Acne ScarringNCT00510055
Treatment of Acne Scarring With a Novel Procedure Combination
A study testing subdermal manipulation ONLY and subdermal manipulation AND injection of a filler in people with Acne Scarring, run by Northwestern University at 1 site in United States.
Trial summary
The primary objective of this study is to look at the efficacy of subdermal manipulation and filler injection in the improvement of acne scar appearance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acne Scarring
- What is being tested?
- subdermal manipulation ONLY and subdermal manipulation AND injection of a filler
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Jul 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
- Age 18 and over
- Have two acne scar areas
- The subjects are in good health
- The subject has the willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator.
Who cannot join
- Under 18 years of age
- Pregnancy or Lactation
- Subjects who are unable to understand the protocol or to give informed consent
- Subjects with mental illness
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Feinberg School of Medicine, Department of Dermatology
Chicago, Illinois, 60611
About this study
Official title: The Effect of Subcision and Calcium Hydroxylapatite (Radiesse) Injection on Rolling Acne Scarring Appearance
The primary objective of this study is to look at the efficacy of subdermal manipulation and filler injection in the improvement of acne scar appearance.
Read the detailed description
The primary objective of this study is to determine whether the use of subcision in conjunction with calcium hydroxylapatite injections will improve the appearance of rolling acne scars better than subcision alone.
- Conditions
- Acne Scarring
- Being tested
- subdermal manipulation ONLY, subdermal manipulation AND injection of a filler
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
subdermal manipulation ONLYProcedure or surgery
Also called subcision
scars receive subdermal manipulation ONLY
subdermal manipulation AND injection of a fillerProcedure or surgery
Also called Radiesse
scars receive subdermal manipulation AND injection of a filler
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | scars receive subdermal manipulation ONLY Receives: Procedure: subdermal manipulation ONLY |
| B | Experimental | scars receive subdermal manipulation AND injection of a filler Receives: Procedure: subdermal manipulation AND injection of a filler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scar Improvement
Measured: 3.5 months
Secondary outcomes (1)
Adverse Events
Measured: 3.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2007 (estimated)
- Study startJun 2007
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne ScarringStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murad Alam, Northwestern University
- Investigators
- Murad Alam, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00510055
- Sponsor's protocol ID
- STU752
- Status last verified
- Nov 2021
- First submitted
- 31 Jul 2007
- Last updated
- 2 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Subcision and Calcium Hydroxylapatite (Radiesse) Injection on Rolling Acne Scarring Appearance
- ClinicalTrials.gov ID
- NCT00510055
- Acronym / sponsor ID
- STU752
- Conditions
- Acne Scarring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 1 Aug 2007 (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.
The primary objective of this study is to look at the efficacy of subdermal manipulation and filler injection in the improvement of acne scar appearance.
Detailed description
The primary objective of this study is to determine whether the use of subcision in conjunction with calcium hydroxylapatite injections will improve the appearance of rolling acne scars better than subcision alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Procedure: subdermal manipulation ONLYscars receive subdermal manipulation ONLY |
| B | Experimental | Procedure: subdermal manipulation AND injection of a fillerscars receive subdermal manipulation AND injection of a filler |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 and over
- Have two acne scar areas
- The subjects are in good health
- The subject has the willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator.
Key exclusion criteria (4 listed)
- Under 18 years of age
- Pregnancy or Lactation
- Subjects who are unable to understand the protocol or to give informed consent
- Subjects with mental illness
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 |
|---|---|---|
| subdermal manipulation ONLYAlso: subcisionscars receive subdermal manipulation ONLY | Procedure or surgery | A |
| subdermal manipulation AND injection of a fillerAlso: Radiessescars receive subdermal manipulation AND injection of a filler | Procedure or surgery | B |
Primary outcome
Scar Improvement
Time frame: 3.5 months
1 secondary outcome
Adverse Events
Time frame: 3.5 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 2 Dec 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.
Murad Alam, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing subdermal manipulation ONLY and subdermal manipulation AND injection of a filler in people with Acne Scarring, run by Northwestern University 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 4 inclusion and 4 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 2 Dec 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.
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?
Scar Improvement (time frame: 3.5 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 2 Dec 2021.