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NCT Number: NCT04523506

The Effects of Botulinum Toxin on Oral Aperture in Patients With Scleroderma

This study will evaluate the use of botulinum toxin for microstomia (also known as reduced oral aperture) in scleroderma patients. Botox is a neurotoxin that functions as a paralytic by preventing the release of acetylcholine to inhibit muscle contracture and decrease fibrosis by decreasing differentiation of fibroblasts to myofibroblasts, decreasing expression of collagen, and increasing expression of matrix metalloproteinase1-3. The study will include three arms: the temporomandibular joint (TMJ) group who will receive injections of Botox to the masseter, the perioral group who will receive injections of Botox around the lips, and a control group who will receive no treatment for ROA. Outcome measurements will include measurement of oral aperture size through measurement inter-labial distance and between the upper and lower lips and the inter-incisal distance, patient satisfaction via a Skindex16 survey, mouth disability via the Mouth Handicap in Systemic Sclerosis Scale (MHISS), and patient and physician satisfaction using the Visual Analogic Scale (VAS). The maximum number of subjects to be consented for this study is 30. The study is expected to last four months per subject from time of consent to last clinical evaluation. Conditions that may result in a subject exiting the study prior to completion date include non-compliance, withdrawal of consent, or safety concerns such as adverse events as a result of treatment.

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Key information

Conditions

Scleroderma Connective Tissue Diseases Scleroderma, Diffuse Scleroderma, Systemic Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

UT Southwestern Medical Center at Dallas - Dermatology Clinical Trials

Dallas, Texas, 75390-8802, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ddiagnosis of scleroderma (defined by the 2013 Classification Criteria for Systemic Sclerosis4,5)23,24 ) who also have microstomia (reduced oral aperture), defined as an inter-incisal distance less than 50 mm 6-7)m13,14 .
  • Male and female subjects.
  • English and non-English speakers.
  • Subjects aged 18 years old to 65 years old will be considered

Exclusion criteria

  • Patients under 18 years old will be excluded.
  • Patients with a known history of a hypersensitivity to any Botox formulation or to any of the components in the formulation,
  • Active skin infection at the proposed injection site.
  • Concomitant neuromuscular disorder.
  • Pregnant or lactating.
  • Missing incisors.
  • treatment with: cyclophosphamide, Ultraviolet A-1 therapy, or topical calcitriol..

Treatment and study plan

Botulinum toxin(Botox)

Biological

This study will evaluate the use of botulinum toxin for reduced oral aperture in scleroderma patients. Botox is a neurotoxin that functions as a paralytic by preventing the release of acetylcholine to inhibit muscle contracture and decrease fibrosis by decreasing differentiation of fibroblasts to myofibroblasts, decreasing expression of collagen, and increasing expression of matrix metalloproteinase.

Primary outcomes

  1. Changes in inter-labial distance

    Time frame: This will be measured at baseline before treatment, 2 weeks after treatment, and 3 months after treatment.

    Inter-labial distance is defined as the distance between the upper and lower lip at maximum mouth opening. Distance will be measured using digital calipers by the same operator

  2. Changes interincisal distance

    Time frame: This will be measured at baseline before treatment, 2 weeks after treatment, and 3 months after treatment.

    Interincisal distance is defined by the didistance between upper and lower incisor at maximum mouth opening. Distance will be measured using digital calipers by the same operator

  3. quality of life via a Skindex16 survey

    Time frame: This information will be collected at baseline before treatment, 2 weeks after treatment, and 3 months after treatment.

    This is a patient quality of life survey using the skindex 16 survey form.

Secondary outcomes

  1. Changes in the inter-commissural distance

    Time frame: This will be measured at baseline before treatment, 2 weeks after treatment, and 3 months after treatment.]

    Inter-commissural distance is defined by the distance from corner to corner at the angle of the lip (also known as the oral commissures). Distance will be measured using digital calipers by the same operator.

  2. Changes in the Mouth Handicap in Systemic Sclerosis Scale (MHISS)

    Time frame: This will be measured at baseline before treatment, 2 weeks after treatment, and 3 months after treatment.]

    Mouth disability will be assessed via the Mouth Handicap in Systemic Sclerosis Scale (MHISS). MHISS range from 0 to 48 with 48 being worse disability

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 21, 2020
Registry last updated
Apr 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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