Stretch Marks on Abdomen

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.

Study Overview

• Status: Unknown
• Conditions: Striae; Albicantes
• Intervention / Treatment: Device: Picoway; Other: Stratacel; Other: Aquasonic

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92121
      • West Dermatology Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Stratacel; medical grade silicone gel following Picoway Laser treatment	Device: Picoway; 1064/532nm picosecond laser; Other: Stratacel; a self-drying, bacteriostatic, transparent silicone gel with anti-inflammatory properties
SHAM_COMPARATOR: Vehicle; Clear ultrasound gel following Picoway Laser treatment	Device: Picoway; 1064/532nm picosecond laser; Other: Aquasonic; clear ultrasound gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Striae Texture	Assessment of texture Pre treatment and post final treatment using a 5-Point Blinded Investigator Striae Assessment scale	Pre-Treatment to 3-months post final treatment.
Change in Striae Color	Assessment of Color Pre treatment and post final treatment	Pre-Treatment to 3-months post final treatment.
Change in Striae Size	Assessment of Size Pre treatment and post final treatment using a 5-Point Blinded Investigator Striae Assessment scale.	Pre-Treatment to 3-months post final treatment.
Change in Striae Overall Appearance	Assessment of Overall Appearance Pre treatment and post final treatment using a 6-Point Blinded Investigator Striae Assessment scale	Pre-Treatment to 3-months post final treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety - Post Laser Treatment Adverse Events	erythema, edema, crusting, bruising, hyperpigmentation, hypopigmentation, and scarring	days 2, 5, 7, and 10 after each laser session

Collaborators and Investigators

• Sponsor: Goldman, Butterwick, Fitzpatrick and Groff

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2018
• Primary Completion (ANTICIPATED): November 30, 2019
• Study Completion (ANTICIPATED): December 31, 2019

Study Registration Dates

• First Submitted: November 8, 2018
• First Submitted That Met QC Criteria: November 20, 2018
• First Posted (ACTUAL): November 23, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 10, 2019
• Last Update Submitted That Met QC Criteria: May 8, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: STRATPHARMA-2018-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes