Keloid Clinical Trial
Official title:
A Prospective, Randomized, Investigator-blinded, Placebo-controlled, Comparative Study Evaluating the Tolerability and Efficacy of Two Topical Therapies for the Treatment of Keloids and Hypertrophic Scars
Keloids are thought to result from derailments in the typical wound healing process following
cutaneous injury. Current treatment options for keloids include intralesional
corticosteroids, silicone gel sheeting, compression, surgery and adjuvants to surgery,
including radiation and cryotherapy.
0.5% hydrocortisone, silicone, vitamin E lotion (HSE) and onion extract gel (OE) are widely
used over-the-counter medications for the treatment of keloids and hypertrophic scars.
However, their efficacy and safety have not been compared in a blinded, placebo-controlled,
prospective fashion. This study is being undertaken to determine the efficacy and safety of
HSE versus OE versus placebo (Cetearyl alcohol; CEA) in subjects with hypertrophic scars and
keloids.
This is an investigator-blinded study, which means that the doctor evaluating you will not
know if you are receiving the study medication or not. Another doctor will be supplying you
with the medication and discussing any problems that you may have with the medication.
You will be assigned to one of the three treatment groups: HSE, OE, or CEA. The group will be
assigned by chance and you will have two in three chances of receiving treatment with a study
medication, HSE or OE. The no treatment group will receive CEA, a bland lotion, containing no
active ingredients such as steroids, silicone, vitamin E, or onion extract.
This study will last up to 16 weeks, with a total of 5 visits to the clinic (Baseline visit,
Week 4, 8, 12, and 16 ), excluding the Screening Visit.
Screening Visit/Baseline Visit:
Patients will read and be explained the informed consent. Patients who agree to participate
will sign the informed consent and a copy will be given to them. Medical history and
exclusion/inclusion criteria will be reviewed; if a patient qualifies he/she will be assigned
a randomization number for the treatment.
At the baseline visit, medical history and exclusion/inclusion criteria since the screening
visit will be reviewed. Patients randomized to the HSE group will receive one tube and apply
the first application to the keloid/hypertrophic scar during the baseline visit. Patients
randomized to the OE group will be given a tube of OE gel and will apply the first
application to the keloid/hypertrophic scar. Patients in the placebo group will be given a
bottle of CEA lotion, the placebo medication, and will apply the first application to the
keloid/hypertrophic scar. The medications will be given by the unblinded investigator and the
blinded investigator will be evaluating the patients. Photographs of the patient's
keloid/hypertrophic scar will be taken, and the keloid/hypertrophic scar will be
measured/assessed according to Methods of Study Lesion Assessment (below). A urine pregnancy
test will be obtained for all women of child-bearing potential.
Week 4, 8, 12, and 16 Visit:
Patients will be asked about side effects since last visit. Photographs of the patient's
keloid/hypertrophic scar will be taken and the keloid/hypertrophic scar will be
measured/assessed according to Methods of Study Lesion Assessment (below). A urine pregnancy
test will be obtained at for all women of child-bearing potential.
Methods of Study Lesion Assessment
A. Volume B. Linear dimensions
Investigator's Assessments w/ Visual Analog Scale (VAS):
C. Cosmetic assessment D. Induration (hardness) [compared to standardized hard discs with
numerical ranking of increased induration] E. Erythema (redness) F. Pigmentary alteration
Patient's Assessments w/ VAS:
G. Cosmetic assessment H. Pain I. Tenderness J. Pruritus (itching) K. Patient satisfaction
L. Digital photographs
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT02923596 -
Retrospective Study of Keloid Disorder
|
N/A | |
Completed |
NCT02922972 -
Treatment of Keloid Scar by Autologous Platelet Rich Plasma Obtained With RgenKit-BCT
|
N/A | |
Terminated |
NCT01478243 -
Study of Psycho-Social Impact of Keloid
|
N/A | |
Recruiting |
NCT01423383 -
Epidemiology Study of Keloid
|
N/A | |
Completed |
NCT03228693 -
Gene Expression and Biomarker Profiling of Keloid Skin
|
N/A | |
Not yet recruiting |
NCT04326959 -
Implantation of Mesenchymal Stem Cell, Conditioned Medium, or Triamcinolone Acetonide for Keloid
|
Phase 1/Phase 2 | |
Recruiting |
NCT03312166 -
Compressive Device to Prevent Keloïd Scars Recurrence [SCARWARS]
|
N/A | |
Recruiting |
NCT02823236 -
Efficacy of Intralesional Triamcinolone and 8% Topical Pirfenidone for Treatment of Keloid Scars
|
Phase 3 | |
Recruiting |
NCT04597060 -
The Safety and Efficacy of Thermo-mechanical System for Fractional Ablation Associated Triamcinolone Acetonide Drug Delivery for the Treatment of Hypertrophic Scars and Keloids
|
N/A | |
Completed |
NCT05939817 -
The Effect of Intralesian Injection of Umbilical Cord Mesenchymal Stem Cells, Its Conditioned Medium, and Triamcinolone Acetonide on Type 1:3 Collagen Ratio and Interleukin-10 Levels in Keloid: A Randomised Controlled Trial
|
Phase 4 | |
Completed |
NCT05887804 -
Comparison of Keloid Volume and Symptoms Reduction Between Intralesional Umbilical-Cord Mesenchymal Stem Cells, Its Conditioned Medium, and Triamcinolone Acetonide Injection as Keloid Therapy: A Randomised Controlled Trial
|
Phase 4 | |
Completed |
NCT03630198 -
Pain Outcomes Following Intralesional Corticosteroid Injections
|
Phase 4 | |
Completed |
NCT04169438 -
Pilot Study Investigating a Restorative Wound Care Cream Together With Petrolatum on Surgical Excisions
|
N/A | |
Recruiting |
NCT01423981 -
Web Based Investigation of Natural History of Keloid Disorder, an Online Survey
|
N/A | |
Completed |
NCT01446770 -
Evaluation of the Initial Safety and Efficacy of Keloid Lesions Treated With MF-4181
|
Phase 2 | |
Recruiting |
NCT06138964 -
Comparing the Effect of siSPARC Microneedle Patch Versus siSPARC+siLR4A Microneedle Patch on Post-surgical Scars
|
Phase 3 | |
Enrolling by invitation |
NCT05461157 -
Preoperative Silicone Ointment and Wound Healing
|
N/A | |
Not yet recruiting |
NCT04593706 -
Comparison of the Efficacy of Different Steroids in the Treatment of Abnormal Scars (Keloids, Hypertrophic Scars)
|
N/A | |
Active, not recruiting |
NCT04988022 -
Dupilumab in the Treatment of Keloids
|
Phase 4 | |
Withdrawn |
NCT02546076 -
Comparison of Dual-mode ER:YAG Laser in Patients With Long Keloid/Hypertrophic Scars
|
Phase 2 |