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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03750422
Other study ID # STRATPHARMA-2018-01
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date July 1, 2018
Est. completion date December 31, 2019

Study information

Verified date May 2019
Source Goldman, Butterwick, Fitzpatrick and Groff
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 20
Est. completion date December 31, 2019
Est. primary completion date November 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
Picoway
1064/532nm picosecond laser
Other:
Stratacel
a self-drying, bacteriostatic, transparent silicone gel with anti-inflammatory properties
Aquasonic
clear ultrasound gel

Locations

Country Name City State
United States West Dermatology Research Center San Diego California

Sponsors (1)

Lead Sponsor Collaborator
Goldman, Butterwick, Fitzpatrick and Groff

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Primary Change in Striae Color Assessment of Color Pre treatment and post final treatment Pre-Treatment to 3-months post final treatment.
Primary 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.
Primary 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 Safety - Post Laser Treatment Adverse Events erythema, edema, crusting, bruising, hyperpigmentation, hypopigmentation, and scarring days 2, 5, 7, and 10 after each laser session
See also
  Status Clinical Trial Phase
Completed NCT04165226 - LLLT and Fractional CO2 Laser in the Treatment of Stria Alba N/A
Recruiting NCT04092881 - Efficacy of Short Pulsed 1064 nm Nd-YAG Laser Versus 10600 nm Fractional CO2 Laser in Treatment of Striae Alba N/A