TR-987 vs. Placebo Following Fractionated CO2 Laser Resurfacing of the Chest

NCT ID: NCT02681224

Last Updated: 2017-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2017-01-31

Brief Summary

A single site, double-blind, randomized, placebo-controlled, clinical study comparing the difference between a novel healing gel and a placebo gel on post laser-resurfacing chests.

Detailed Description

This is a double-blind, randomized, placebo-controlled, chest clinical study with a single study site. Forty subjects will receive fractionated CO2 laser resurfacing of the chest. . Immediately following the procedure (Day 0), postoperative gel randomized to the chest (TR-987 or placebo), will be applied with a thickness of 1-2 mm by a non-blinded coordinator, along with a split-chest Silon TSR bandage. Subjects will return for follow up on Day 1, with the gel and split chest Silon TSR© bandages applied by non-blinded coordinator during visit, with further follow-up on Days 6, 8, 10, 13 and 28. Both subjects and evaluating investigator will be blinded to randomization schedule (performed by an unblinded coordinator). Subject will apply gels and split chest Silon TSR© bandages at home on Days 2, 3 and 4 when not visiting clinic.

Conditions

Exposure Laser

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Active Product with Occlusion

TR987 Gel with Silon Bandage

Group Type: ACTIVE_COMPARATOR

TR987 Gel with Silon Bandage

Intervention Type: OTHER

Novel healing gel with occlusive dressing

Active Product without Occlusion

TR987 without Silon Bandage

Group Type: ACTIVE_COMPARATOR

TR987 without Silon Bandage

Intervention Type: OTHER

Novel healing gel without occlusive dressing

Placebo Gel with Occlusion

Placebo Gel with Silon Bandage

Group Type: PLACEBO_COMPARATOR

Placebo Gel with Silon Bandage

Intervention Type: OTHER

Placebo gel with occlusive dressing

Placebo Gel without Occlusion

Placebo Gel without Silon Bandage

Group Type: PLACEBO_COMPARATOR

Placebo Gel without Silon Bandage

Intervention Type: OTHER

Placebo Gel without occlusive dressing

Interventions

TR987 Gel with Silon Bandage

Novel healing gel with occlusive dressing

Intervention Type: OTHER

TR987 without Silon Bandage

Novel healing gel without occlusive dressing

Intervention Type: OTHER

Placebo Gel with Silon Bandage

Placebo gel with occlusive dressing

Intervention Type: OTHER

Placebo Gel without Silon Bandage

Placebo Gel without occlusive dressing

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Females or males in good general health greater than 18 years of age.
• Must be willing to give and sign a HIPPA form, informed consent form, and a photographic release form
• Subject is planning to undergo fractionated CO2 laser resurfacing to the chest
• A potential subject's must exhibit:

--Skin phototype of Fitzpatrick Type I-IV

• For FEMALE SUBJECT OF CHILDBEARING POTENTIAL, must have had a regular menstrual cycle prior to study entry (a female is considered of childbearing potential unless she is postmenopausal, without a uterus and/or both ovaries, or has had a bilateral tubal ligation) and is willing to use an acceptable form of birth control during the entire course of the study [i.e., acceptable methods of birth control are oral contraceptives, contraceptive patches/rings/implants Norplant®, Depo-Provera®, double-barrier methods (e.g. condoms and spermicide), abstinence and vasectomies of partner with a documented second acceptable method of birth control should the subject become sexually active]. All systemic birth control measures must be in consistent use at least 30 days prior to study participation. Postmenopausal is defined as having the last menstrual cycle in at least 12 months
• Negative urine pregnancy test results at the time of study entry (if applicable)
• Must be willing to comply with study dosing and complete the entire course of the study.

Exclusion Criteria

• A subject with any UNCONTROLLED systemic disease at the discretion of the Investigator. A potential subject in whom therapy for a systemic disease is not yet stabilized will not be considered for entry into the study
• A subject with a significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would preclude enrollment into the study.
• A subject with recently excessive exposure to sunlight or artificial UV light (e.g.: use of tanning beds/booths and/or sunbathing) or expectations of tanning during the time of the study or has used self-tanner within 7 days of study entry.
• A subject with history of or the presence of any skin condition/disease that might interfere with the diagnosis or evaluation of study parameters (i.e., atopic dermatitis, eczema, psoriasis, seborrheic dermatitis) at the discretion of the investigator.
• A subject with an active bacterial, fungal, or viral infection in the treatment area.
• A subject with known allergies or sensitivities to benzocaine, lidocaine, tetracaine, PABA (para-aminobenzoic acid), or other local anesthetics of the amide or ester family sedation medication.
• A subject with known allergy or sensitivity to propylene glycol or any other ingredient of topical TR-987 or placebo.
• A subject receiving any topical products containing alpha-hydroxy acids, salicylic acid, and vitamins C or E (includes derivatives thereof) on the chest within 14 days prior to or during the study period, other than the study products
• A subject receiving any investigational drug and/or has had a microdermabrasion (light or medium skin peel) treatment on their chest within 30 days prior to or during the study period
• A subject using any topical tretinoin product or derivative on their chest within 12 weeks prior to or during the study period
• A subject receiving a chemical peel, any systemic steroids, a non-ablative laser, light or radio frequency treatment and/or has had a Dermabrasion (deep skin peel) or ablative laser treatments on their chest must have discontinued the drug/treatment and/or have completed the treatment or the procedure at least 3 months prior to entering the study.
• A subject with a history of keloids or hypertrophic scars
• A subject that has previously been treated with a systemic retinoid within the past year (e.g., Accutane®, Roche Dermatologics)
• A female subject who is pregnant, nursing an infant or planning a pregnancy during the study [throughout the course of the study, women of child-bearing potential must use reliable forms of contraception (i.e., oral contraceptive, contraceptive patches/rings/implants Norplant®, Depo-Provera®, double-barrier methods (e.g. condoms and spermicide), abstinence, or vasectomies of partner with a documented second acceptable method of birth control should the subject become sexually active].
• Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Goldman, Butterwick, Fitzpatrick and Groff

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mitchel P Goldman, MD

Role: PRINCIPAL_INVESTIGATOR

Cosmetic Laser Dermatology

Locations

Cosmetic Laser Dermatology

San Diego, California, United States

Countries

United States

Other Identifiers

TR987-2013-01

Identifier Type: -

Identifier Source: org_study_id