Response Evaluation Criteria in Keloid Disorder (RECORD)
Response Evaluation Criteria in Patients with Keloid Disorder (RECORD), a novel framework proposed by KRF Founder, Michael H. Tirgan, MD and first presented at the 5th international Keloid Symposium in Shanghai, china.
Historically, many publications have relied on the Vancouver Burn Scar Scale (VBSS) to assess treatment outcomes in keloid patients. However, the VBSS was developed for burn scars and lacks specificity for the unique pathophysiology and clinical behavior of keloidal lesions.
The RECORD criteria offer the first KD-specific methodology designed to objectively evaluate the therapeutic efficacy of various treatment modalities. The approach is intended to be both simple and practical, making it suitable for clinical practice as well as research settings.
As a pioneering effort in standardizing response assessment in Keloid Disorder, the RECORD criteria will require ongoing validation, refinement, and integration into future clinical studies. The introduction of RECORD marks a significant advancement toward establishing meaningful and disease-relevant outcome measures in KD research.
RECORD adopts a methodology analogous to the well-established RECIST (Response Evaluation Criteria in Solid Tumors) used in oncology [XX], adapting it specifically for the unique features of Keloid Disorder.
The following response categories were proposed and accepted by the expert panel:
- Complete Remission (CR):
Defined as the complete disappearance of the keloidal lesion(s) following treatment. - Near-Complete Remission (N-CR):
Defined as the near-total resolution of the keloidal lesion(s), with only a minimal amount of residual tissue at the base of the treated site(s) that may still require additional therapy to achieve CR. - Partial Remission (PR):
Defined as a ≥30% reduction in the sum of diameters or volume of the target keloidal lesions compared to baseline measurements. - Stable Disease (SD):
Defined as a response that does not meet the criteria for Partial Remission (PR) or Progressive Disease (PD). In other words, there is no significant reduction or increase in lesion size. - Progressive Disease (PD):
Defined as a ≥20% increase in the sum of diameters of target lesions, with an absolute increase of at least 5 mm, or the appearance of new keloidal lesions.
Additional Measures for Assessing Treatment Efficacy
Time to Response (TTR)
Time to Response (TTR) refers to the duration between the initiation of treatment and the point at which a measurable therapeutic response is observed. TTR is typically very short or immediate following surgical excision of a keloidal lesion. In contrast, it is often prolonged when non-surgical modalities such as cryotherapy or intralesional injections are used.
TTR is a clinically relevant parameter and should be systematically recorded at each follow-up visit, as it provides valuable insight into the efficacy and dynamics of the treatment approach.
Duration of Response (DR)
Duration of Response (DR) is defined as the length of time from the initial achievement of a treatment response—whether complete, near-complete, or partial—until the recurrence or regrowth of the treated keloidal lesion is detected. DR is a critical measure for evaluating the long-term effectiveness and durability of a given therapy.
Loss of Normal Ear Anatomy
The ear is a common site for keloid formation. While surgical excision of ear keloids may result in complete remission (CR), it often comes at the cost of altered or lost normal ear anatomy. This disfigurement, though sometimes overlooked in clinical reporting, has significant psychosocial and aesthetic consequences for patients and should not be understated.
The expert panel emphasized that any loss of normal ear structure—including partial ear tissue loss or distortion of natural contours—must be fully documented and disclosed by the treating physician. Despite the frequency with which such outcomes are observed in clinical practice, they are rarely reported in the literature or formal outcome assessments. Accurate reporting of these adverse effects is essential to ensure transparent risk-benefit discussions and to improve treatment planning.
Worsening of Keloids After Surgery
Although commonly observed in clinical practice, worsening of keloidal lesions following surgical excision is rarely acknowledged in the surgical literature. While Limandjaja et al. (2020) referenced worsened outcomes after surgical resection, this was done only in passing and without detailed discussion.
To date, the only published surgical data that explicitly documents worsening of keloids comes from a landmark study by Escarmant et al. (1993). In their report, the authors shared their extensive experience managing 544 patients with 783 keloids in Martinique using a combination of surgical excision and adjuvant interstitial radiation therapy. In-person follow-up was successfully obtained for 361 patients with a total of 570 treated keloids. 50% of the patients were under the age of 20 and 51.4% had earlobe keloids. The study showed 81.1% (450 keloids) clinical improvement and 9.4% (52 keloids) worsened keloids after surgery and radiation therapy.
This study remains a rare but important reference highlighting the risk of disease progression following surgical intervention, particularly in younger patients and those with earlobe lesions. The lack of broader acknowledgment in the surgical literature underscores the need for more rigorous, outcome-focused research on the role—and risks—of surgery in the management of Keloid Disorder.
As part of the RECORD (Response Evaluation Criteria in Patients with Keloid Disorder) framework, it is essential that all keloid treatment protocols explicitly report the rate of lesion worsening among treated patients. This critical data point—often overlooked in clinical studies—provides meaningful insight into the safety and long-term effectiveness of therapeutic interventions. Documenting and publishing the rate of keloid progression or exacerbation ensures transparency, facilitates comparative analysis across treatments, and helps clinicians make more informed, evidence-based decisions for patient care.
