February 2004

A Multi-Center, Randomized, Placebo-Controlled Phase II Study Evaluating the Effect of an Injectable Treatment Compared to Placebo in Patients with Psoriasis.

February 2002 - October 2002

The Safety and Efficacy of a Study Gel as Compared to Vehicle in the Treatment of Mild to Moderately Severe Acne Vulgaris.

January 2002 - June 2002

Staining and Hyperspectral Imaging of Discard Tissue Excised from Skin Lesions - A pilot Study.

October 2001 - September 2003

A Phase III Multi-center, Open-Label Safety Study of Oral Study Medication in Patients with Moderate to Very Severe Psoriasis treated for Up to One Year followed by a 12-Week Post-Treatment Follow-Up Period.

June 2001 - December 2001

A Phase II Vehicle- Controlled, Modified-Blind, Dose-Escalating Study to Assess the Safety and Efficacy of Topical Gel for the Treatment of Common Warts in Adults.

April 2001 - January 2002

A Phase II 12-Week, Multicenter, Double-Blind, Randomized, Parallel Design Study of a Topical Gel and Vehicle Control in Patients with Acne Vulgaris.

February 2001 - September 2001

A Phase II Vehicle-Controlled 12-Week, Multicenter, Double-Blind, Randomized, Parallel Study Comparing Study Cream and Topical Gel for the Treatment of Acne Vulgaris.

January 2001 - November 2002

A Phase III Vehicle-Controlled, Double-Blind Study To Assess the Safety and Efficacy of Study Cream for the Treatment of Superficial Basal Cell Carcinoma.

November 2000 - January 2002

A Phase II Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Dose-Response, Safety and Efficacy Study of 24 Weeks Treatment with Study Medication and 12 Weeks Post-Treatment Follow-up in Patients with Severe Nodulocystic Acne.

October 2000 - March 2002

A Phase II Multi-Center Prospective Randomized Controlled Clinical Trial of a Study Device Vs Secondary Intention Healing in the Treatment of Full-Thickness Clean Surgical Excision Wounds.

October 2000 - April 2002

Long Term (12 Month) Safety and Efficacy of Trade name in the Treatment of Cutaneous Melanosis of the Face (Melasma).

August 2000 - February 2001

A Phase III Multi-Center, Randomized, Investigator Masked, 4-Arm, Parallel Study Testing the Safety and Efficacy of a Study Medication in the Treatment of Patients with Cutaneous Melanosis of the Face (Melasma).

August 2000 - October 2001

A Phase III Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study to Determine the Therapeutic Equivalence of Two Study Medication Formulations in the Treatment of Interdigital Tinea Pedis.

August 2000 - January 2001

A Phase II Multi-Center, Double-Blind, Vehicle Controlled Study to Evaluate the Safety and Efficacy of a Study Medication in the Treatment of Tinea Cruris.

July 2000 - May 2003

A Phase II Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Multi-Center Study Assessing the Effects of Two Study Medications in the Improvement of Moderate to Severe Age-Related Skin Changes in Postmenopausal Women.

June 2000 - April 2001

A Phase II Multi-Center, One-Year Follow-up Study to Clinically Validate the Histologic Endpoint for Patients Who Have Completed the Previous Superficial Basal Cell Carcinoma Study.

June 2000 - April 2001

A Phase II Multi-Center, One-Year Follow-up Study to Clinically Validate the Histologic Endpoint for Patients Who Have Completed the Previous Nodular Basal Cell Carcinoma Study.

November 1999 - March 2000

A Phase II Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Bilateral Paired-Comparison Study of the Safety and Efficacy of a 1% Study Cream Applied Twice Daily for 3 Weeks in Patients with Atopic Dermatitis.

October 1999 - April 2000

A Phase III Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study of the Safety and Efficacy of a 1% Medicated Study Cream Applied Once Daily for 12 Weeks in Patients with Acne Vulgaris

July 1999 - February 2000

A Phase II Multi-Centered, Double Blind, Randomized, Parallel Group, Dose Response, Safety and Efficacy Study of 12 Weeks with Oral Medication and Four Weeks Post Treatment Follow Up in Patients with Severe Nodulocystic Acne, Which Includes a Dose Escalation of 2 Simultaneous Double-Blind, Randomized Cohorts and 2 Open-Labeled Cohorts (Stage II)

March 1999 - July 1999

A Phase IV Double-Blind, Vehicle-Controlled, Parallel Group Study of the Efficacy and Safety of a Study Medicated Cream Versus Vehicle Cream in Children with Ichthyosis Vulgaris

December 1998 - April 2000

A Phase II Study of 12 Week Dose Optimizing Trial Evaluating a 5% Medicated Cream and Vehicle Cream for the Treatment of Superficial Basal Cell Carcinoma.

December 1998 - May 2000

A Phase II Study of 12 Week Dose Optimizing Trial Evaluating a 5% Medicated Cream and Vehicle Cream for the Treatment of Nodular Basal Cell Carcinoma.

December 1998 - August 1999

A Phase II Multi-Centered, Double Blind, Randomized, Parallel Group, Dose Response, Safety and Efficacy Study of 12 Weeks with Oral Medication and Four Weeks Post Treatment Follow Up in Patients with Severe Plaque Psoriasis.

December 1998 - August 1999

A Phase II Multi-Centered, Double Blind, Randomized, Parallel Group, Dose Response, Safety and Efficacy Study of 12 Weeks with Oral Medication and Four Weeks Post Treatment Follow Up in Patients with Severe Nodulosystic Acne (Stage I).

August 1998 - July 1999

A Phase II Vehicle-Controlled Dose Ranging Study of 5% Medicated Topical Cream for the Treatment of Plantar Warts.

August 1998 - July 1999

A Phase II Vehicle-Controlled Dose Ranging Study of 5% Medicated Topical Cream for the Treatment of Common Warts.

June 1998 - September 1998

A Phase III Double-Blind, Active- and Placebo-Controlled Study of the Safety and Efficacy of a Medicated Foam in Treating Scalp Psoriasis

April 1998 - July 1998

A Phase III Multi-Centered Controlled, Double-Blind, Comparative Study of the Safety and Efficacy of a Medicated Cream and Their Vehicles in the Treatment of Facial Acne.

February 1998 - November 1998

A Phase III Open Label Study to Evaluate the Safety of a Topical Medicated Cream for the Treatment of Women with Excessive Facial Hair.

February 1998 - September 1998

A Phase IV Comparative Study for a Topical Gel in Combination with a Study Medicated Cream vs. a Study Medicated Cream Alone in the Treatment of Stable Plaque Psoriasis.

August 1997 - August 1998

A Phase III Double-blind Study to Evaluate the Safety and Efficacy of a Topical Medicated Cream in the Treatment of Tinea Pedis.

June 1997 - October 1997

A Phase III Open Label Study of the Safety and Efficacy of a Medicated Injectable Solution in Subjects with Moderate to Severe Atopic Dermatitis.

April 1997 - December 1998

Thalidomide for the Treatment of Erosive Lichen Planus.

April 1997 - May 1998

A Phase II Study of Combined Intralesional Recombinant Injectable Solution Therapy and Surgical Excision in Patients with Keloids.

March 1997 - June 1997

A Phase III Double-blind, Placebo-Controlled Study of the Efficacy and Safety of a Study Medicated Foam in Treating Scalp Psoriasis.

January 1997 - December 1997

A Phase III Open Label Study to Evaluate a Repeat Cycle Treatment Regimen Using a Medicated Injectable Gel in Patients with External Condylomata Acuminata.

December 1996 - August 1997

A Phase III Study Assessment of Efficacy and Patient Acceptance of a Medicated Topical Cream as Monotherapy, Concomitant Therapy and Maintenance Therapy in the Treatment of Acne Vulgaris.

November 1996 - August 1997

A Phase III Study of the Safety and Efficacy of an Injectable Medicated Solution in Subjects with Moderate to Severe Atopic Dermatitis.

November 1995 - December 1997

A Phase III Study of Five-Year Observational Study to Evaluate Clinical Response and Recurrence Rate on the Treatment of Basal Cell Carcinoma with a Medicated Injectable Gel.

Completed - March 1996

A Phase II Randomized Controlled Study to Evaluate the Contributions of Components in an Injectable Gel in Patients with Basal Cell Carcinoma.

1995

p16 Gene Mutation Sampling of Buccal Cells from Patients with a Previous History of Superficial Spreading Malignant Melanoma.

1994

Phase III Study of an Open-label Oral Medication Therapy for Severe Recalcitrant Plaque Psoriasis.

Completed - March 1994

A Phase III Open-label Study on a Topical Therapy for Superficial Basal Cell Carcinoma, Including a Double Blind Challenge Trial Evaluating a Medicated Gel in the Induction of Contact Sensitization with Repeated Topical Application.

Completed - December 1993

An Oral Retinoid Therapy Study for Basal Cell Carcinoma.