Atrophic Acne ScarsNCT01773343
Treatment of Atrophic Acne Scars With a Fractional CO2 Laser at 1 Versus 3 Months Intervals
A study testing Laser in people with Atrophic Acne Scars, run by Aarhus University Hospital at 1 site in Denmark.
Trial summary
To compare efficacy and adverse effects of fractional CO2 laser of acne scars treatment with 1 versus 3 months intervals Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Atrophic Acne Scars
- What is being tested?
- Laser
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2011to Jan 2013
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Have Fitzpatrick skin type I-III. (•Are male or female.
- Are between 18 and 60 years of age.
- Mild to severe acne scarring.
- Are able to read, understand, and sign the Informed Consent.
- Are willing and able to comply with all follow-up requirements -
Who cannot join
- Have had active localized or systemic infections within 6 months of enrollment
- Have compromised ability for wound healing, such as: malnutrition, oral steroid use, history of collagen vascular disease (e.g. lupus, scleroderma, history of keloid formation (raised and thickened scars), atrophic dermatitis (extreme skin irritation or itchiness) or immunologic abnormalities such as vitiligo (white patches of skin due to loss of pigment)
- Have been treated with lasers, chemical procedures, or other cosmetic procedures on the area to be treated within 6 months of enrollment
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Atrophic Acne Scars With a Fractional CO2 Laser at 1 Versus 3 Months Intervals. A Randomized Controlled Trial With Blinded Response Evaluations
To compare efficacy and adverse effects of fractional CO2 laser of acne scars treatment with 1 versus 3 months intervals
Read the detailed description
Change in scar texture evaluated by blinded evalutaions. Appearance of erythema, oedema, pigmentation, infection after treatment
- Conditions
- Atrophic Acne Scars
- Being tested
- Laser
- Keywords
- skin texture, efficacy, adverse effects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LaserProcedure or surgery
Also called Fractionel CO2 laser
Fractionel CO2 laser: 1 versus 3 months intervals
| Study group | Role | What they receive |
|---|---|---|
| CO2 laser at 1 month interval | Active comparator | CO2 laser treatment of mild to severe acne scars at 1 month interval Receives: Procedure: Laser |
| CO2 laser at 3 monrths interval | Active comparator | CO2 laser treatment of mild to severe acne scars at 3 month intervals Receives: Procedure: Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in scar texture
Measured: 24 weeks
Secondary outcomes (1)
Appearance of erythema, oedema, pigmentation, infection
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2013 (estimated)
- Study startNov 2011
- Primary completionJan 2013 (estimated)
- Study completionJan 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrophic Acne ScarsStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lene Hedelund, MD, PhD, Study director, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01773343
- Sponsor's protocol ID
- 100169
- Other IDs
- 20110102
- Status last verified
- Jan 2013
- First submitted
- 2 Jan 2013
- Last updated
- 23 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Atrophic Acne Scars With a Fractional CO2 Laser at 1 Versus 3 Months Intervals. A Randomized Controlled Trial With Blinded Response Evaluations
- ClinicalTrials.gov ID
- NCT01773343
- Acronym / sponsor ID
- 100169
- Conditions
- Atrophic Acne Scars
- Keywords
- skin texture, efficacy, adverse effects
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Jan 2013 (estimated)
- Study completion
- Jan 2013 (estimated)
- First posted
- 23 Jan 2013 (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.
To compare efficacy and adverse effects of fractional CO2 laser of acne scars treatment with 1 versus 3 months intervals
Detailed description
Change in scar texture evaluated by blinded evalutaions. Appearance of erythema, oedema, pigmentation, infection after treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CO2 laser at 1 month interval | Active comparator | Procedure: LaserCO2 laser treatment of mild to severe acne scars at 1 month interval |
| CO2 laser at 3 monrths interval | Active comparator | Procedure: LaserCO2 laser treatment of mild to severe acne scars at 3 month intervals |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Have Fitzpatrick skin type I-III. (•Are male or female.
- Are between 18 and 60 years of age.
- Mild to severe acne scarring.
- Are able to read, understand, and sign the Informed Consent.
- Are willing and able to comply with all follow-up requirements -
Key exclusion criteria (4 listed)
- Have had active localized or systemic infections within 6 months of enrollment
- Have compromised ability for wound healing, such as: malnutrition, oral steroid use, history of collagen vascular disease (e.g. lupus, scleroderma, history of keloid formation (raised and thickened scars), atrophic dermatitis (extreme skin irritation or itchiness) or immunologic abnormalities such as vitiligo (white patches of skin due to loss of pigment)
- Have been treated with lasers, chemical procedures, or other cosmetic procedures on the area to be treated within 6 months of enrollment
- Pregnancy
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 |
|---|---|---|
| LaserAlso: Fractionel CO2 laserFractionel CO2 laser: 1 versus 3 months intervals | Procedure or surgery | CO2 laser at 1 month interval, CO2 laser at 3 monrths interval |
Primary outcome
Change in scar texture
Time frame: 24 weeks
1 secondary outcome
Appearance of erythema, oedema, pigmentation, infection
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2013.
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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.
Lene Hedelund, MD, PhD study director
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser in people with Atrophic Acne Scars, run by Aarhus University Hospital at 1 site in Denmark.
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 5 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: status not confirmed, as of the sponsor's last update on 23 Jan 2013. 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 Denmark. 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?
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 in scar texture (time frame: 24 weeks). 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 23 Jan 2013.