AcneNCT02955381
Restylane Silk Acne Scar Efficacy Evaluation Study
A study testing Restylane Silk, 1.0 ml and Saline, 1.0 ml in people with Acne and Acne Scars, run by Schweiger Dermatology, PLLC at 1 site in United States.
Trial summary
Randomized, double-blind, placebo-controlled, research pilot study. 30 subjects aged 22-55 years old of all skin types will be asked to sign an informed consent form prior to any study procedures. Subjects must have at least 1 but up to 3 acne scars ≥3 mm or ≤ 10 mm located on the cheeks or forehead. Read more about this study
- Who is it for?
- Ages 22 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne, Acne Scars, AdverseEvent
- What is being tested?
- Restylane Silk, 1.0 ml and Saline, 1.0 ml
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Mar 2017to 18 Apr 2019
- 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 22 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or non-pregnant female subjects on an acceptable form of birth control aged 22-55 years of age.
- Willing to refrain from undergoing any procedures to repair or augment any acne scar in the treatment area during the study.
- Female subjects with a negative pregnancy test confirmed at screening and on an acceptable form of birth control. Acceptable forms of birth control on this study include oral or injectable contraceptive, contraceptive patches, Depo-Provera, NuvaRing, Implanon, double barrier methods, IUD, same sex partner, or abstinence. Males will be required to use an acceptable method of birth control: vasectomy, double-barrier method, condom with spermicidal lube, or abstinence.
- Signed informed consent prior to conducting any study procedures.
- Willing to refrain from undergoing any cosmetic procedures in the treatment area during the study.
- At least one acne scar located on the cheeks or forehead to be ≥ 3 mm and ≤ 10 mm in diameter, and rated as ≥3 on the ASRS at day 0. Subjects may have up to three qualifying acne scars determined eligible for treatment at screening.
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- Acne scars that are classified as either ice pick, rolling, or boxcar acne scars.
- ≤15 pustules/papules on the face at the time of screening and ≤ 2 nodules, and no cysts at Baseline.
- Willing to attend all study visits and comply with protocol
Who cannot join
- Subjects with active cystic acne at screening (> 2 nodules or any cysts present at Baseline).
- Use of antibiotics 2-weeks prior to screening.
- Use of retinoids 2-weeks prior to screening.
- Use of salicylic acid or benzoyl peroxide 7 days prior to screening.
- Excessive facial hair, skin conditions, facial tattoos, or other dermatologic marks that would obscure the treatment area.
- Use of Isotretinoin (Accutane) 6 months prior to screening.
Show all 21Show fewer
- Semi-permanent or permanent injection in the face 3 months prior to screening.
- History of bleeding disorders.
- Use of blood thinners (i.e warfarin (Coumadin), clopidogrel bisulfate (Plavix), etc.) 1 month prior to screening.
- Acne scars that are considered post-inflammatory erythematous, post-inflammatory hyperpigmentation, varicella (chicken pox) scars, or perifollicular elastolysis will not be allowed to be identified as the target acne scars. These types of scars are still allowed to be present but cannot be selected.
- Acne scars that are located in the glabella and temple regions. Acne scars located in these regions will not be allowed to be selected as a target or additional acne scar. As well, scars located in these areas will not be allowed to be treated during the study. Subjects are allowed to have acne scars located in these areas but cannot have them selected for evaluation or treated during the study.
- Laser or light (red and blue) treatments for acne 3 months prior to screening.
- Resurfacing procedures (CO2 , Erbium, Fraxel, etc.) performed 6 months prior to screening.
- Any chemical peels in the last 30 days prior to screening.
- Hypersensitivity to amid-type local anesthetics.
- Any cortisol steroid or ILK injection 30 days prior to screening
- Subjects with a history of diabetes.
- Any medical condition or diagnosis which in the investigator's opinion would disqualify them from the research study.
- History of abuse with the use of alcohol or drugs.
- Participation in a clinical trial or use of an investigational product in the past 30 days.
- Subjects who are considered health risks for participation in the study or the investigator determines not to be suitable.
Trial locations and contacts
1 site in 1 country.
United States1 site
Schweiger Dermatology, PLLC
New York, New York, 10022
About this study
Official title: 6 Month Double-Blind Randomized Placebo-Controlled Trial to Evaluate the Safety and Efficacy of Small Particle Hyaluronic Acid to Treat Acne Scars Located on the Cheeks and Forehead
Randomized, double-blind, placebo-controlled, research pilot study. 30 subjects aged 22-55 years old of all skin types will be asked to sign an informed consent form prior to any study procedures. Subjects must have at least 1 but up to 3 acne scars ≥3 mm or ≤ 10 mm located on the cheeks or forehead. Subjects will receive one treatment (Restylane® Silk or Placebo) in each scar at day 0, and Month 1 (2 total treatments per scar during the study). Subjects will be asked to come to 10 visits: Screening visit (up to 35 days prior to Baseline), Baseline (Day 0), Day 7, Day 14, Month 1, Month 2, Month 3, Month 4, Month 5, and Month 6 (study exit visit). The treatment area will be evaluated at each visit by the unblinded investigator regarding erythema, bruising, inflammation, itching, stinging/burning, brightness, fullness, smoothness, and clarity. Safety and adverse events will be captured at each visit only by the unblinded investigator.
Read the detailed description
Randomized, double-blind, placebo-controlled, research pilot study. 30 subjects aged 22-55 years old of all skin types will be asked to sign an informed consent form prior to any study procedures. Subjects must have at least 1 but up to 3 acne scars ≥3 mm or ≤ 10 mm located on the cheeks or forehead. Subjects will receive one treatment (Restylane® Silk or Placebo) in each scar at day 0, and Month 1 (2 total treatments per scar during the study). Subjects will be asked to come to 10 visits: Screening visit (up to 35 days prior to Baseline), Baseline (Day 0), Day 7, Day 14, Month 1, Month 2, Month 3, Month 4, Month 5, and Month 6 (study exit visit). The blinded investigators will evaluate the target scar using the Acne Scar Rating Scale (ASRS), rate the target acne scar regarding treatment effect on a -5 ("Markedly worse"), to 0 ("Neutral Improvement"), to 5 (Markedly Improved (Clear or nearly clear)) point scale, and evaluate the skin quality (regarding brightness, fullness, smoothness, and clarity). Subjects will give the acne scar a score on the subject VAS acne scar satisfaction scale marking between 0 ("Not satisfied with Acne Scar at Day 0") and 10 ("Extremely Satisfied with Acne Scar at Day 0"). The treatment area will be evaluated at each visit by the unblinded investigator regarding erythema, bruising, inflammation, itching, stinging/burning, brightness, fullness, smoothness, and clarity. The subject will have their vital signs taken, complete a symptom diary (only if the subject experiences side effects or adverse events), complete a DLQI, and have photos (VECTRA and 2D digital photographs) taken of the treatment area. Efficacy measures will only be completed by the blinded investigator. Safety and adverse events will be captured at each visit only by the unblinded investigator.
- Conditions
- Acne, Acne Scars, AdverseEvent
- Being tested
- Restylane Silk, 1.0 ml, Saline, 1.0 ml
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restylane Silk, 1.0 mlDevice
Restylane® Silk was approved in 2014 submucosal implantation for lip augmentation and dermal implantation for correction of perioral rhytids in patients over the age of 21.
Saline, 1.0 mlDevice
Simple saline solution. To be used as placebo (control). No active ingredients.
| Study group | Role | What they receive |
|---|---|---|
| Restylane Silk, 1.0 ml | Experimental | Subjects must have at least 1 but up to 3 acne scars ≥3 mm and ≤ 10 mm located on the cheeks or forehead. Subjects will receive one treatment (Restylane® Silk) in each scar (up to 3 acne scars) at day 0, and Month 1 (2 total treatments per scar during the study). Subjects will remain blinded to the treatment administered to them during these visits. Receives: Device: Restylane Silk, 1.0 ml |
| Placebo (Saline), 1.0 ml | Placebo comparator | Subjects must have at least 1 but up to 3 acne scars ≥3 mm and ≤ 10 mm located on the cheeks or forehead. Subjects will receive one treatment (Placebo (Saline)) in each scar (up to 3 acne scars) at day 0, and Month 1 (2 total treatments per scar during the study). Subjects will remain blinded to the treatment administered to them during these visits. Receives: Device: Saline, 1.0 ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
1 grade improvement of ASRS from baseline
The primary endpoint is a one grade improvement of the acne scar from baseline as rated on the ASRS.
Measured: Baseline-6 Months post first injection.
Secondary outcomes (2)
Statistically significant improvement of the acne scar from baseline
A significant improvement of the acne scar from baseline as rated by the
Measured: Baseline-6 Months post first injection.
Statistically significant improvement of the skin quality from baseline
A significant improvement of the skin quality of the treatment area as rated by the investigator using the skin quality assessment scale.
Measured: Baseline-6 Months post first injection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2016 (estimated)
- Study start28 Mar 2017
- Primary completion18 Apr 2019
- Study completion18 Apr 2019
Why it stopped: Liquidation of Research Department
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for AcneStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Schweiger Dermatology, PLLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eric S Schweiger, M.D., Principal investigator, CEO & Chief Medical OfficerMargaret J Tropeano, BS, Study director, Clinical Research Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02955381
- Sponsor's protocol ID
- SDG 02-2016
- Status last verified
- May 2019
- First submitted
- 2 Nov 2016
- Last updated
- 10 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: This is an investigator initiated study and will use the primary data to create a final data report. Individual patient data will not be available to other researchers.
Publications
Fife D. Practical evaluation and management of atrophic acne scars: tips for the general dermatologist. J Clin Aesthet Dermatol. 2011 Aug;4(8):50-7.
PubMed 21909457Brandt FS, Cazzaniga A. Hyaluronic acid gel fillers in the management of facial aging. Clin Interv Aging. 2008;3(1):153-9. doi: 10.2147/cia.s2135.
PubMed 18488885Layton AM, Henderson CA, Cunliffe WJ. A clinical evaluation of acne scarring and its incidence. Clin Exp Dermatol. 1994 Jul;19(4):303-8. doi: 10.1111/j.1365-2230.1994.tb01200.x.
PubMed 7955470Koo JY, Smith LL. Psychologic aspects of acne. Pediatr Dermatol. 1991 Sep;8(3):185-8. doi: 10.1111/j.1525-1470.1991.tb00856.x.
PubMed 1836060Rivera AE. Acne scarring: a review and current treatment modalities. J Am Acad Dermatol. 2008 Oct;59(4):659-76. doi: 10.1016/j.jaad.2008.05.029. Epub 2008 Jul 26.
PubMed 18662839Tsao SS, Dover JS, Arndt KA, Kaminer MS. Scar management: keloid, hypertrophic, atrophic, and acne scars. Semin Cutan Med Surg. 2002 Mar;21(1):46-75. doi: 10.1016/s1085-5629(02)80719-2. No abstract available.
PubMed 11911537Jacob CI, Dover JS, Kaminer MS. Acne scarring: a classification system and review of treatment options. J Am Acad Dermatol. 2001 Jul;45(1):109-17. doi: 10.1067/mjd.2001.113451.
PubMed 11423843Sadick NS, Palmisano L. Case study involving use of injectable poly-L-lactic acid (PLLA) for acne scars. J Dermatolog Treat. 2009;20(5):302-7. doi: 10.1080/09546630902817879.
PubMed 19340629Lizzul PF, Narurkar VA. The role of calcium hydroxylapatite (Radiesse) in nonsurgical aesthetic rejuvenation. J Drugs Dermatol. 2010 May;9(5):446-50.
PubMed 20480786Brandt FS, Cazzaniga A. Hyaluronic acid fillers: Restylane and Perlane. Facial Plast Surg Clin North Am. 2007 Feb;15(1):63-76, vii. doi: 10.1016/j.fsc.2006.11.002.
PubMed 17317557Fife D, Zachary CB. Combining techniques for treating acne scars. Current Dermatology Reports. 2012;1:82-88.
Werschler, Phillip, et al.
Cohen JL. Understanding, avoiding, and managing dermal filler complications. Dermatol Surg. 2008 Jun;34 Suppl 1:S92-9. doi: 10.1111/j.1524-4725.2008.34249.x.
PubMed 18547189Hession MT, Graber EM. Atrophic acne scarring: a review of treatment options. J Clin Aesthet Dermatol. 2015 Jan;8(1):50-8.
PubMed 25610524Duranti F, Salti G, Bovani B, Calandra M, Rosati ML. Injectable hyaluronic acid gel for soft tissue augmentation. A clinical and histological study. Dermatol Surg. 1998 Dec;24(12):1317-25. doi: 10.1111/j.1524-4725.1998.tb00007.x.
PubMed 9865196
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 6 Month Double-Blind Randomized Placebo-Controlled Trial to Evaluate the Safety and Efficacy of Small Particle Hyaluronic Acid to Treat Acne Scars Located on the Cheeks and Forehead
- ClinicalTrials.gov ID
- NCT02955381
- Acronym / sponsor ID
- SDG 02-2016
- Conditions
- Acne, Acne Scars, AdverseEvent
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Liquidation of Research Department
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Schweiger Dermatology, PLLCIndustry (pharma, biotech, devices)
- Study start
- 28 Mar 2017 (actual)
- Primary completion
- 18 Apr 2019 (actual)
- Study completion
- 18 Apr 2019 (actual)
- First posted
- 4 Nov 2016 (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.
Randomized, double-blind, placebo-controlled, research pilot study. 30 subjects aged 22-55 years old of all skin types will be asked to sign an informed consent form prior to any study procedures. Subjects must have at least 1 but up to 3 acne scars ≥3 mm or ≤ 10 mm located on the cheeks or forehead. Subjects will receive one treatment (Restylane® Silk or Placebo) in each scar at day 0, and Month 1 (2 total treatments per scar during the study). Subjects will be asked to come to 10 visits: Screening visit (up to 35 days prior to Baseline), Baseline (Day 0), Day 7, Day 14, Month 1, Month 2, Month 3, Month 4, Month 5, and Month 6 (study exit visit). The treatment area will be evaluated at each visit by the unblinded investigator regarding erythema, bruising, inflammation, itching, stinging/burning, brightness, fullness, smoothness, and clarity. Safety and adverse events will be captured at each visit only by the unblinded investigator.
Detailed description
Randomized, double-blind, placebo-controlled, research pilot study. 30 subjects aged 22-55 years old of all skin types will be asked to sign an informed consent form prior to any study procedures. Subjects must have at least 1 but up to 3 acne scars ≥3 mm or ≤ 10 mm located on the cheeks or forehead. Subjects will receive one treatment (Restylane® Silk or Placebo) in each scar at day 0, and Month 1 (2 total treatments per scar during the study). Subjects will be asked to come to 10 visits: Screening visit (up to 35 days prior to Baseline), Baseline (Day 0), Day 7, Day 14, Month 1, Month 2, Month 3, Month 4, Month 5, and Month 6 (study exit visit). The blinded investigators will evaluate the target scar using the Acne Scar Rating Scale (ASRS), rate the target acne scar regarding treatment effect on a -5 ("Markedly worse"), to 0 ("Neutral Improvement"), to 5 (Markedly Improved (Clear or nearly clear)) point scale, and evaluate the skin quality (regarding brightness, fullness, smoothness, and clarity). Subjects will give the acne scar a score on the subject VAS acne scar satisfaction scale marking between 0 ("Not satisfied with Acne Scar at Day 0") and 10 ("Extremely Satisfied with Acne Scar at Day 0"). The treatment area will be evaluated at each visit by the unblinded investigator regarding erythema, bruising, inflammation, itching, stinging/burning, brightness, fullness, smoothness, and clarity. The subject will have their vital signs taken, complete a symptom diary (only if the subject experiences side effects or adverse events), complete a DLQI, and have photos (VECTRA and 2D digital photographs) taken of the treatment area. Efficacy measures will only be completed by the blinded investigator. Safety and adverse events will be captured at each visit only by the unblinded investigator.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Restylane Silk, 1.0 ml | Experimental | Device: Restylane Silk, 1.0 mlSubjects must have at least 1 but up to 3 acne scars ≥3 mm and ≤ 10 mm located on the cheeks or forehead. Subjects will receive one treatment (Restylane® Silk) in each scar (up to 3 acne scars) at day 0, and Month 1 (2 total treatments per scar during the study). Subjects will remain blinded to the treatment administered to them during these visits. |
| Placebo (Saline), 1.0 ml | Placebo comparator | Device: Saline, 1.0 mlSubjects must have at least 1 but up to 3 acne scars ≥3 mm and ≤ 10 mm located on the cheeks or forehead. Subjects will receive one treatment (Placebo (Saline)) in each scar (up to 3 acne scars) at day 0, and Month 1 (2 total treatments per scar during the study). Subjects will remain blinded to the treatment administered to them during these visits. |
Who may qualify
- Ages
- 22 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Male or non-pregnant female subjects on an acceptable form of birth control aged 22-55 years of age.
- Willing to refrain from undergoing any procedures to repair or augment any acne scar in the treatment area during the study.
- Female subjects with a negative pregnancy test confirmed at screening and on an acceptable form of birth control. Acceptable forms of birth control on this study include oral or injectable contraceptive, contraceptive patches, Depo-Provera, NuvaRing, Implanon, double barrier methods, IUD, same sex partner, or abstinence. Males will be required to use an acceptable method of birth control: vasectomy, double-barrier method, condom with spermicidal lube, or abstinence.
- Signed informed consent prior to conducting any study procedures.
- Willing to refrain from undergoing any cosmetic procedures in the treatment area during the study.
Key exclusion criteria (21 listed)
- Subjects with active cystic acne at screening (> 2 nodules or any cysts present at Baseline).
- Use of antibiotics 2-weeks prior to screening.
- Use of retinoids 2-weeks prior to screening.
- Use of salicylic acid or benzoyl peroxide 7 days prior to screening.
- Excessive facial hair, skin conditions, facial tattoos, or other dermatologic marks that would obscure the treatment area.
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 |
|---|---|---|
| Restylane Silk, 1.0 mlRestylane® Silk was approved in 2014 submucosal implantation for lip augmentation and dermal implantation for correction of perioral rhytids in patients over the age of 21. | Device | Restylane Silk, 1.0 ml |
| Saline, 1.0 mlSimple saline solution. To be used as placebo (control). No active ingredients. | Device | Placebo (Saline), 1.0 ml |
Primary outcome
1 grade improvement of ASRS from baseline
Time frame: Baseline-6 Months post first injection.
The primary endpoint is a one grade improvement of the acne scar from baseline as rated on the ASRS.
2 secondary outcomes
Statistically significant improvement of the acne scar from baseline
Time frame: Baseline-6 Months post first injection.
Statistically significant improvement of the skin quality from baseline
Time frame: Baseline-6 Months post first injection.
Results and safety
The study was stopped early (reason given: Liquidation of Research Department). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2019.
- Background: PubMed 21909457Fife D. Practical evaluation and management of atrophic acne scars: tips for the general dermatologist. J Clin Aesthet Dermatol. 2011 Aug;4(8):50-7.
- Background: PubMed 18488885Brandt FS, Cazzaniga A. Hyaluronic acid gel fillers in the management of facial aging. Clin Interv Aging. 2008;3(1):153-9. doi: 10.2147/cia.s2135.
- Background: PubMed 7955470Layton AM, Henderson CA, Cunliffe WJ. A clinical evaluation of acne scarring and its incidence. Clin Exp Dermatol. 1994 Jul;19(4):303-8. doi: 10.1111/j.1365-2230.1994.tb01200.x.
- Background: PubMed 1836060Koo JY, Smith LL. Psychologic aspects of acne. Pediatr Dermatol. 1991 Sep;8(3):185-8. doi: 10.1111/j.1525-1470.1991.tb00856.x.
- Background: PubMed 18662839Rivera AE. Acne scarring: a review and current treatment modalities. J Am Acad Dermatol. 2008 Oct;59(4):659-76. doi: 10.1016/j.jaad.2008.05.029. Epub 2008 Jul 26.
- Background: PubMed 11911537Tsao SS, Dover JS, Arndt KA, Kaminer MS. Scar management: keloid, hypertrophic, atrophic, and acne scars. Semin Cutan Med Surg. 2002 Mar;21(1):46-75. doi: 10.1016/s1085-5629(02)80719-2. No abstract available.
- Background: PubMed 11423843Jacob CI, Dover JS, Kaminer MS. Acne scarring: a classification system and review of treatment options. J Am Acad Dermatol. 2001 Jul;45(1):109-17. doi: 10.1067/mjd.2001.113451.
- Background: PubMed 19340629Sadick NS, Palmisano L. Case study involving use of injectable poly-L-lactic acid (PLLA) for acne scars. J Dermatolog Treat. 2009;20(5):302-7. doi: 10.1080/09546630902817879.
- Background: PubMed 20480786Lizzul PF, Narurkar VA. The role of calcium hydroxylapatite (Radiesse) in nonsurgical aesthetic rejuvenation. J Drugs Dermatol. 2010 May;9(5):446-50.
- Background: PubMed 17317557Brandt FS, Cazzaniga A. Hyaluronic acid fillers: Restylane and Perlane. Facial Plast Surg Clin North Am. 2007 Feb;15(1):63-76, vii. doi: 10.1016/j.fsc.2006.11.002.
- BackgroundFife D, Zachary CB. Combining techniques for treating acne scars. Current Dermatology Reports. 2012;1:82-88.
- BackgroundWerschler, Phillip, et al.
- Individual participant dataSharing planned: No. This is an investigator initiated study and will use the primary data to create a final data report. Individual patient data will not be available to other researchers.
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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.
Eric S Schweiger, M.D. principal investigator
CEO & Chief Medical Officer
Margaret J Tropeano, BS study director
Clinical Research Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Restylane Silk, 1.0 ml and Saline, 1.0 ml in people with Acne and Acne Scars, run by Schweiger Dermatology, PLLC 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 9 inclusion and 21 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 10 May 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 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.
Are results available for this study?
The study was stopped early (reason given: Liquidation of Research Department). 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?
1 grade improvement of ASRS from baseline (time frame: Baseline-6 Months post first injection.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02955381, which also lists 16 linked publications.
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 10 May 2019.