ScarPhase 2/3NCT03887377
The Efficacy and Molecular Mechanism of Botulinum Toxin in the Reduction of Breast Reduction Mammoplasty Scar Formation
A Phase 2/3 study testing Botulinum Toxins and Normal saline in people with Scar and Hypertrophic Scar, run by Henry Ford Health System at 1 site in United States.
Trial summary
1. Test the ability of botulinum toxin type A, when injected into the surgical incision at the time of surgery, to decrease postoperative scar scores compared to control (normal saline) in a double-blinded randomized control trial. 2. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Scar, Hypertrophic Scar, Mammary Disorder
- What is being tested?
- Botulinum Toxins and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2019to 30 Dec 2024
- Phase
- Phase 2/3
- 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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Undergoing breast reduction surgery
- Does not meet any exclusion criteria
- Female
- >18 years old
- Willing to participate in study
Who cannot join
- Allergy to botulinum toxin
- Currently pregnant or breast feeding
- Myasthenia gravis
- Lambert-Eaton Myasthenic Syndrome
- Amyopathic Lateral Sclerosis
- Previous injection of botulinum toxin in the chest area within 6 months prior to enrollment
Show all 13Show fewer
- History of keloid or hypertrophic scar
- History of previous breast surgery with scar affecting inframammary skin
- Male Sex
- Refusal to participate in the study
- Unable to make follow up appointments up to 6 months
- Less than 18 years of age
- History of radiation to the breast
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy and Molecular Mechanism of Botulinum Toxin in the Reduction of Breast Reduction Mammoplasty Scar Formation: A Prospective, Controlled, Randomized, Double-blinded Study
- Test the ability of botulinum toxin type A, when injected into the surgical incision at the time of surgery, to decrease postoperative scar scores compared to control (normal saline) in a double-blinded randomized control trial.
- Investigate the mechanism of BTXa effects of scar formation by measuring micro RNA profiles at two time points in the healing process.
Read the detailed description
Breast reduction mammoplasty is an increasingly popular procedure in this country due to not only the perceived cosmetic benefit of the procedure but additionally the improvement in musculoskeletal pain, headaches, sleeping difficulties, breathing, depression, self-esteem, and eating disorders. Despite these benefits, outcome satisfaction the typical inverted-T scar of the Wise pattern reduction has been limited by the resulting scar formation on the breast tissue. One study demonstrated that although 86% of patients were highly satisfied with their surgery, 65% were dissatisfied with their scars, with the majority of those dissatisfied , 65%, being bothered by the horizontal component of the scar. To address cosmetic outcomes of the procedure multiple techniques have been purposed in the literature including: superior pedicle technique, vertical mammoplasty, and circum-areolar breast reduction. By selectively injecting the horizontal component of the mammoplasty scar our analysis should be independent of surgeon surgical approach if it should include a vertical incisional scar. Aesthetic results of breast mammoplasty have also been attributed to analysis of breast meridian length, modifying areolar shape and most importantly tailoring or the medial inframammary crease. Tension across the inframammary crease requires appropriate shaping in order to reduce scar hypertrophy.
Mechanical stress from wound tension has been thought to play a major role in hypertrophic scar development. Cellular and biochemical studies have demonstrated that excessive forces on tissues are tightly linked to changes in the extracellular matrix such as the induction of wound fibrosis and inhibition of fibroblast apoptosis. Recently, botulinum toxin type A has been reported as a treatment agent to counteract these effects. Although its precise mechanism is not yet completely understood, botulinum toxin type A is thought to promote apoptosis of fibroblasts derived from hypertrophic scars, leading to reduced tensile forces. In an in vivo study, human hypertrophic scars treated with botulinum toxin type A had significantly reduced fibroblast proliferation compared to a control, and had synergistic effects with intralesional steroid injections, which is a commonly used treatment but with multiple adverse effects.
Botulinum toxin type A is a potent neurotoxin used in a wide scope of clinical settings, and has been injected for cosmetic purposes for more than two decades. Its clinical use specifically for hypertrophic scars, including those of the face, has recently been demonstrated. Furthermore, a randomized double-blinded split scar study has demonstrated the safety and efficacy of botulinum toxin type A injection into thyroidectomy scars for scar prevention. Although a well-controlled and designed study, its weaknesses include the difficult applicability of the Korean population to that of the United States, the relatively small number of patients included in the trial, the injection of botulinum toxin type A post-surgery instead of at the time of surgery (as the latter is often reported in other studies and is thought to be more beneficial). This protocol is designed to test the ability of botulinum toxin type A to improve post-surgical breast scarring in a randomized, double-blinded, controlled clinical trial at Henry Ford Hospital. It expands upon previous studies that have already demonstrated its safety and good tolerance profile, and will combine the expertise of the Dermatology department and Plastic surgeons. We will study breast reduction scars, as this will allow patients to serve as their own control group.
- Conditions
- Scar, Hypertrophic Scar, Mammary Disorder
- Being tested
- Botulinum Toxins, Normal saline
- Keywords
- macromastia, botulinum toxin, scar prevention, scar formation
- Medical subject headings
- Cicatrix, Cicatrix, Hypertrophic, Breast Diseases, Gigantomastia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum ToxinsDrug
Also called Dysport, BTXa, abobotulinumtoxinA
We will be comparing botulinum toxin following breast reduction surgery to placebo injection. We will then compare photos of each breast reduction scar at set intervals following surgery.
Normal salineOther
Also called Placebo
Normal saline will serve as the placebo control on the contralateral breast
| Study group | Role | What they receive |
|---|---|---|
| Breast receiving botulinum toxin | Experimental | Following reconstruction one horizontal incisional wound will be selected to receive a series of botulinum toxin injections along the wound.
Injection abobotulinum toxin at time of surgery, single injection time with 30 gauge needle superficially, dosage determined by length of scar 5-15U per cm Receives: Drug: Botulinum Toxins |
| Breast receiving placebo | Placebo comparator | The other breast will be injected with bacteriostatic normal saline in a similar fashion to the other breast. The injector will be blinded to the contents of the syringe. Receives: Other: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Patient and Observer Scar Assessment Scale v2.0 (POSAS)
Two blinded dermatologists will make the objective clinical assessments separately using a modified POSAS Patient and Observer Scar Assessment Scale v2.0
It includes assessing the vascularity, pigmentation, thickness, relief, and surface area from a scale from 1 to 10. Pliability, which is included in the original scale, will be excluded for this study given the use of photographs for assessment. The scale also includes the patient's opinion of their own scar, which includes pain, pruritis, color, stiffness, thickness, irregularity from a scale from 1 to 10.Independent objective review of scar photos will be graded on a scale 1-10. 1 is normal skin. 10 is worst scar imaginable.
Measured: Photos will be reviewed at the 1 week follow surgery
Modified Patient and Observer Scar Assessment Scale v2.0 (POSAS)
Two blinded dermatologists will make the objective clinical assessments separately using a modified POSAS Patient and Observer Scar Assessment Scale v2.0
It includes assessing the vascularity, pigmentation, thickness, relief, and surface area from a scale from 1 to 10. Pliability, which is included in the original scale, will be excluded for this study given the use of photographs for assessment. The scale also includes the patient's opinion of their own scar, which includes pain, pruritis, color, stiffness, thickness, irregularity from a scale from 1 to 10.Independent objective review of scar photos will be graded on a scale 1-10. 1 is normal skin. 10 is worst scar imaginable.
These scores will be compared to the 1 week time point.
Measured: 4-8 weeks following surgery
Modified Patient and Observer Scar Assessment Scale v2.0 (POSAS)
Two blinded dermatologists will make the objective clinical assessments separately using a modified POSAS Patient and Observer Scar Assessment Scale v2.0
It includes assessing the vascularity, pigmentation, thickness, relief, and surface area from a scale from 1 to 10. Pliability, which is included in the original scale, will be excluded for this study given the use of photographs for assessment. The scale also includes the patient's opinion of their own scar, which includes pain, pruritis, color, stiffness, thickness, irregularity from a scale from 1 to 10.Independent objective review of scar photos will be graded on a scale 1-10. 1 is normal skin. 10 is worst scar imaginable.
These scores will be compared to the 1 week and the 4-8 weeks time point.
Measured: 6 month mark following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2019
- Study start10 Jun 2019
- Primary completion30 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for ScarStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Each patient will serve as their own control as one breast incision will be injected with botulinum toxin type A while the other will receive placebo.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Galderma R&D
- Responsible party
- Principal investigator, David M. Ozog, Henry Ford Health System
- Investigators
- David Ozog, MD, Principal investigator, Henry Ford Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03887377
- Sponsor's protocol ID
- 12373
- Status last verified
- Jun 2025
- First submitted
- 20 Feb 2019
- Last updated
- 15 Jun 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There will be a publication based on the results of the study. We will not be sharing individual participant data outside of our facility. All data will be kept on the secure drive at Henry Ford Health Systems.
Publications
Singh KA, Losken A. Additional benefits of reduction mammaplasty: a systematic review of the literature. Plast Reconstr Surg. 2012 Mar;129(3):562-570. doi: 10.1097/PRS.0b013e31824129ee.
PubMed 22090252Sprole AM, Adepoju I, Ascherman J, Gayle LB, Grant RT, Talmor M. Horizontal or vertical? an evaluation of patient preferences for reduction mammaplasty scars. Aesthet Surg J. 2007 May-Jun;27(3):257-62. doi: 10.1016/j.asj.2007.04.007.
PubMed 19341651Saleem L, John JR. Unfavourable results following reduction mammoplasty. Indian J Plast Surg. 2013 May;46(2):401-7. doi: 10.4103/0970-0358.118620.
PubMed 24501476Hidalgo DA. Improving safety and aesthetic results in inverted T scar breast reduction. Plast Reconstr Surg. 1999 Mar;103(3):874-86; discussion 887-9.
PubMed 10077078Wolfram D, Tzankov A, Pulzl P, Piza-Katzer H. Hypertrophic scars and keloids--a review of their pathophysiology, risk factors, and therapeutic management. Dermatol Surg. 2009 Feb;35(2):171-81. doi: 10.1111/j.1524-4725.2008.34406.x.
PubMed 19215252Niland S, Cremer A, Fluck J, Eble JA, Krieg T, Sollberg S. Contraction-dependent apoptosis of normal dermal fibroblasts. J Invest Dermatol. 2001 May;116(5):686-92. doi: 10.1046/j.1523-1747.2001.01342.x.
PubMed 11348456Chen CS. Mechanotransduction - a field pulling together? J Cell Sci. 2008 Oct 15;121(Pt 20):3285-92. doi: 10.1242/jcs.023507.
PubMed 18843115Gabbiani G. The myofibroblast in wound healing and fibrocontractive diseases. J Pathol. 2003 Jul;200(4):500-3. doi: 10.1002/path.1427.
PubMed 12845617Zhibo X, Miaobo Z. Botulinum toxin type A affects cell cycle distribution of fibroblasts derived from hypertrophic scar. J Plast Reconstr Aesthet Surg. 2008 Sep;61(9):1128-9. doi: 10.1016/j.bjps.2008.05.003. Epub 2008 Jun 13. No abstract available.
PubMed 18555763Zhibo X, Miaobo Z. Potential therapeutical effects of botulinum toxin type A in keloid management. Med Hypotheses. 2008 Oct;71(4):623. doi: 10.1016/j.mehy.2008.04.018. Epub 2008 Jun 4. No abstract available.
PubMed 18534768Xiao Z, Zhang F, Lin W, Zhang M, Liu Y. Effect of botulinum toxin type A on transforming growth factor beta1 in fibroblasts derived from hypertrophic scar: a preliminary report. Aesthetic Plast Surg. 2010 Aug;34(4):424-7. doi: 10.1007/s00266-009-9423-z. Epub 2009 Oct 3.
PubMed 19802513Chen HC, Yen CI, Yang SY, Chang CJ, Yang JY, Chang SY, Chuang SS, Hsiao YC. Comparison of Steroid and Botulinum Toxin Type A Monotherapy with Combination Therapy for Treating Human Hypertrophic Scars in an Animal Model. Plast Reconstr Surg. 2017 Jul;140(1):43e-49e. doi: 10.1097/PRS.0000000000003426.
PubMed 28654594Feily A, Fallahi H, Zandian D, Kalantar H. A succinct review of botulinum toxin in dermatology; update of cosmetic and noncosmetic use. J Cosmet Dermatol. 2011 Mar;10(1):58-67. doi: 10.1111/j.1473-2165.2010.00545.x.
PubMed 21332916Jablonka EM, Sherris DA, Gassner HG. Botulinum toxin to minimize facial scarring. Facial Plast Surg. 2012 Oct;28(5):525-35. doi: 10.1055/s-0032-1325641. Epub 2012 Oct 1.
PubMed 23027220Liu RK, Li CH, Zou SJ. Reducing scar formation after lip repair by injecting botulinum toxin. Plast Reconstr Surg. 2010 May;125(5):1573-1574. doi: 10.1097/PRS.0b013e3181d51404. No abstract available.
PubMed 20440184
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Molecular Mechanism of Botulinum Toxin in the Reduction of Breast Reduction Mammoplasty Scar Formation: A Prospective, Controlled, Randomized, Double-blinded Study
- ClinicalTrials.gov ID
- NCT03887377
- Acronym / sponsor ID
- 12373
- Conditions
- Scar, Hypertrophic Scar, Mammary Disorder
- Keywords
- macromastia, botulinum toxin, scar prevention, scar formation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Collaborators
- Galderma R&D
- Study start
- 10 Jun 2019 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 25 Mar 2019 (actual)
- 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.
- Test the ability of botulinum toxin type A, when injected into the surgical incision at the time of surgery, to decrease postoperative scar scores compared to control (normal saline) in a double-blinded randomized control trial.
- Investigate the mechanism of BTXa effects of scar formation by measuring micro RNA profiles at two time points in the healing process.
Detailed description
Breast reduction mammoplasty is an increasingly popular procedure in this country due to not only the perceived cosmetic benefit of the procedure but additionally the improvement in musculoskeletal pain, headaches, sleeping difficulties, breathing, depression, self-esteem, and eating disorders. Despite these benefits, outcome satisfaction the typical inverted-T scar of the Wise pattern reduction has been limited by the resulting scar formation on the breast tissue. One study demonstrated that although 86% of patients were highly satisfied with their surgery, 65% were dissatisfied with their scars, with the majority of those dissatisfied , 65%, being bothered by the horizontal component of the scar. To address cosmetic outcomes of the procedure multiple techniques have been purposed in the literature including: superior pedicle technique, vertical mammoplasty, and circum-areolar breast reduction. By selectively injecting the horizontal component of the mammoplasty scar our analysis should be independent of surgeon surgical approach if it should include a vertical incisional scar. Aesthetic results of breast mammoplasty have also been attributed to analysis of breast meridian length, modifying areolar shape and most importantly tailoring or the medial inframammary crease. Tension across the inframammary crease requires appropriate shaping in order to reduce scar hypertrophy.
Mechanical stress from wound tension has been thought to play a major role in hypertrophic scar development. Cellular and biochemical studies have demonstrated that excessive forces on tissues are tightly linked to changes in the extracellular matrix such as the induction of wound fibrosis and inhibition of fibroblast apoptosis. Recently, botulinum toxin type A has been reported as a treatment agent to counteract these effects. Although its precise mechanism is not yet completely understood, botulinum toxin type A is thought to promote apoptosis of fibroblasts derived from hypertrophic scars, leading to reduced tensile forces. In an in vivo study, human hypertrophic scars treated with botulinum toxin type A had significantly reduced fibroblast proliferation compared to a control, and had synergistic effects with intralesional steroid injections, which is a commonly used treatment but with multiple adverse effects.
Botulinum toxin type A is a potent neurotoxin used in a wide scope of clinical settings, and has been injected for cosmetic purposes for more than two decades. Its clinical use specifically for hypertrophic scars, including those of the face, has recently been demonstrated. Furthermore, a randomized double-blinded split scar study has demonstrated the safety and efficacy of botulinum toxin type A injection into thyroidectomy scars for scar prevention. Although a well-controlled and designed study, its weaknesses include the difficult applicability of the Korean population to that of the United States, the relatively small number of patients included in the trial, the injection of botulinum toxin type A post-surgery instead of at the time of surgery (as the latter is often reported in other studies and is thought to be more beneficial). This protocol is designed to test the ability of botulinum toxin type A to improve post-surgical breast scarring in a randomized, double-blinded, controlled clinical trial at Henry Ford Hospital. It expands upon previous studies that have already demonstrated its safety and good tolerance profile, and will combine the expertise of the Dermatology department and Plastic surgeons. We will study breast reduction scars, as this will allow patients to serve as their own control group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Each patient will serve as their own control as one breast incision will be injected with botulinum toxin type A while the other will receive placebo.
| Arm | Type | Receives |
|---|---|---|
| Breast receiving botulinum toxin | Experimental | Drug: Botulinum ToxinsFollowing reconstruction one horizontal incisional wound will be selected to receive a series of botulinum toxin injections along the wound. Injection abobotulinum toxin at time of surgery, single injection time with 30 gauge needle superficially, dosage determined by length of scar 5-15U per cm |
| Breast receiving placebo | Placebo comparator | Other: Normal salineThe other breast will be injected with bacteriostatic normal saline in a similar fashion to the other breast. The injector will be blinded to the contents of the syringe. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Undergoing breast reduction surgery
- Does not meet any exclusion criteria
- Female
- >18 years old
- Willing to participate in study
Key exclusion criteria (13 listed)
- Allergy to botulinum toxin
- Currently pregnant or breast feeding
- Myasthenia gravis
- Lambert-Eaton Myasthenic Syndrome
- Amyopathic Lateral Sclerosis
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 |
|---|---|---|
| Botulinum ToxinsAlso: Dysport, BTXa, abobotulinumtoxinAWe will be comparing botulinum toxin following breast reduction surgery to placebo injection. We will then compare photos of each breast reduction scar at set intervals following surgery. | Drug | Breast receiving botulinum toxin |
| Normal salineAlso: PlaceboNormal saline will serve as the placebo control on the contralateral breast | Other | Breast receiving placebo |
Primary outcome
Modified Patient and Observer Scar Assessment Scale v2.0 (POSAS)
Time frame: Photos will be reviewed at the 1 week follow surgery
Two blinded dermatologists will make the objective clinical assessments separately using a modified POSAS Patient and Observer Scar Assessment Scale v2.0 It includes assessing the vascularity, pigmentation, thickness, relief, and surface area from a scale from 1 to 10. Pliability, which is included in the original scale, will be excluded for this study given the use of photographs for assessment. The scale also includes the patient's opinion of their own scar, which includes pain, pruritis, color, stiffness, thickness, irregularity from a scale from 1 to 10.Independent objective review of scar photos will be graded on a scale 1-10. 1 is normal skin. 10 is worst scar imaginable.
Modified Patient and Observer Scar Assessment Scale v2.0 (POSAS)
Time frame: 4-8 weeks following surgery
Two blinded dermatologists will make the objective clinical assessments separately using a modified POSAS Patient and Observer Scar Assessment Scale v2.0 It includes assessing the vascularity, pigmentation, thickness, relief, and surface area from a scale from 1 to 10. Pliability, which is included in the original scale, will be excluded for this study given the use of photographs for assessment. The scale also includes the patient's opinion of their own scar, which includes pain, pruritis, color, stiffness, thickness, irregularity from a scale from 1 to 10.Independent objective review of scar photos will be graded on a scale 1-10. 1 is normal skin. 10 is worst scar imaginable. These scores will be compared to the 1 week time point.
Modified Patient and Observer Scar Assessment Scale v2.0 (POSAS)
Time frame: 6 month mark following surgery
Two blinded dermatologists will make the objective clinical assessments separately using a modified POSAS Patient and Observer Scar Assessment Scale v2.0 It includes assessing the vascularity, pigmentation, thickness, relief, and surface area from a scale from 1 to 10. Pliability, which is included in the original scale, will be excluded for this study given the use of photographs for assessment. The scale also includes the patient's opinion of their own scar, which includes pain, pruritis, color, stiffness, thickness, irregularity from a scale from 1 to 10.Independent objective review of scar photos will be graded on a scale 1-10. 1 is normal skin. 10 is worst scar imaginable. These scores will be compared to the 1 week and the 4-8 weeks time point.
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 15 Jun 2025.
- Results publication: PubMed 22090252Singh KA, Losken A. Additional benefits of reduction mammaplasty: a systematic review of the literature. Plast Reconstr Surg. 2012 Mar;129(3):562-570. doi: 10.1097/PRS.0b013e31824129ee.
- Results publication: PubMed 19341651Sprole AM, Adepoju I, Ascherman J, Gayle LB, Grant RT, Talmor M. Horizontal or vertical? an evaluation of patient preferences for reduction mammaplasty scars. Aesthet Surg J. 2007 May-Jun;27(3):257-62. doi: 10.1016/j.asj.2007.04.007.
- Results publication: PubMed 24501476Saleem L, John JR. Unfavourable results following reduction mammoplasty. Indian J Plast Surg. 2013 May;46(2):401-7. doi: 10.4103/0970-0358.118620.
- Results publication: PubMed 10077078Hidalgo DA. Improving safety and aesthetic results in inverted T scar breast reduction. Plast Reconstr Surg. 1999 Mar;103(3):874-86; discussion 887-9.
- Results publication: PubMed 19215252Wolfram D, Tzankov A, Pulzl P, Piza-Katzer H. Hypertrophic scars and keloids--a review of their pathophysiology, risk factors, and therapeutic management. Dermatol Surg. 2009 Feb;35(2):171-81. doi: 10.1111/j.1524-4725.2008.34406.x.
- Results publication: PubMed 11348456Niland S, Cremer A, Fluck J, Eble JA, Krieg T, Sollberg S. Contraction-dependent apoptosis of normal dermal fibroblasts. J Invest Dermatol. 2001 May;116(5):686-92. doi: 10.1046/j.1523-1747.2001.01342.x.
- Results publication: PubMed 18843115Chen CS. Mechanotransduction - a field pulling together? J Cell Sci. 2008 Oct 15;121(Pt 20):3285-92. doi: 10.1242/jcs.023507.
- Results publication: PubMed 12845617Gabbiani G. The myofibroblast in wound healing and fibrocontractive diseases. J Pathol. 2003 Jul;200(4):500-3. doi: 10.1002/path.1427.
- Results publication: PubMed 18555763Zhibo X, Miaobo Z. Botulinum toxin type A affects cell cycle distribution of fibroblasts derived from hypertrophic scar. J Plast Reconstr Aesthet Surg. 2008 Sep;61(9):1128-9. doi: 10.1016/j.bjps.2008.05.003. Epub 2008 Jun 13. No abstract available.
- Results publication: PubMed 18534768Zhibo X, Miaobo Z. Potential therapeutical effects of botulinum toxin type A in keloid management. Med Hypotheses. 2008 Oct;71(4):623. doi: 10.1016/j.mehy.2008.04.018. Epub 2008 Jun 4. No abstract available.
- Results publication: PubMed 19802513Xiao Z, Zhang F, Lin W, Zhang M, Liu Y. Effect of botulinum toxin type A on transforming growth factor beta1 in fibroblasts derived from hypertrophic scar: a preliminary report. Aesthetic Plast Surg. 2010 Aug;34(4):424-7. doi: 10.1007/s00266-009-9423-z. Epub 2009 Oct 3.
- Results publication: PubMed 28654594Chen HC, Yen CI, Yang SY, Chang CJ, Yang JY, Chang SY, Chuang SS, Hsiao YC. Comparison of Steroid and Botulinum Toxin Type A Monotherapy with Combination Therapy for Treating Human Hypertrophic Scars in an Animal Model. Plast Reconstr Surg. 2017 Jul;140(1):43e-49e. doi: 10.1097/PRS.0000000000003426.
- Individual participant dataSharing planned: No. There will be a publication based on the results of the study. We will not be sharing individual participant data outside of our facility. All data will be kept on the secure drive at Henry Ford Health Systems.
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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.
David Ozog, MD principal investigator
Henry Ford Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Botulinum Toxins and Normal saline in people with Scar and Hypertrophic Scar, run by Henry Ford Health System 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 5 inclusion and 13 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 15 Jun 2025. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 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?
Modified Patient and Observer Scar Assessment Scale v2.0 (POSAS) (time frame: Photos will be reviewed at the 1 week follow surgery). The study lists 3 primary outcomes in all. 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 NCT03887377, which also lists 21 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 15 Jun 2025.