Acne ScarsPhase 1NCT01704209
Collagen Injections for the Treatment of Acne Scars and Wrinkles
A Phase 1 study testing Fibroblast Treatment in people with Acne Scars and Wrinkles, run by Northwestern University at 1 site in United States.
Trial summary
The purpose of this study is to find out if autologous (your own) fibroblast injections are effective for the treatment of acne scars and wrinkles. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acne Scars, Wrinkles
- What is being tested?
- Fibroblast Treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Jun 2013
- Phase
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 or over
- Bilateral acne scars or have moderate to severe wrinkles
- Subjects in good health
- Subjects 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
- recent Accutane use in the past 6 months
- prone to hypertrophic and keloidal scarring
- have excessively redundant skin in the treatment area or wrinkles longer than 20 cm total
- have a history of autoimmune disorders, organ transplantation, cancer not in remission, active or chronic skin disease
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- have a history of basal-cell carcinoma
- have previously received autologous fibroblast treatment
- have undergone any confounding therapy in the lower two-thirds of the face within 1 year or any investigational treatment within 30 days.
- have an allergy to collagen, bovine products, local anesthetics, gentamicin, or amphotericin B
- 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: Pilot Study of Autologous Fibroblast Injection for Acne Scars, Forehead Lines, Lip Lines, Horizontal Neck Lines, and Static Crow's Feet
The purpose of this study is to find out if autologous (your own) fibroblast injections are effective for the treatment of acne scars and wrinkles.
- Conditions
- Acne Scars, Wrinkles
- Being tested
- Fibroblast Treatment, Vehicle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibroblast TreatmentDrug
VehicleProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Fibroblast Treatment | Experimental | The fibroblast treatment will be randomly injected into one side of the face. Receives: Drug: Fibroblast Treatment |
| Vehicle | Placebo comparator | The vehicle will be injected randomly to the other side of the face. Receives: Procedure: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of rater's comparisons at 6 months
Measured: Basline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2012 (estimated)
- Study startApr 2013
- Primary completionJun 2013
- Study completionJun 2013
Why it stopped: Company stopped making product for cosmetic use. All consented subjects withdrew before any study interventions were performed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne ScarsStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 4 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
- NCT01704209
- Sponsor's protocol ID
- STU67333
- Status last verified
- Dec 2021
- First submitted
- 27 Sep 2012
- Last updated
- 6 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Autologous Fibroblast Injection for Acne Scars, Forehead Lines, Lip Lines, Horizontal Neck Lines, and Static Crow's Feet
- ClinicalTrials.gov ID
- NCT01704209
- Acronym / sponsor ID
- STU67333
- Conditions
- Acne Scars, Wrinkles
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Company stopped making product for cosmetic use. All consented subjects withdrew before any study interventions were performed.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 11 Oct 2012 (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 purpose of this study is to find out if autologous (your own) fibroblast injections are effective for the treatment of acne scars and wrinkles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fibroblast Treatment | Experimental | Drug: Fibroblast TreatmentThe fibroblast treatment will be randomly injected into one side of the face. |
| Vehicle | Placebo comparator | Procedure: VehicleThe vehicle will be injected randomly to the other side of the face. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 or over
- Bilateral acne scars or have moderate to severe wrinkles
- Subjects in good health
- Subjects 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 (12 listed)
- Under 18 years of age
- Pregnancy or lactation
- recent Accutane use in the past 6 months
- prone to hypertrophic and keloidal scarring
- have excessively redundant skin in the treatment area or wrinkles longer than 20 cm total
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 |
|---|---|---|
| Fibroblast Treatment | Drug | Fibroblast Treatment |
| Vehicle | Procedure or surgery | Vehicle |
Primary outcome
Change from baseline of rater's comparisons at 6 months
Time frame: Basline and 6 months
Results and safety
The study was stopped early (reason given: Company stopped making product for cosmetic use. All consented subjects withdrew before any study interventions were performed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 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 Phase 1 study testing Fibroblast Treatment in people with Acne Scars and Wrinkles, 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 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: stopped early, as of the sponsor's last update on 6 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. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was stopped early (reason given: Company stopped making product for cosmetic use. All consented subjects withdrew before any study interventions were performed.). 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 from baseline of rater's comparisons at 6 months (time frame: Basline and 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 6 Dec 2021.