Stretch Marks on Abdomen

Status unconfirmed · Not applicable

Conditions studied: Striae; Albicantes

In brief

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.

Key facts

Study ID

NCT03750422

Run by

Goldman, Butterwick, Fitzpatrick and Groff

People needed

20

Starts

2018-07-01

Expected to finish

2019-12-31

Last updated by the study team

2019-05-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Females or Males in good general health >18 years of age.
• Must be willing to give and sign a photography release, HIPPA and informed consent.
• Subject must have at least 2 white striae on each treatment side of the abdomen that measure at least 1cm in length.
• Females will be either of non-childbearing potential defined as:
• 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:
• Oral contraceptive pill, injection, implant, patch, vaginal ring, intrauterine device
• Intrauterine coil
• Bilateral tubal ligation
• Barrier method used with an additional form of contraception (e.g., sponge, spermicide or condom)
• Abstinence (If practicing abstinence must agree to use barrier method described above (4) if becomes sexually active).
• Vasectomized (must agree to use barrier method described above (4) if becomes sexually active with un-vasectomized partner).

You may not qualify if…

• Pregnancy, planned pregnancy during the course of the study or currently breast feeding.
• Projected significant fluctuations in weight during the course of the study or within the last 6 months, per investigator discretion.
• 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.
• Any planned surgical or cosmetic procedure in the treatment area during the course of the study.
• 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.
• Significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would preclude enrollment into the study.
• Red or brown colored striae in the intended treatment area.
• Active dermatitis, open wound, active bacterial, neurologic, fungal, or viral infection in the proposed treatment area.
• Inability to ambulate following the procedure.
• 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.
• 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.
• Allergy to any ingredient in the study medication or placebo.
• Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study.

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.