Stretch Marks on Abdomen

NCT03750422 | Unknown FDA Device

• 1 other identifier: STRATPHARMA-2018-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Striae; Albicantes

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Safety - Post Laser Treatment Adverse Events

  days 2, 5, 7, and 10 after each laser session

Study Arms (2)

Stratacel

ACTIVE COMPARATOR

medical grade silicone gel following Picoway Laser treatment

Device: Picoway; Other: Stratacel

Vehicle

SHAM COMPARATOR

Clear ultrasound gel following Picoway Laser treatment

Device: Picoway; Other: Aquasonic

Interventions

Picoway DEVICE

1064/532nm picosecond laser

Stratacel; Vehicle

Stratacel OTHER

a self-drying, bacteriostatic, transparent silicone gel with anti-inflammatory properties

Stratacel

Aquasonic OTHER

clear ultrasound gel

Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Goldman, Butterwick, Fitzpatrick and Groff: lead

Study Sites (1)

West Dermatology Research Center

San Diego, California, 92121, United States

Location

MeSH Terms

Conditions

Striae Distensae

Interventions

Aquasonic

Condition Hierarchy (Ancestors)

Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mitchel P Goldman, MD

  Cosmetic Laser Dermatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: CCRC

Model Details: double-blinded, randomized split-body study

Study Record Dates

• First Submitted: November 8, 2018
• First Posted: November 23, 2018
• Study Start: July 1, 2018
• Primary Completion: November 30, 2019
• Study Completion: December 31, 2019
• Last Updated: May 10, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)