['systemic scleroderma']
['c-82 topical gel, 1%', 'c-82 topical gel, placebo']

        Inclusion Criteria:

          -  meet the American College of Rheumatology criteria for systemic sclerosis with diffuse
             cutaneous involvement (clinical skin involvement proximal to forearms and or knees,
             not including the face).

          -  Disease duration of <36 months since the onset of the first SSc manifestation other
             than Raynaud's phenomenon, or patients with progressive disease based on new or
             worsening skin disease based on physician assessment.

          -  local skin score over the bilateral forearm of ≥ 2.

          -  a MRSS of ≥ 12.

          -  on stable dose of any immunosuppressive other than cyclophosphamide or high dose
             steroids (excluded treatments) for at least one month and through the course of study
             treatment.

          -  Subjects of child-producing potential must agree to use effective contraception while
             and for at least 3 months after the last treatment.

        Exclusion Criteria:

          -  Receiving treatment as part of an interventional clinical trial within 4 weeks of
             screening or 5 half-lives of the investigational drug (whichever is longer).

          -  Ongoing use of high dose steroids (> 10mg/day prednisone or equivalent) or unstable
             steroid dose in the past 4 weeks.

          -  Use of topical creams or gels on the forearm area within the past month and through
             the course of study treatment.

          -  UV light therapy for 4 weeks before or during the study period.

          -  Treatment with cyclophosphamide within the past month and through the course of study
             treatment.

          -  Known active bacterial, viral fungal mycobacterial, or other infection

          -  history of malignancy within the past 2 years.

          -  Moderate to severe hepatic impairment, .

          -  Scleroderma renal crisis within 4 months or creatinine greater than 2.0.

          -  Pregnancy.

          -  Nursing mothers are to be excluded.

          -  Gastrointestinal involvement requiring total parenteral nutrition or hospitalization
             within the past 3 months for pseudo-obstruction

          -  Moderately severe pulmonary disease with FVC < 40%, or DLCO < 30% predicted or
             evidence of progressive lung disease as manifest by a decrease in FVC or 10% or more
             over the previous year.

          -  Moderately severe cardiac disease with clinically significant heart failure, or
             unstable angina.

          -  AST or ALT > 2.5 x Upper Limit of Normal.

          -  Total bilirubin > 1.5 x upper limit of normal (ULN). Patients with Gilbert's Disease
             may be included if their total bilirubin is ≤ 3.0 mg/dL.

          -  significant medical or psychosocial problems that warrant exclusion.
      