"A Clinical Study Investigating the Effectiveness of OTC Scar-management Modalities"
Scar, Keloid, Hypertrophic Scar
About this trial
This is an interventional treatment trial for Scar focused on measuring Scar, Keloid, Hypertrophic Scar, Cicatrix
Eligibility Criteria
Inclusion Criteria:
- Male or female
- Adult, Senior (>18 years of age)
- Healthy or medically stable
- Keloid or hypertrophic scar
- Willing and able to follow study requirements
- Etiology and clinical assessment of the scar indicate that it could benefit from the study treatments
Exclusion Criteria:
- Subjects who are medically unstable
- Subjects who are expected to be medically unstable for the duration of the study period and an additional 1-month thereafter
- Pregnant subjects, or those attempting to become pregnant
- Subjects with known immunosuppression or immunosuppressive illness
- Subjects with uncontrolled diabetes or autoimmune disorders
- Subjects with known sensitivity to ingredients in the test-treatment products
- Subjects who are enrolled in another scar study and/or plan to receive or are receiving scar treatments other than study treatment during the trial period
- Subjects who have received scar treatment, including any investigational treatment, within one month of the first day of study treatment
- Subjects with any skin conditions or taking any medications that may interfere with the study medication
- Subjects who had any clinical evidence of severe ongoing or prolonged depression, mental illness, and/or who has demonstrated evidence of drug abuse
- Any other diagnosis, condition, physical or geographical limitation that may render, or increases the likelihood of rendering, the Subject unable to complete the entire study
Sites / Locations
- The Center for Clinical and Cosmetic Research
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
FS2 Emulsion Moisturizer
Active Comparator + FS2 Emulsion Moisturizer
The FS2 Emulsion Moisturizer Arm is comprised of three (3) topical treatments including: Placebo Cream Base Emulsion Moisturizer, FS2 Emulsion Moisturizer and Active Comparator Onion Skin Extract Gel (Mederma). The topical treatments are applied b.d. for 120 days.
The Active Comparator + FS2 Emulsion Moisturizer Arm is comprised of two (2) topical treatments including: Active Comparator Silicone Gel (Kelo-Cote), and Active Comparator Silicone Gel (Kelo-Cote) + FS2 Emulsion Moisturizer. The topical treatments are applied b.d. for 120 days.