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Stretch Marks on Abdomen

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ClinicalTrials.gov Identifier: NCT03750422
Recruitment Status : Unknown
Verified May 2019 by Isabella Guiha, Goldman, Butterwick, Fitzpatrick and Groff.
Recruitment status was:  Active, not recruiting
First Posted : November 23, 2018
Last Update Posted : May 10, 2019
Sponsor:
Information provided by (Responsible Party):
Isabella Guiha, Goldman, Butterwick, Fitzpatrick and Groff

Brief 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.

Condition or disease Intervention/treatment Phase
Striae; Albicantes Device: Picoway Other: Stratacel Other: Aquasonic Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: double-blinded, randomized split-body study
Masking: Double (Participant, Investigator)
Masking Description: Subjects are provided with de-identified tubes of both study product and vehicle then instructed on which de-identified product is to be used for aftercare on which side of the abdomen.
Primary Purpose: Treatment
Official Title: A Split-body, Double-blinded, Placebo-controlled Trial of Stratacel® Wound Dressing After Laser Treatment of Striae Alba
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : December 31, 2019

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




Primary Outcome Measures :
  1. Change in Striae Texture [ Time Frame: Pre-Treatment to 3-months post final treatment. ]
    Assessment of texture Pre treatment and post final treatment using a 5-Point Blinded Investigator Striae Assessment scale

  2. Change in Striae Color [ Time Frame: Pre-Treatment to 3-months post final treatment. ]
    Assessment of Color Pre treatment and post final treatment

  3. Change in Striae Size [ Time Frame: Pre-Treatment to 3-months post final treatment. ]
    Assessment of Size Pre treatment and post final treatment using a 5-Point Blinded Investigator Striae Assessment scale.

  4. Change in Striae Overall Appearance [ Time Frame: Pre-Treatment to 3-months post final treatment. ]
    Assessment of Overall Appearance Pre treatment and post final treatment using a 6-Point Blinded Investigator Striae Assessment scale


Secondary Outcome Measures :
  1. Safety - Post Laser Treatment Adverse Events [ Time Frame: days 2, 5, 7, and 10 after each laser session ]
    erythema, edema, crusting, bruising, hyperpigmentation, hypopigmentation, and scarring



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03750422


Locations
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United States, California
West Dermatology Research Center
San Diego, California, United States, 92121
Sponsors and Collaborators
Goldman, Butterwick, Fitzpatrick and Groff
Investigators
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Principal Investigator: Mitchel P Goldman, MD Cosmetic Laser Dermatology
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Responsible Party: Isabella Guiha, CCRC, Goldman, Butterwick, Fitzpatrick and Groff
ClinicalTrials.gov Identifier: NCT03750422    
Other Study ID Numbers: STRATPHARMA-2018-01
First Posted: November 23, 2018    Key Record Dates
Last Update Posted: May 10, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes