DécolletageNCT03508973
Sculptra for Décolletage Crepiness and Wrinkling
A study testing Sculpta in people with Décolletage, run by Skin Laser & Surgery Specialists.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of Sculptra as a volume agent to improve décolletage crepiness and wrinkling. Read more about this study
- Who is it for?
- Ages 40 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Décolletage
- What is being tested?
- Sculpta
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 9 Nov 2015to 13 Dec 2016
- 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 40 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female volunteer
- Aged from 40-70 years on the day of screening
- No known medical conditions that may interfere with study participation
- Moderate to severe crepiness and wrinkling of the décolletage
- Willingness to not use any products on their décolleté for the duration of the study
- Read, understand, and sign informed consent forms
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- Willingness to sign photography release form
- Willing and able to comply with all follow-up requirements
- Willingness to undergo a series of three Sculptra injections, 2-3 months apart, in their décolletage
Who cannot join
- Any significant skin disease at treatment area
- Any medical condition which could interfere with the treatment
- Inability or unwillingness to follow the treatment schedule
- Inability or unwillingness to sign the informed consent
- History of poor wound healing
- History of keloid formation
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- History of HIV, hepatitis, immuno-compromised
- Pregnant or lactating
- Previous use of deep chemical peels on the treatment area
- Previous injections of Sculptra in the décolletage
- Known hypersensitivity to Sculptra or any of its ingredients
- Previous laser or light based treatments to the treatment area 6 months prior to the screening visit
About this study
The purpose of this study is to evaluate the safety and efficacy of Sculptra as a volume agent to improve décolletage crepiness and wrinkling.
- Conditions
- Décolletage
- Being tested
- Sculpta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SculptaOther
| Study group | Role | What they receive |
|---|---|---|
| Sculptra | Experimental | Sculptra, an injectable implant containing microparticles of ply-L-lactic acid, carboxymethylcellulose, non-pyrogenic mannitol and sterile water, will be injected into the decolletage. Receives: Other: Sculpta |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in décolletage crepiness and wrinkling in treatment area as measured by 5 point décolletage wrinkle scale
Measured: Screening, Treatment 1, Treatment 2, Treatment 3, 1 Month Follow up, 3 Month Follow up and 6 Month Follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2018
- Study start9 Nov 2015
- Primary completion13 Dec 2016
- Study completion13 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DécolletageStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Skin Laser & Surgery Specialists
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David J. Goldberg, MD, Skin Laser & Surgery Specialists
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03508973
- Sponsor's protocol ID
- SCULPTDEC01
- Status last verified
- Apr 2018
- First submitted
- 26 May 2016
- Last updated
- 26 Apr 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sculptra for Décolletage Crepiness and Wrinkling
- ClinicalTrials.gov ID
- NCT03508973
- Acronym / sponsor ID
- SCULPTDEC01
- Conditions
- Décolletage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Skin Laser & Surgery SpecialistsUniversity, hospital or other
- Study start
- 9 Nov 2015 (actual)
- Primary completion
- 13 Dec 2016 (actual)
- Study completion
- 13 Dec 2016 (actual)
- First posted
- 26 Apr 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 purpose of this study is to evaluate the safety and efficacy of Sculptra as a volume agent to improve décolletage crepiness and wrinkling.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sculptra | Experimental | Other: SculptaSculptra, an injectable implant containing microparticles of ply-L-lactic acid, carboxymethylcellulose, non-pyrogenic mannitol and sterile water, will be injected into the decolletage. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Female volunteer
- Aged from 40-70 years on the day of screening
- No known medical conditions that may interfere with study participation
- Moderate to severe crepiness and wrinkling of the décolletage
- Willingness to not use any products on their décolleté for the duration of the study
Key exclusion criteria (12 listed)
- Any significant skin disease at treatment area
- Any medical condition which could interfere with the treatment
- Inability or unwillingness to follow the treatment schedule
- Inability or unwillingness to sign the informed consent
- History of poor wound healing
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 |
|---|---|---|
| Sculpta | Other | Sculptra |
Primary outcome
Change in décolletage crepiness and wrinkling in treatment area as measured by 5 point décolletage wrinkle scale
Time frame: Screening, Treatment 1, Treatment 2, Treatment 3, 1 Month Follow up, 3 Month Follow up and 6 Month Follow up
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 Apr 2018.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Sculpta in people with Décolletage, run by Skin Laser & Surgery Specialists.
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 9 inclusion and 12 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 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
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 décolletage crepiness and wrinkling in treatment area as measured by 5 point décolletage wrinkle scale (time frame: Screening, Treatment 1, Treatment 2, Treatment 3, 1 Month Follow up, 3 Month Follow up and 6 Month Follow up). 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 Apr 2018.