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



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:September 2015
End Date:January 2017
Contact:Isabella C Guiha
Email:IGuiha@CLDerm.com
Phone:858 657 1004

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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.

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.

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.
We found this trial at
1
site
San Diego, California 92121
Principal Investigator: Mitchel P Goldman, MD
Phone: 858-657-1004
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mi
from
San Diego, CA
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