Web Based Investigation of Natural History of Keloid; An Online Survey of Patients with Keloid

Study Summary

STUDY OBJECTIVES

1- To prospectively collect clinical data from patients with keloid.

2- To correlate ethnic background and clinical presentation of keloid.

3- To prospectively follow the patients and correlate patient demographics and natural history of the disease with response to the past and future treatments.

4- To better understand prevalence of different clinical types of keloid

BACKGROUND / STUDY DISEASE

Keloids are benign, localized proliferations of cutaneous connective tissue secondary to an abnormal repair process characterized by excessive collagen or glycoprotein deposition in predisposed individuals. Despite their benign nature, keloids may constitute a severe aesthetic and, in some cases, functional problem with important repercussions on responders' quality of life. Keloids are mostly observed between ages of 10 and 30.

Although keloid is a fairly common condition; there are no statistics as to its true clinical presentation and how common each type of keloid is. This trial intends to gather very basic clinical information about keloid, its patterns of presentation, ethnic background and correlation with the type of keloid, as well as prior treatment results that patients have had received.

RATIONAL

The purposes and goals of current trial are to establish a robust database of clinical presentation of Keloid.

POPULATION SELECTION

Inclusion Criteria:

1- Patients must have clinically confirmed diagnosis of keloid

2- All Ages

3- Signed consent form ( by parent or legal guardian if patient is under the age of 18)

4- Able and willing to complete a web based survey

Exclusion Criteria:

No one will be excluded from this trial as long as the inclusion criteria are met.

Inclusion of Women, Minorities and Other Underrepresented Populations:

Investigator does not expect that the inclusion or exclusion criteria will impact the enrollment of women, minorities, or other underrepresented populations. Investigator encourages participation of women and minorities in this trial, as keloid affects mostly African American and Orientals.

Methods:

Informed Consent:

Investigator or their agents will set up a website, whereby patients will have to read and acknowledge the consent form online. Once patients agree and acknowledge the terms of the consent form, they will gain access to the online questionnaire.

All patients must electronically sign the consent form prior to participation in this trial. All patients will have access to the consent form online. Patients above age of 18 can sign and participate at will. For those who are under age of 18, a parent or a legal guardian must sign the consent form and answer the online questions on behalf of the patient.

Re-Contacting Patients:

Patient will be asked to consent to be re-contacted in future. Purpose of re-contact is to obtain more clinical information and to assess the natural history of the disease or to reach out to patient for other future keloid trials. Investigators will only re-contact those who have provided their consent to be re-contacted.