Keloid Clinical Trial
Official title:
Comparison of the Efficacy of Different Steroids in the Treatment of Abnormal Scars (Keloids, Hypertrophic Scars)
Verified date | August 2020 |
Source | Tel-Aviv Sourasky Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Comparison of the Efficacy of Different Steroids in the Treatment of Abnormal Scars (Keloids and hypertrophic Scars)
Status | Not yet recruiting |
Enrollment | 40 |
Est. completion date | October 31, 2021 |
Est. primary completion date | October 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 20 participants with at least 4 keloids - 20 participants with a hypertrophic scar of at least 11 cm length Exclusion Criteria: - current or planned pregnancy - breastfeeding women - participants suffering from diabetes mellitus or coagulation disorders - infection at planned injection sites - systemic treatment of corticosteroids, 5-fluorouracil - known allergy to any of the following: Betamethasone acetate + Betamethasone sodium phosphate, Triamcinolone acetonide, Dexamethasone sodium phosphate, Methylprednisolone acetate |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Tel-Aviv Sourasky Medical Center |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient and Observer Scar Assessment Scale (POSAS) | For the Observer Scar Assessment Scale (OSAS), the investigators score the following parameters of each part of the scar on a scale ranging from 1 (normal skin) to 10 (worst scar imagin¬able): 'vascularization', 'pigmentation', 'thickness', 'relief', and 'pliability'. The total score on the OSAS is the sum of the scores of each item, yielding a total score ranging from 6 (best) to 60 (worst). For the patient scar assessment scale (PSAS), the participants used a scale of 1 to 10 to answer questions relating to pain, itching, color, stiffness, irregularity and thickness. The total score on the PSAS was the sum of the scores of each item, yielding a total score ranging from 6 (best) to 60 (worst) | enrollment, data will be reported through study completion an average of 1 year | |
Primary | Patient and Observer Scar Assessment Scale (POSAS) | For the Observer Scar Assessment Scale (OSAS), the investigators score the following parameters of each part of the scar on a scale ranging from 1 (normal skin) to 10 (worst scar imagin¬able): 'vascularization', 'pigmentation', 'thickness', 'relief', and 'pliability'. The total score on the OSAS is the sum of the scores of each item, yielding a total score ranging from 6 (best) to 60 (worst). For the patient scar assessment scale (PSAS), the participants used a scale of 1 to 10 to answer questions relating to pain, itching, color, stiffness, irregularity and thickness. The total score on the PSAS was the sum of the scores of each item, yielding a total score ranging from 6 (best) to 60 (worst) | 3 months post last treatment, data will be reported through study completion an average of 1 year | |
Primary | Patient and Observer Scar Assessment Scale (POSAS) | For the Observer Scar Assessment Scale (OSAS), the investigators score the following parameters of each part of the scar on a scale ranging from 1 (normal skin) to 10 (worst scar imagin¬able): 'vascularization', 'pigmentation', 'thickness', 'relief', and 'pliability'. The total score on the OSAS is the sum of the scores of each item, yielding a total score ranging from 6 (best) to 60 (worst). For the patient scar assessment scale (PSAS), the participants used a scale of 1 to 10 to answer questions relating to pain, itching, color, stiffness, irregularity and thickness. The total score on the PSAS was the sum of the scores of each item, yielding a total score ranging from 6 (best) to 60 (worst) | 6 months post last treatment, data will be reported through study completion an average of 1 year | |
Secondary | Visual analogue scale (pain scale) | 1 - paineless, 10- extremely painfull | at each of the three treatment appointments, data will be reported through study completion an average of 1 year | |
Secondary | Dermatologist's assessment | 0- no change, 1-minor change <5%, 2-Mild change - 25-50%, 3- Moderate Change 50-75%, 4-Significant change > 75% | 3 months post last treatment, data will be reported through study completion an average of 1 year | |
Secondary | 3D camera | improvement percentage of scar volume | 3 months post last treatment, data will be reported through study completion an average of 1 year | |
Secondary | Participant's assessment | 0- no change, 1-minor change <5%, 2-Mild change - 25-50%, 3- Moderate Change 50-75%, 4-Significant change > 75% | 3 months post last treatment, data will be reported through study completion an average of 1 year | |
Secondary | Dermatologist's assessment | 0- no change, 1-minor change <5%, 2-Mild change - 25-50%, 3- Moderate Change 50-75%, 4-Significant change > 75% | 6 months post last treatment, data will be reported through study completion an average of 1 year | |
Secondary | 3D camera | improvement percentage of scar volume | 6 months post last treatment, data will be reported through study completion an average of 1 year | |
Secondary | Participant's assessment | 0- no change, 1-minor change <5%, 2-Mild change - 25-50%, 3- Moderate Change 50-75%, 4-Significant change > 75% | 6 months post last treatment, data will be reported through study completion an average of 1 year |
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