Comparison of the Efficacy of Different Steroids in the Treatment of Abnormal Scars (Keloids, Hypertrophic Scars)

Keloid Clinical Trial

Official title:

Comparison of the Efficacy of Different Steroids in the Treatment of Abnormal Scars (Keloids, Hypertrophic Scars)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04593706
• Other study ID #: 0542-19-TLV
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: October 31, 2021

Study information

• Verified date: August 2020
• Source: Tel-Aviv Sourasky Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Comparison of the Efficacy of Different Steroids in the Treatment of Abnormal Scars (Keloids and hypertrophic Scars)

Description:

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Cicatrix
• Cicatrix, Hypertrophic
• Hypertrophic Scar
• Hypertrophy
• Keloid
• Scarring
• Scars

Intervention

Drug:
• Betamethasone acetate + Betamethasone sodium phosphate
the steroid will be injected to either a keloid or a 1.5 c"m of the 11 c"m hypertrophic scar
• Dexamethasone sodium phosphate
the steroid will be injected to either a keloid or a 1.5 c"m of the 11 c"m hypertrophic scar
• Methylprednisolone acetate
the steroid will be injected to either a keloid or a 1.5 c"m of the 11 c"m hypertrophic scar
• Triamcinolone acetonide
the steroid will be injected to either a keloid or a 1.5 c"m of the 11 c"m hypertrophic scar

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Outcome

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