KeloidsNCT07898605
Fractional Radiofrequency With Streroids Versus Fractional CO2 Laser With Steroids in the Treatment of Keloids
A study testing fractional microneedle radiofrequency and fractional co2 laser in people with Keloids, run by Cairo University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Keloids
- What is being tested?
- fractional microneedle radiofrequency and fractional co2 laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 20 Oct 2026to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Topical or intralesional steroid treatment for keloid in the last 3 months
- Lidocaine sensitivity
- Pregnancy and lactation
- Severe systemic illness or malignancy
- Bacterial infections, other infections such as HBV, HCV or HIV.
- Age below 18 years.
- Ear Keloids
- Patients who are currently on oral isotretinoin or systemic steroid drugs.
About this study
Official title: Comparing the Efficacy of Fractional Radiofrequency Versus Fractional CO2 Laser in Transepidermal Delivery of Steroids for the Treatment of Keloids: a Randomized Controlled Trial
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 .
- Conditions
- Keloids
- Being tested
- fractional microneedle radiofrequency, fractional co2 laser
- Medical subject headings
- Keloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fractional microneedle radiofrequencyDevice
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
fractional co2 laserDevice
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
| Study group | Role | What they receive |
|---|---|---|
| group A | Active comparator | Keloid lesion receiving fractional radiofrequency and topical triamcinolone Receives: Device: fractional microneedle radiofrequency |
| group B | Active comparator | Keloid lesion receiving fractional carbon dioxide laser and topical triamcinolone Receives: Device: fractional co2 laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start20 Oct 2026 (estimated)
- Primary completion16 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KeloidsStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona Mostafa Korany Mahmoud, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07898605
- Sponsor's protocol ID
- Dermatology 26
- Status last verified
- Oct 2026
- First submitted
- 18 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Efficacy of Fractional Radiofrequency Versus Fractional CO2 Laser in Transepidermal Delivery of Steroids for the Treatment of Keloids: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07898605
- Acronym / sponsor ID
- Dermatology 26
- Conditions
- Keloids
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Oct 2026 (estimated)
- Primary completion
- 16 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 27 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | Active comparator | Device: fractional microneedle radiofrequencyKeloid lesion receiving fractional radiofrequency and topical triamcinolone |
| group B | Active comparator | Device: fractional co2 laserKeloid lesion receiving fractional carbon dioxide laser and topical triamcinolone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (8 listed)
- Topical or intralesional steroid treatment for keloid in the last 3 months
- Lidocaine sensitivity
- Pregnancy and lactation
- Severe systemic illness or malignancy
- Bacterial infections, other infections such as HBV, HCV or HIV.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fractional microneedle radiofrequencygroup 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 | Device | group A |
| fractional co2 lasergroup 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 | Device | group B |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
Related trials for Keloids
Active, not recruiting
Transdermal Versus Intralesional Betamethasone for Keloids
Keloid
RecruitingPhase 2
Ritlecitinib in Patients With Keloids or Those Undergoing Keloidectomy
Keloid
Recruiting
Radiotherapy for Keloids
Keloid
Not yet recruitingPhase 2
siRNA Microneedle Patches for Ear Keloid Post-Surgical Scars
Keloid of Ear Lobe
RecruitingObservational study
Keloid Pathogenesis And Fibroblast Activation Study
Keloids, Fibroblast
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing fractional microneedle radiofrequency and fractional co2 laser in people with Keloids, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.