Striae DistensaeEarly Phase 1FADeSNCT03858543
Fractional Laser Assisted Delivery of Sculptra® for the Treatment of Striae
A Early Phase 1 study testing Poly-L Lactic Acid and Fractional laser treatment in people with Striae Distensae, run by Henry Ford Health System at 1 site in United States.
Trial summary
This study evaluates the efficacy of treatment of striae distensae using the combined modality of fractional laser and poly-L lactic acid (Sculptra). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Striae Distensae
- What is being tested?
- Poly-L Lactic Acid and Fractional laser treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2019to 31 Jan 2021
- Phase
- Early Phase 1
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has bilateral striae alba
- Subject has stable body weight for at least 6 months with Fitzpatrick skin type 1-4
Who cannot join
- Subject has striae rubra
- Pregnant
- History of adverse effects to phototherapy
- Subject has single sided lesions
- Subject has immunosuppression
- Subject has radiation therapy to the study area
- Subject has topical or oral steroid use or chemotherapy within the last 6 months
- History of keloids or hypertrophic scar
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fractional Laser Assisted Delivery of Sculptra® for the Treatment of Striae: FADeS Trial
This study evaluates the efficacy of treatment of striae distensae using the combined modality of fractional laser and poly-L lactic acid (Sculptra).
Read the detailed description
Striae Distensae (SD) is a form of scarring that can oftentimes be quite disfiguring and emotionally distressing to individuals.
Fractional laser therapy has been used by doctors to treat stretch marks by stimulating collagen growth.
Poly-L lactic acid also promotes collagen growth in the areas injected.
The combination of laser and poly-L lactic acid might provide the optimal treatment modality for SD by decreasing the appearance of atrophic scars.
- Conditions
- Striae Distensae
- Being tested
- Poly-L Lactic Acid, Fractional laser treatment
- Keywords
- Stretch marks, Fractional laser therapy, Poly-L lactic acid, Sculptra
- Medical subject headings
- Striae Distensae
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Poly-L Lactic AcidDrug
Also called Sculptra
After initial treatment, reassessment will be conducted at 3 follow-up visits. Photographs will be taken for blinded evaluators to compare post-treatment to the original pre-treatment photographs. At final visit, a questionnaire will be administered to rate treatment satisfaction.
Fractional laser treatmentDevice
Also called Sciton Laser
After initial treatment, reassessment will be conducted at 3 follow-up visits. Photographs will be taken for blinded evaluators to compare post-treatment to the original pre-treatment photographs. At final visit, a questionnaire will be administered to rate treatment satisfaction.
| Study group | Role | What they receive |
|---|---|---|
| Fractional laser treatment & Poly-L Lactic Acid (Sculptra) | Experimental | One Fractional laser treatment on half of the body with Sciton Laser and Scluptra Receives: Drug: Poly-L Lactic Acid; Device: Fractional laser treatment |
| Fractional laser treatment | Active comparator | One Fractional laser treatment on half of the body with Sciton Laser Receives: Device: Fractional laser treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Stretch Mark Size
Modified Manchester Scar Scale was used to assess stretch mark reduction compared to pre-treatment photographs. The range of each subscale is between 4-26. A higher value represents a worse outcome. A value of 26 is the maximum score and represents the worst outcome. A value of 4 is the minimum score and represents the best outcome. Subscales are then summed to compute a total score.
Measured: Baseline (Pre-treatment) vs. 3 Months, 4 Months, 5 Months, 6 Months
Secondary outcomes (4)
Treatments Superiority Assessment
Modified Manchester Scar Scale was used to assess and judge whether erbium-YAG fractionated laser therapy plus Sculptra is superior to laser therapy alone. The range of each subscale is between 4-26. A higher value represents a worse outcome. A value of 26 is the maximum score and represents the worst outcome. A value of 4 is the minimum score and represents the best outcome. Subscales are then summed to compute a total score.
Measured: 3 Months
Treatments Superiority Assessment
Modified Manchester Scar Scale was used to assess and judge whether erbium-YAG fractionated laser therapy plus Sculptra is superior to laser therapy alone. The range of each subscale is between 4-26. A higher value represents a worse outcome. A value of 26 is the maximum score and represents the worst outcome. A value of 4 is the minimum score and represents the best outcome. Subscales are then summed to compute a total score.
Measured: 4 Months
Treatments Superiority Assessment
Modified Manchester Scar Scale was used to assess and judge whether erbium-YAG fractionated laser therapy plus Sculptra is superior to laser therapy alone. The range of each subscale is between 4-26. A higher value represents a worse outcome. A value of 26 is the maximum score and represents the worst outcome. A value of 4 is the minimum score and represents the best outcome. Subscales are then summed to compute a total score.
Measured: 5 Months
Treatments Superiority Assessment
Modified Manchester Scar Scale was used to assess and judge whether erbium-YAG fractionated laser therapy plus Sculptra is superior to laser therapy alone. The range of each subscale is between 4-26. A higher value represents a worse outcome. A value of 26 is the maximum score and represents the worst outcome. A value of 4 is the minimum score and represents the best outcome. Subscales are then summed to compute a total score.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2019
- Study start15 Jul 2019
- Primary completion31 Jan 2021
- Study completion31 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Striae DistensaeStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Galderma R&D
- Responsible party
- Principal investigator, aamir siddiqui, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03858543
- Sponsor's protocol ID
- 11951
- Acronym
- FADeS
- Status last verified
- Aug 2021
- First submitted
- 18 Feb 2019
- Last updated
- 26 Aug 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fractional Laser Assisted Delivery of Sculptra® for the Treatment of Striae: FADeS Trial
- ClinicalTrials.gov ID
- NCT03858543
- Acronym / sponsor ID
- FADeS / 11951
- Conditions
- Striae Distensae
- Keywords
- Stretch marks, Fractional laser therapy, Poly-L lactic acid, Sculptra
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Collaborators
- Galderma R&D
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 28 Feb 2019 (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.
This study evaluates the efficacy of treatment of striae distensae using the combined modality of fractional laser and poly-L lactic acid (Sculptra).
Detailed description
Striae Distensae (SD) is a form of scarring that can oftentimes be quite disfiguring and emotionally distressing to individuals.
Fractional laser therapy has been used by doctors to treat stretch marks by stimulating collagen growth.
Poly-L lactic acid also promotes collagen growth in the areas injected.
The combination of laser and poly-L lactic acid might provide the optimal treatment modality for SD by decreasing the appearance of atrophic scars.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fractional laser treatment & Poly-L Lactic Acid (Sculptra) | Experimental | Drug: Poly-L Lactic Acid, Device: Fractional laser treatmentOne Fractional laser treatment on half of the body with Sciton Laser and Scluptra |
| Fractional laser treatment | Active comparator | Device: Fractional laser treatmentOne Fractional laser treatment on half of the body with Sciton Laser |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject has bilateral striae alba
- Subject has stable body weight for at least 6 months with Fitzpatrick skin type 1-4
Key exclusion criteria (8 listed)
- Subject has striae rubra
- Pregnant
- History of adverse effects to phototherapy
- Subject has single sided lesions
- Subject has immunosuppression
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 |
|---|---|---|
| Poly-L Lactic AcidAlso: SculptraAfter initial treatment, reassessment will be conducted at 3 follow-up visits. Photographs will be taken for blinded evaluators to compare post-treatment to the original pre-treatment photographs. At final visit, a questionnaire will be administered to rate treatment satisfaction. | Drug | Fractional laser treatment & Poly-L Lactic Acid (Sculptra) |
| Fractional laser treatmentAlso: Sciton LaserAfter initial treatment, reassessment will be conducted at 3 follow-up visits. Photographs will be taken for blinded evaluators to compare post-treatment to the original pre-treatment photographs. At final visit, a questionnaire will be administered to rate treatment satisfaction. | Device | Fractional laser treatment, Fractional laser treatment & Poly-L Lactic Acid (Sculptra) |
Primary outcome
Change in Stretch Mark Size
Time frame: Baseline (Pre-treatment) vs. 3 Months, 4 Months, 5 Months, 6 Months
Modified Manchester Scar Scale was used to assess stretch mark reduction compared to pre-treatment photographs. The range of each subscale is between 4-26. A higher value represents a worse outcome. A value of 26 is the maximum score and represents the worst outcome. A value of 4 is the minimum score and represents the best outcome. Subscales are then summed to compute a total score.
4 secondary outcomes
Treatments Superiority Assessment
Time frame: 3 Months
Treatments Superiority Assessment
Time frame: 4 Months
Treatments Superiority Assessment
Time frame: 5 Months
Treatments Superiority Assessment
Time frame: 6 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Poly-L Lactic Acid and Fractional laser treatment in people with Striae Distensae, run by Henry Ford Health System 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 2 inclusion and 8 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: finished, as of the sponsor's last update on 26 Aug 2021. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Stretch Mark Size (time frame: Baseline (Pre-treatment) vs. 3 Months, 4 Months, 5 Months, 6 Months). 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 26 Aug 2021.