NCT04593706

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 20, 2020

Completed
12 days until next milestone

Study Start

First participant enrolled

November 1, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2021

Completed
Last Updated

October 20, 2020

Status Verified

August 1, 2020

Enrollment Period

12 months

First QC Date

July 29, 2020

Last Update Submit

October 18, 2020

Conditions

KeloidHypertrophic ScarScarsScarring

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (7)

  • Visual analogue scale (pain scale)

    at each of the three treatment appointments, data will be reported through study completion an average of 1 year

  • Dermatologist's assessment

    3 months post last treatment, data will be reported through study completion an average of 1 year

  • 3D camera

    3 months post last treatment, data will be reported through study completion an average of 1 year

  • Participant's assessment

    3 months post last treatment, data will be reported through study completion an average of 1 year

  • Dermatologist's assessment

    6 months post last treatment, data will be reported through study completion an average of 1 year

  • +2 more secondary outcomes

Study Arms (2)

keloids

ACTIVE COMPARATOR

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 phosphateDrug: Dexamethasone sodium phosphateDrug: Methylprednisolone acetateDrug: Triamcinolone acetonide

hypertrophic scars

ACTIVE COMPARATOR

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 phosphateDrug: Dexamethasone sodium phosphateDrug: Methylprednisolone acetateDrug: Triamcinolone acetonide

Interventions

Betamethasone acetate + Betamethasone sodium phosphateDRUG

the steroid will be injected to either a keloid or a 1.5 c"m of the 11 c"m hypertrophic scar

hypertrophic scarskeloids
Dexamethasone sodium phosphateDRUG

the steroid will be injected to either a keloid or a 1.5 c"m of the 11 c"m hypertrophic scar

hypertrophic scarskeloids
Methylprednisolone acetateDRUG

the steroid will be injected to either a keloid or a 1.5 c"m of the 11 c"m hypertrophic scar

hypertrophic scarskeloids
Triamcinolone acetonideDRUG

the steroid will be injected to either a keloid or a 1.5 c"m of the 11 c"m hypertrophic scar

hypertrophic scarskeloids

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • participants with at least 4 keloids
  • participants with a hypertrophic scar of at least 11 cm length

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

KeloidCicatrix, HypertrophicCicatrix

Interventions

betamethasone acetatebetamethasone sodium phosphatedexamethasone 21-phosphateMethylprednisolone AcetateTriamcinolone Acetonide

Condition Hierarchy (Ancestors)

Collagen DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MethylprednisolonePrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsTriamcinoloneSteroids, Fluorinated

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2020

First Posted

October 20, 2020

Study Start

November 1, 2020

Primary Completion

October 31, 2021

Study Completion

October 31, 2021

Last Updated

October 20, 2020

Record last verified: 2020-08