An interventional study of Betamethasone acetate + Betamethasone sodium phosphate and Dexamethasone sodium phosphate in Keloid, Hypertrophic Scar and Scars, sponsored by Tel-Aviv Sourasky Medical Center. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-10-20.
Sponsored by Tel-Aviv Sourasky Medical Center · Not applicable, Interventional, and Treatment
Comparison of the Efficacy of Different Steroids in the Treatment of Abnormal Scars (Keloids and hypertrophic Scars)
On a yearly basis, millions develop different skin scarring. These scars are a public reminder of the traumatic incident, past or present disease or a surgery which caused them.
Scarring is a common consequence of wound healing process, and it is one of the most complex biological processes in human. This healing process is affected by numerous factors and thus can be disrupted, leading to pathological scarring.
Pathological scarring is common in people with genetic predisposition, those undergone complex and massive surgeries, burns or those wounded in unsanitary environments. Apart from being aesthetically unpleasant, scars are associated with functional and psychosocial morbidities.
Despite clinical, pathologic and pathogenic differences between keloids and hypertrophic scars, treatments are similar.
Scars have a negative external impact causing social distress and impaired self-image, and as a consequence, low satisfaction rates following surgical and cosmetic procedures.
The first line treatment is monthly intralesional corticosteroid injections with a response rate of 50-100% and recurrence of 50%.
There are a few steroids available and used for abnormal scars treatment, including Celestone chronodose (Betamethasone acetate + Betamethasone sodium phosphate), Dexamethasone sodium phosphate, Methylprednisolone acetate, Methylprednisolone sodium succinate, Methylprednisolone hemisuccinate, Triamcinolone acetonide.
Steroids are different by their hydrophilic properties, potency and half-life, although the half-life of intralesional injections is not known. Inspite of being widely used, there have never been a comparative study of the different steroid treatments.
123 studies on the registry are indexed under Keloid; 23 are open to participants now.
This study's planned enrollment of 40 is above the median of 30 across 97 interventional studies indexed under Keloid.
Browse Keloid studies →Tel-Aviv Sourasky Medical Center is the lead sponsor of 541 studies on the registry; 49 are open to participants now.
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Exclusion Criteria:
each patient will be injection by all 4 steroids for comparison patients with 4 or more keloids will be injection with each steroid for different keloid
Drug: Betamethasone acetate + Betamethasone sodium phosphate · Drug: Dexamethasone sodium phosphate · Drug: Methylprednisolone acetate · Drug: Triamcinolone acetonide
each patient will be injection by all 4 steroids for comparison patients with a 11 cm hypertrophic scar will be injected by all 4 steroids along the scar with a 1 cm distance between each steroid
Drug: Betamethasone acetate + Betamethasone sodium phosphate · Drug: Dexamethasone sodium phosphate · Drug: Methylprednisolone acetate · Drug: Triamcinolone acetonide
the steroid will be injected to either a keloid or a 1.5 c"m of the 11 c"m hypertrophic scar
the steroid will be injected to either a keloid or a 1.5 c"m of the 11 c"m hypertrophic scar
the steroid will be injected to either a keloid or a 1.5 c"m of the 11 c"m hypertrophic scar
the steroid will be injected to either a keloid or a 1.5 c"m of the 11 c"m hypertrophic scar
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)
Time frame: enrollment, data will be reported through study completion an average of 1 year
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)
Time frame: 3 months post last treatment, data will be reported through study completion an average of 1 year
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)
Time frame: 6 months post last treatment, data will be reported through study completion an average of 1 year
Visual analogue scale (pain scale)
1 - paineless, 10- extremely painfull
Time frame: at each of the three treatment appointments, data will be reported through study completion an average of 1 year
Dermatologist's assessment
0- no change, 1-minor change \<5%, 2-Mild change - 25-50%, 3- Moderate Change 50-75%, 4-Significant change \> 75%
Time frame: 3 months post last treatment, data will be reported through study completion an average of 1 year
3D camera
improvement percentage of scar volume
Time frame: 3 months post last treatment, data will be reported through study completion an average of 1 year
Participant's assessment
0- no change, 1-minor change \<5%, 2-Mild change - 25-50%, 3- Moderate Change 50-75%, 4-Significant change \> 75%
Time frame: 3 months post last treatment, data will be reported through study completion an average of 1 year
Dermatologist's assessment
0- no change, 1-minor change \<5%, 2-Mild change - 25-50%, 3- Moderate Change 50-75%, 4-Significant change \> 75%
Time frame: 6 months post last treatment, data will be reported through study completion an average of 1 year
3D camera
improvement percentage of scar volume
Time frame: 6 months post last treatment, data will be reported through study completion an average of 1 year
Participant's assessment
0- no change, 1-minor change \<5%, 2-Mild change - 25-50%, 3- Moderate Change 50-75%, 4-Significant change \> 75%
Time frame: 6 months post last treatment, data will be reported through study completion an average of 1 year
No study locations are listed for this record.
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Tel-Aviv Sourasky Medical Center