Acne VulgarisNCT00795327
Injectable POLY-L-Lactic Acid for Treatment of Hill and Valley Acne Scarring
A study testing Sculptra (Poly-L-Lactic Acid Dermal Implant) in people with Acne Vulgaris, run by Bausch Health Americas, Inc. at 1 site in Canada.
Trial summary
Primary: Evaluate the degree of correction attainable with Poly-L-Lactic Acid(Sculptra) for the correction of hill and valley acne scarring Secondary: Document types and incidence of device adverse events with Poly-L-Lactic Acid(Sculptra) therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Sculptra (Poly-L-Lactic Acid Dermal Implant)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2008to Sep 2009
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatient seeking therapy for correction of hill and valley acne scarring.
- Ability and willingness to understand and comply with requirements of the trial
Who cannot join
- The subject has active acne or chronic skin disease, inflammation or related conditions, such as infection, psoriasis and herpes zoster
- History of presence of keloid formation or hypertrophic scars
- History of procedures that precipitate an active dermal inflammatory or hyperplastic response (i.e., epilation or radiofrequency laser and chemical peeling procedures) within one month of study entry
- History of use of facial tissue augmenting therapy or aesthetic facial surgical therapy within six months prior to study entry
- Concomitant anticoagulant therapy, antiplatelet therapy or has any bleeding disorders
- History of unanticipated adverse reactions when treated with hyaluronic acid based products
Show all 16Show fewer
- Any condition which in the opinion of the investigator makes the patient unable to complete the study per protocol (e.g., patients not likely to avoid other facial cosmetic treatments; patients not likely to stay in the study for its duration because of other commitments, concomitant conditions, or past history; patients anticipated to be unreliable, or patients who have a concomitant condition that may develop symptoms that might confuse or confound study treatments or assessments)
- History of or current cancerous or pre-cancerous lesions in the area to be treated
- Use of any investigational drugs or any other medical devices within 30 days of enrolment
- Use of any prohibited medication within a proscribed time period before entry
- Pregnancy
- Recent use of Accutane (patient should not be on Accutane for the last 6 months)
- History of allergic/anaphylactic reactions, including hypersensitivity to local anaesthetics (lidocaine)
- Recent history of trauma in the face (less that 1 year)
- Previous of Dermalive or Dermadeep
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Canadian Study of the Use of Injectable Poly-L-Lactic Acid Dermal Implant for the Treatment of Hill and Valley Acne Scarring
Primary:
Evaluate the degree of correction attainable with Poly-L-Lactic Acid(Sculptra) for the correction of hill and valley acne scarring
Secondary:
Document types and incidence of device adverse events with Poly-L-Lactic Acid(Sculptra) therapy.
- Conditions
- Acne Vulgaris
- Being tested
- Sculptra (Poly-L-Lactic Acid Dermal Implant)
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sculptra (Poly-L-Lactic Acid Dermal Implant)Device
Drug Device study
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | single arm study Receives: Device: Sculptra (Poly-L-Lactic Acid Dermal Implant) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physician Scar Improvement Scale (PSIS)
Measured: At each visit
Self-Assessed Scar Improvement Scale (SASIS).
Measured: At each visit
Secondary outcomes (2)
Degree of subject satisfaction with treatment
Measured: At each Visit
Adverse events
Measured: At each visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2008 (estimated)
- Study startOct 2008
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- More trials run by Bausch Health Americas, Inc.The 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch Health Americas, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mary Tzortzis, Study chair, Sanofi-Aventis Canada Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00795327
- Sponsor's protocol ID
- POLYL_L_02508
- Status last verified
- Nov 2019
- First submitted
- 20 Nov 2008
- Last updated
- 20 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Canadian Study of the Use of Injectable Poly-L-Lactic Acid Dermal Implant for the Treatment of Hill and Valley Acne Scarring
- ClinicalTrials.gov ID
- NCT00795327
- Acronym / sponsor ID
- POLYL_L_02508
- Conditions
- Acne Vulgaris
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 21 Nov 2008 (estimated)
- 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.
Primary:
Evaluate the degree of correction attainable with Poly-L-Lactic Acid(Sculptra) for the correction of hill and valley acne scarring
Secondary:
Document types and incidence of device adverse events with Poly-L-Lactic Acid(Sculptra) therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Sculptra (Poly-L-Lactic Acid Dermal Implant)single arm study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Outpatient seeking therapy for correction of hill and valley acne scarring.
- Ability and willingness to understand and comply with requirements of the trial
Key exclusion criteria (16 listed)
- The subject has active acne or chronic skin disease, inflammation or related conditions, such as infection, psoriasis and herpes zoster
- History of presence of keloid formation or hypertrophic scars
- History of procedures that precipitate an active dermal inflammatory or hyperplastic response (i.e., epilation or radiofrequency laser and chemical peeling procedures) within one month of study entry
- History of use of facial tissue augmenting therapy or aesthetic facial surgical therapy within six months prior to study entry
- Concomitant anticoagulant therapy, antiplatelet therapy or has any bleeding disorders
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 |
|---|---|---|
| Sculptra (Poly-L-Lactic Acid Dermal Implant)Drug Device study | Device | 1 |
Primary outcome
Physician Scar Improvement Scale (PSIS)
Time frame: At each visit
Self-Assessed Scar Improvement Scale (SASIS).
Time frame: At each visit
2 secondary outcomes
Degree of subject satisfaction with treatment
Time frame: At each Visit
Adverse events
Time frame: At each visit
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 20 Nov 2019.
Related trials for Acne Vulgaris
Not yet recruitingPhase 3
Evaluation of the Efficacy and Safety of Fractional CO₂ Laser With and Without Intradermal Botulinum Toxin A in the Treatment of Inflammatory Facial Acne Vulgaris.
Acne, Acne Papulopustulosa
RecruitingPhase 4
Safety, Tolerability, and Clinical Effectiveness of Adapalene/Clindamycin Phosphate Gel (Klenzit®-C) in Vietnamese Patients With Mild to Moderate Acne Vulgaris
Acne
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
Acne Vulgaris
RecruitingPhase 4
Comparing Nadifloxacin Plus Tretinoin Versus Clindamycin Plus Tretinoin Creams for Mild-to-Moderate Acne
Acne Vulgaris
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal
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.
Mary Tzortzis study chair
Sanofi-Aventis Canada Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sculptra (Poly-L-Lactic Acid Dermal Implant) in people with Acne Vulgaris, run by Bausch Health Americas, Inc. at 1 site in Canada.
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 16 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 20 Nov 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 Canada. 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.
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?
Physician Scar Improvement Scale (PSIS) (time frame: At each visit). The study lists 2 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 20 Nov 2019.