Striae; Albicantes Clinical Trial
Official title:
A Split-body, Double-blinded, Placebo-controlled Trial of Stratacel® Wound Dressing After Laser Treatment of Striae Alba
Verified date | May 2019 |
Source | Goldman, Butterwick, Fitzpatrick and Groff |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | West Dermatology Research Center | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
Goldman, Butterwick, Fitzpatrick and Groff |
United States,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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LLLT and Fractional CO2 Laser in the Treatment of Stria Alba
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Efficacy of Short Pulsed 1064 nm Nd-YAG Laser Versus 10600 nm Fractional CO2 Laser in Treatment of Striae Alba
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