An interventional study of Intralesional Cryotherapy + Saline Injection and Intralesional Cryotherapy + TAC/5-FU Injection in Keloid, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-13.
Sponsored by Assiut University · Not applicable, Interventional, and Treatment
evaluate the efficacy and safety of intralesional cryosurgery alone compared with intralesional cryosurgery combined with intralesional 5-fluorouracil and triamcinolone acetonide in the treatment of keloids.
Keloids are abnormal scars characterized by excessive collagen deposition that extends beyond the original wound boundaries, often leading to cosmetic disfigurement, pain, pruritus, and tenderness, significantly affecting patients' quality of life . Keloid formation is influenced by genetic predisposition, skin tension, wound location, and inflammatory responses, and they are notorious for high recurrence rates, with some reports indicating recurrence in up to 50-80% of cases after treatment .
Various therapeutic modalities have been used for the management of keloids. These treatment options can be broadly classified into intralesional therapies, topical therapies, and procedural interventions.
Despite the availability of multiple treatment options, no single therapy ensures complete resolution, and recurrence remains a significant challenge in keloid management .
Intralesional corticosteroids remain the first-line therapy, reducing fibroblast proliferation, collagen synthesis, and local inflammation. Clinical studies have shown flattening of keloids in 50-70% of patients with repeated injections . Another commonly used intralesional agent is 5-fluorouracil (5-FU), an antimetabolite that inhibits fibroblast proliferation and extracellular matrix deposition, with reported improvement in 70-80% of cases . Combination therapy of corticosteroids and 5-FU has demonstrated superior efficacy compared with monotherapy.
Among procedural modalities. Intralesional (IL) cryotherapy, is a technique in which a cryogen can be applied using a cryoneedle directly into the deeper dermis of the scar to produce rapid scar freezing from the core outwards, thus all the pathological tissue will be frozen and destructed, creating a new scar without keloidal characteristics, while sparing the surface epithelium. As a monotherapy, IL cryosurgery has yielded promising clinical results in terms of volume reduction and alleviation of pain and pruritus . Marked efficacy of a single intralesional cryosurgery session has been recorded even in voluminous keloids, which is an additional major advantage compared with the repeated sessions required in classical contact cryosurgery, However, on average, no complete scar eradication is attained and scar recurrence is seen. Also, persistent hypopigmentation remains problematic in nonwhite patients . These issues raise the question whether IL cryotherapy could be used in combination with nonsurgical therapies to augment the therapeutic effect and to lower the risk of hypopigmentation.
Weshahy and Abdel Hay and Stromps et combined IL cryotherapy with adjuvant therapy with silicone sheeting and triamcinolone injections, respectively .
Eisert and Nast reported good outcomes by initially using intralesional cryosurgery, followed by injection of triamcinolone, 5-fluorouracil and hyaluronidase, suggesting that such treatment also leads to significant softening of the keloid, which would otherwise be too firm to be treated with intralesional injections
Although several studies have evaluated the effectiveness of intralesional corticosteroids, 5-fluorouracil, and cryotherapy individually, data directly comparing intralesional cryotherapy with combined intralesional corticosteroid and 5-fluorouracil therapy remain limited in the literature .
The study aims to investigate whether intralesional injection of a mixture of 5-fluorouracil (5-FU) and triamcinolone acetonide (TAC) as adjuvant therapy to intralesional cryosurgery produces superior outcomes in terms of scar improvement, recurrence reduction, and hypopigmentation control.
138 studies on the registry are indexed under Keloid; 26 are open to participants now.
This study's planned enrollment of 32 is close to the median of 30 across 109 interventional studies indexed under Keloid.
Browse Keloid studies →Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will receive a single session of intralesional cryotherapy followed by intralesional saline injection as a placebo. Saline injections will be repeated at 4-week intervals for a total of four sessions to maintain blinding and follow-up consistency with the experimental group. Patients and care providers are not blinded. Two independent blinded observers will evaluate scar characteristics using OSAS and VSS
Procedure: Intralesional Cryotherapy + Saline Injection
Patients will receive a single session of intralesional cryotherapy followed immediately by intralesional injection of a combination of triamcinolone acetonide (TAC, 40 mg/mL) and 5-fluorouracil (5-FU, 50 mg/mL) in a ratio of 1:9. Further intralesional injections of TAC and 5-FU will be administered at 4-week intervals for a total of four sessions. Patients and care providers are not blinded. Two independent blinded observers will evaluate scar characteristics using OSAS and VSS.
Procedure: Intralesional Cryotherapy + TAC/5-FU Injection
Patients will receive a single session of intralesional cryotherapy followed by intralesional saline injection as a placebo. Saline injections will be repeated at 4-week intervals for a total of four sessions to maintain blinding and follow-up consistency with the experimental group. Patients and care providers are not blinded. Two independent blinded observers will evaluate scar characteristics using OSAS and VSS
Patients will receive a single session of intralesional cryotherapy followed immediately by intralesional injection of a combination of triamcinolone acetonide (TAC, 40 mg/mL) and 5-fluorouracil (5-FU, 50 mg/mL) in a ratio of 1:9. Further intralesional injections of TAC and 5-FU will be administered at 4-week intervals for a total of four sessions. Patients and care providers are not blinded. Two independent blinded observers will evaluate scar characteristics using OSAS and VSS.
Change in keloid size
Keloid severity will be assessed using the Vancouver Scar Scale (VSS), which evaluates vascularity, pigmentation, pliability, and height. Scores range from 0 to 13, with higher scores indicating more severe scarring. Assessment will be performed by blinded observers.
Time frame: 12 weeks
Patient Scar Assessment (PSAS)
Patient-reported outcomes will be evaluated using the Patient Scar Assessment Scale (PSAS), which assesses pain, pruritus, color, stiffness, thickness, and irregularity. Scores range from 6 to 60, with higher scores indicating worse scar quality.
Time frame: up to 12 weeks
Change in dermoscopic vascular patterns and pigmentation
Dermoscopy will be used to document and evaluate changes in vascular patterns, pigmentation, and structural features of the keloid. Observations will be compared between baseline and 12 weeks to assess changes
Time frame: up to 12 weeks
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