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

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

Study Overview

• Status: Unknown
• Conditions: Scars; Keloid; Hypertrophic Scar; Scarring
• Intervention / Treatment: Drug: Betamethasone acetate + Betamethasone sodium phosphate; Drug: Dexamethasone sodium phosphate; Drug: Methylprednisolone acetate; Drug: Triamcinolone acetonide

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: keloids; 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; the steroid will be injected to either a keloid or a 1.5 c"m of the 11 c"m hypertrophic scar; Drug: 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; Drug: Methylprednisolone acetate; the steroid will be injected to either a keloid or a 1.5 c"m of the 11 c"m hypertrophic scar; 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
Active Comparator: hypertrophic scars; 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; the steroid will be injected to either a keloid or a 1.5 c"m of the 11 c"m hypertrophic scar; Drug: 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; Drug: Methylprednisolone acetate; the steroid will be injected to either a keloid or a 1.5 c"m of the 11 c"m hypertrophic scar; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
3D camera	improvement percentage of scar volume	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%	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%	6 months post last treatment, data will be reported through study completion an average of 1 year
3D camera	improvement percentage of scar volume	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%	6 months post last treatment, data will be reported through study completion an average of 1 year

Collaborators and Investigators

• Sponsor: Tel-Aviv Sourasky Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2020
• Primary Completion (Anticipated): October 31, 2021
• Study Completion (Anticipated): October 31, 2021

Study Registration Dates

• First Submitted: July 29, 2020
• First Submitted That Met QC Criteria: October 18, 2020
• First Posted (Actual): October 20, 2020

Study Record Updates

• Last Update Posted (Actual): October 20, 2020
• Last Update Submitted That Met QC Criteria: October 18, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Connective Tissue Diseases; Pathological Conditions, Anatomical; Fibrosis; Collagen Diseases; Hypertrophy; Cicatrix; Keloid; Cicatrix, Hypertrophic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protease Inhibitors; Neuroprotective Agents; Protective Agents; Anti-Asthmatic Agents; Respiratory System Agents; Dexamethasone; Dexamethasone acetate; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; BB 1101; Betamethasone; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Betamethasone benzoate; Betamethasone sodium phosphate; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate; Dexamethasone 21-phosphate; Betamethasone acetate
• Other Study ID Numbers: 0542-19-TLV

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No