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Not yet recruitingNCT07898605Updated Oct 27, 2026

Fractional Radiofrequency With Streroids Versus Fractional CO2 Laser With Steroids in the Treatment of Keloids

An interventional study of fractional microneedle radiofrequency and fractional co2 laser in Keloids, sponsored by Cairo University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

Updated Oct 27, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Keloids are harmless, raised scars that develop when the body produces too much scar tissue after an injury, surgery, or other skin damage. They may grow beyond the original wound, become firm, red or purple, and cause itching. Treatment options include silicone dressings, pressure therapy, steroid injections, surgery, freezing, laser therapy, radiation, and other medicines. Steroid injections, especially triamcinolone, can soften and reduce the size and thickness of keloids. Radiofrequency microneedling is another treatment that uses very fine needles and controlled energy to create tiny channels in the skin. This may reduce keloid tissue, encourage healthier healing, and help steroid medication reach deeper into the scar

Read the detailed description

Keloids are an abnormal proliferation of scar tissue that forms at the site of cutaneous injury (e.g., on the site of a surgical incision or trauma); it does not regress with time, but it tends to grow beyond the original margins of the scar. They are benign dermal fibroproliferative tumors with no malignant potential. It results from excessive proliferation of normal tissue at healing processes with loss of the control mechanisms that normally regulate the fine balance of tissue repair and regeneration. The collagen fibrils in keloids are more irregular, abnormally thick, and have unidirectional fibers arranged in a highly stressed orientation. They are initially manifest as erythematous papules, plaques or nodules devoid of hair follicles and other normal glandular tissue. They are usually purplish-red in color, firm, smooth, raised and itchy. The consistency can range from soft, doughy, rubbery and hard. Most keloids tend to grow slowly over months to a year, extending past the initial area of injury. Treatments for keloids includes; occlusive dressings, compression, intralesional steroid injections, excisional surgery, radiation, cryosurgery Laser therapy, interferon therapy, 5-fluorouracil injected intralesionally and imiquimod therapy.

Corticosteroids contribute by many mechanisms in treatment of keloids. They inhibit leukocyte functions causing tissue hypoxia. They also inhibit cellular proliferation, decreasing collagen deposition and increase collagenase that breaks down collagen fibers. They were used both topically and intralesionally, with triamcinolone acetate being the most common used type. Triamcinolone acetate treatment significantly reduce the size of keloid compared to untreated control. Reduction in size was statistically different in favor ofTriamcinolone acetonide compared to silicone gel sheet, it also showed improvement in vascularity and scar pliability and reduced scar thickness. Trans epidermal drug delivery is a novel method of drug delivery in dermatology, through the formation of micro-channels in the epidermis to increase the delivery of various substances into the skin. Many devices have been used for this method of drug delivery including microneedling devices(dermapen,dermaroller), fractional co2 laser, radiofrequency devices (RF). Radiofrequency microneedling is a well-studied, energy-based method delivering radiofrequency at \~1-2 MHz via insulated or non-insulated needles. They are fine needles that create controlled micro-injuries in the epidermis and dermis, these microchannels trigger a wound-healing cascade, stimulating collagen and elastin production.

Insulated radiofrequency microneedling delivers a focused, local injury to the dermis, sparing epidermal injury that can cause undesirable erythema, changes in pigmentation, and scarring that is often seen with laser treatments and traditional microneedling.

Radiofrequency has been used as a way of trans epidermal of drugs as in delivery of retinoic acid for treatment of atrophic scars and stretch marks, Triamcinolone acetonide for treatment of hypertrophic scars.

Radiofrequency has been used in the treatment of keloids, as it causes keloidal tissue volume reduction by inducing controlled protein denaturation or necrosis in soft tissue structures using very low levels of radiofrequency energy, then wound healing will take its normal process with scar formation and retraction of tissue, resulting in an overall reduction of volume in the treated area. The newly formed scar tissue is partially resorbed by the body over time, causing further volume reduction. It has been used in combination with steroids in treating keloids .

02

Conditions studied

  • Keloids

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03

In context

Keloid

125 studies on the registry are indexed under Keloid; 24 are open to participants now.

This study's planned enrollment of 20 is below the median of 30 across 99 interventional studies indexed under Keloid.

Browse Keloid studies →

Lead sponsor

Cairo University is the lead sponsor of 4,911 studies on the registry; 1,443 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patients with one or more keloids (extends beyond the original wound margins). 2. All skin types 3. Both genders 4. Willingness and ability to comply with the requirements 5. Age above 18 years old 6. Keloids present for at least 6 months

Exclusion criteria

Exclusion Criteria:

  1. Topical or intralesional steroid treatment for keloid in the last 3 months
  2. Lidocaine sensitivity
  3. Pregnancy and lactation
  4. Severe systemic illness or malignancy
  5. Bacterial infections, other infections such as HBV, HCV or HIV.
  6. Age below 18 years.
  7. Ear Keloids
  8. Patients who are currently on oral isotretinoin or systemic steroid drugs.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
20 participants (estimated)

Study arms

  • Active comparator
    group A

    Keloid lesion receiving fractional radiofrequency and topical triamcinolone

    Device: fractional microneedle radiofrequency

  • Active comparator
    group B

    Keloid lesion receiving fractional carbon dioxide laser and topical triamcinolone

    Device: fractional co2 laser

Interventions

  • Devicefractional microneedle radiofrequency

    group A are the keloid lesion that will receive The Fractional microneedle radiofrequency (FMR) sessions. the parameters which will be used for FMR is a power level of eight to nine, an exposure time of 800 ms, a depth of 2 mm (using non-insulated needles, 2Hz frequency, and 2 passes). followed by triamcinolone acetate solution at a dose of 0.25 ml/cm3 for keloids \< 3 cm and 0.5 ml/cm3 for keloids \>3 cm (equivalent to 10 mg/cm3 of TAC \[40 mg/vial\]) will be applied on the skin following the session and under occlusion using transparent film dressings. Sessions will be done 4 weeks apart for a duration of 3 months

  • Devicefractional co2 laser

    group b are the keloid lesion that will receive The Fractional carbon dioxide laser sessions. The parameters which will be used for fractional CO2-treated areas is a power of 18-20 W, 800-1000 μs dwell time, 500-600 μm spacing (13% density), microspotsize 120 μm, and two to three stacks) followed by triamcinolone acetate solution at a dose of 0.25 ml/cm3 for keloids \< 3 cm and 0.5 ml/cm3 for keloids \>3 cm (equivalent to 10 mg/cm3 of TAC \[40 mg/vial\]) will be applied on the skin following the session and under occlusion using transparent film dressings. Sessions will be done 4 weeks apart for a duration of 3 months

06

What researchers measure

Primary outcomes

  1. Compare the percentage of improvement in Detroit keloid scale score using combined Fractional microneedling radiofrequency (FMR)and steroid vs combined Fractional CO2 laser and steroid in keloid patients

    Time frame: 3 months

07

Study locations

No study locations are listed for this record.

08

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 27, 2026
Show all 1 update
  1. Oct 27, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07898605
Lead sponsor
Cairo University
Responsible party
Mona Mostafa Korany Mahmoud (lecturer of dermatology, Cairo university, Cairo University) — Principal investigator
First posted
Oct 27, 2026
Start date
Oct 20, 2026 (estimated)
Primary completion
Jan 16, 2027 (estimated)
Completion
Jan 31, 2027 (estimated)
Last update
Oct 27, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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