Striae; AlbicantesNCT03750422
Stretch Marks on Abdomen
A study testing Picoway, Stratacel and Aquasonic in people with Striae; Albicantes, run by Goldman, Butterwick, Fitzpatrick and Groff at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Striae; Albicantes
- What is being tested?
- Picoway, Stratacel and Aquasonic
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2018to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
- 1. Having no uterus 2. No menses for at least 12 months.
- Or:
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- 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).
Who cannot join
- 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.
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
West Dermatology Research Center
San Diego, California, 92121
About this study
Official title: A Split-body, Double-blinded, Placebo-controlled Trial of Stratacel® Wound Dressing After Laser Treatment of Striae Alba
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.
Read the 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.
- Conditions
- Striae; Albicantes
- Being tested
- Picoway, Stratacel, Aquasonic
- Medical subject headings
- Striae Distensae
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PicowayDevice
1064/532nm picosecond laser
StratacelOther
a self-drying, bacteriostatic, transparent silicone gel with anti-inflammatory properties
AquasonicOther
clear ultrasound gel
| Study group | Role | What they receive |
|---|---|---|
| Stratacel | Active comparator | medical grade silicone gel following Picoway Laser treatment Receives: Device: Picoway; Other: Stratacel |
| Vehicle | Sham comparator | Clear ultrasound gel following Picoway Laser treatment Receives: Device: Picoway; Other: Aquasonic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Striae Texture
Assessment of texture Pre treatment and post final treatment using a 5-Point Blinded Investigator Striae Assessment scale
Measured: Pre-Treatment to 3-months post final treatment.
Change in Striae Color
Assessment of Color Pre treatment and post final treatment
Measured: 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.
Measured: 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
Measured: Pre-Treatment to 3-months post final treatment.
Secondary outcomes (1)
Safety - Post Laser Treatment Adverse Events
erythema, edema, crusting, bruising, hyperpigmentation, hypopigmentation, and scarring
Measured: days 2, 5, 7, and 10 after each laser session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study start1 Jul 2018
- Primary completion30 Nov 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Striae; AlbicantesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- double-blinded, randomized split-body study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Goldman, Butterwick, Fitzpatrick and Groff
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isabella Guiha, Goldman, Butterwick, Fitzpatrick and Groff
- Investigators
- Mitchel P Goldman, MD, Principal investigator, Cosmetic Laser Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03750422
- Sponsor's protocol ID
- STRATPHARMA-2018-01
- Status last verified
- May 2019
- First submitted
- 8 Nov 2018
- Last updated
- 10 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Split-body, Double-blinded, Placebo-controlled Trial of Stratacel® Wound Dressing After Laser Treatment of Striae Alba
- ClinicalTrials.gov ID
- NCT03750422
- Acronym / sponsor ID
- STRATPHARMA-2018-01
- Conditions
- Striae; Albicantes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Goldman, Butterwick, Fitzpatrick and GroffUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 30 Nov 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 23 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- double-blinded, randomized split-body study
| Arm | Type | Receives |
|---|---|---|
| Stratacel | Active comparator | Device: Picoway, Other: Stratacelmedical grade silicone gel following Picoway Laser treatment |
| Vehicle | Sham comparator | Device: Picoway, Other: AquasonicClear ultrasound gel following Picoway Laser treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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:
- 1. Having no uterus 2. No menses for at least 12 months.
Key exclusion criteria (13 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Picoway1064/532nm picosecond laser | Device | Stratacel, Vehicle |
| Stratacela self-drying, bacteriostatic, transparent silicone gel with anti-inflammatory properties | Other | Stratacel |
| Aquasonicclear ultrasound gel | Other | Vehicle |
Primary outcome
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
Change in Striae Color
Time frame: Pre-Treatment to 3-months post final treatment.
Assessment of Color Pre treatment and post final treatment
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.
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
1 secondary outcome
Safety - Post Laser Treatment Adverse Events
Time frame: days 2, 5, 7, and 10 after each laser session
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2019.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mitchel P Goldman, MD principal investigator
Cosmetic Laser Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Picoway, Stratacel and Aquasonic in people with Striae; Albicantes, run by Goldman, Butterwick, Fitzpatrick and Groff at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Striae Texture (time frame: Pre-Treatment to 3-months post final treatment.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2019.