Stretch Marks on Abdomen



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:11/24/2018
Start Date:July 1, 2018
End Date:December 31, 2019
Contact:Daniel Leeper
Email:DLeeper@CLDerm.com
Phone:858 657 1004

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A Split-body, Double-blinded, Placebo-controlled Trial of Stratacel® Wound Dressing After Laser Treatment of Striae Alba

The primary objective of this study is to determine the effect of Stratacel® wound dressing
on cosmetic outcomes following 1064/532nm picosecond laser (Picoway®, Syneron Candela Corp,
Wayland, MA, USA) treatment of abdominal striae alba. Secondary objectives include examining
the effect of Stratacel® wound dressing on post-laser healing and symptomatology.

Twenty adult subjects with abdominal striae alba will be enrolled. All striae will be treated
using the 1064/532nm picosecond laser with designated and standardized settings (Appendix A).
The abdominal striae treatment region will then be split across the body vertically with one
half randomized to Stratacel® and the other to placebo, clear ultrasound gel (Aquasonic). A
blinded study coordinator will apply the products to each randomized half-abdomen immediately
following laser treatment.

A total of 3 treatments will be completed at 1 month intervals. Blinded-investigator and
subject self-assessments will be performed at post-treatment days 2, 5, 7, and 10 after each
laser session. Assessments will also be performed 1 and 3 months after the final laser
treatment.

Inclusion Criteria:

1. Females or Males in good general health >18 years of age.

2. Must be willing to give and sign a photography release, HIPPA and informed consent.

3. Subject must have at least 2 white striae on each treatment side of the abdomen that
measure at least 1cm in length.

4. Females will be either of non-childbearing potential defined as:

1. Having no uterus 2. No menses for at least 12 months.

Or:

Women of childbearing potential must agree to use an effective method of birth control
during the course of the study. All systemic birth control measures must be in consistent
use for at least 30 days prior to study enrollment participation. Expectable forms of birth
control below:

1. Oral contraceptive pill, injection, implant, patch, vaginal ring, intrauterine device

2. Intrauterine coil

3. Bilateral tubal ligation

4. Barrier method used with an additional form of contraception (e.g., sponge, spermicide
or condom)

5. Abstinence (If practicing abstinence must agree to use barrier method described above
(4) if becomes sexually active).

6. Vasectomized (must agree to use barrier method described above (4) if becomes sexually
active with un-vasectomized partner).

Exclusion Criteria:

1. Pregnancy, planned pregnancy during the course of the study or currently breast feeding.

2. Projected significant fluctuations in weight during the course of the study or within
the last 6 months, per investigator discretion.

1. Recent use of self-tanners, excessive exposure to sunlight, artificial UV light (e.g.:
use of tanning beds/booths and/or sunbathing) or expectations of tanning and/or use of
self-tanners during the course of the study.

2. Any planned surgical or cosmetic procedure in the treatment area during the course of
the study.

3. Any UNCONTROLLED systemic disease -a potential patient in whom therapy for a systemic
disease is not yet stabilized will not be considered for entry into the study.

4. Significant history or current evidence of a medical, psychological or other disorder
that, in the investigator's opinion, would preclude enrollment into the study.

5. Red or brown colored striae in the intended treatment area.

6. Active dermatitis, open wound, active bacterial, neurologic, fungal, or viral
infection in the proposed treatment area.

7. Inability to ambulate following the procedure.

8. History of skin tightening or other treatment in the striae region in the preceding 12
months before study enrollment and for duration of the study.

9. Use of topical retinoids, hydroquinone, medicated cleansers, cellulite creams, or
steroids to the treatment area within the preceding 2 weeks and for duration of the
study.

10. Allergy to any ingredient in the study medication or placebo.

11. 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
9339 Genesee Avenue
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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