IntraDerm Pharmaceuticals’ Celacyn scar management gel received FDA approval as a prescription product in December 2014. It is a dimethicone (modified silicone) based gel containing Microcyn Technology (stabilized hypochlorous acid/ HOCl). Microcyn Technology, which is the science of stabilizing hypochlorous acid/ HOCl, is a wound-healing agent with a mechanism of action that provides the ideal wound-healing environment. Combined with the silicone base vehicle, this provides a possible scar treatment option.
Celacyn is for post-procedure and scar management treatment. It is intended for the management of old and new hypertrophic and keloid scars resulting from burns, general surgical procedures and trauma wounds. The gel has been clinically shown to improve the texture, color, softness and overall appearance of scars.
Before applying Celacyn, individuals should clean the affected area and pat dry. The gel should be applied in a thin layer to the scar area 3 times per day (or as recommended by a healthcare provider) and massaged gently into the skin. The recommended length of treatment is 8 weeks. Individuals should allow the treated area to air dry completely. Once dry, Celacyn can be covered with cosmetics or pressure garments, according to the product’s prescribing information.
A randomized, double-blind, multicenter, 16-week study evaluated the efficacy and tolerability of Celacyn scar management gel as compared to Kelo-cote (Advanced Bio-Technologies, Inc.) scar gel in adult patients with hypertrophic or keloid scars. The results demonstrated that Celacyn was effective for the treatment of hypertrophic and keloid scars as reflected by improvements in Vancouver Scar Scale (VSS) scores, individual signs and symptoms (ie, itch and pain) and Investigator Global Assessment (IGA) and patient satisfaction with treatment.1
The Dermatologist Product Spotlight provides a summary of the double-blind study that assessed the efficacy and safety of Celacyn versus Kelo-cote for the management of hypertrophic or keloid scars in patients age 18 to 65 years.
Double-blind Study
Bucko AD, Draelos Z, Dubois JC, Jones TM. A double-blind, randomized study to compare microcyn scar management hydrogel, K103163, and Kelo-cote scar gel for hypertrophic or keloid scars. Poster presented at: 14th Annual Caribbean Dermatology Symposium; January 20-24, 2015; St. Maarten.1
Study Objective
To evaluate the efficacy, safety, and tolerability of Celacyn versus Kelo-cote scar gel (100% silicone gel) in adult patients with hypertrophic or keloid scars that were 3 months to 1 year old.1
Method
The randomized, double-blind, multicenter, 16-week study was conducted at 4 sites. Patients with a target linear or widespread hypertrophic or keloid scar resulting from a wound that had healed 3 to 12 months earlier and had a minimum VSS total score of 3 in a body area that could be assessed for evaluation were randomized 1:1 to Celacyn (N=22) or Kelo-cote (N=22) and treated for 58 days. A designated device dispenser applied the first dose of treatment to the target scar. Each patient received one 1.5 oz tube of the treatment gel at each of 3 visits: baseline (day 0), day 14 (week 2), and day 28 (week 4), for a total of 3 tubes, with the instructions to apply the gel 3 times daily, approximately 8 hours apart, for 8 weeks.1
Patients returned to the clinic for follow-up visits on days 14, 28, 56 (week 8, end of treatment) and 84 and 112 (weeks 12 and 16, follow-up). Investigators carried out VSS evaluations at baseline and at days 14, 28, 56, 84 and 112. IGA was performed at day 56 and 112 (or early termination). At these visits, the investigator rated the efficacy of the device as very good, good, moderate or unsatisfactory. Patients evaluated pain and itch at baseline and at days 14, 28, 56, 84 and 112 (or early termination). At day 56 and 112 (or early termination), patients rated global satisfaction with treatment as very good, good, moderate or unsatisfactory.1
Population
A total of 44 patients age 18 to 65 years were randomized to Celacyn or Kelo-cote; overall 38 patients (N=20 for Celacyn and N=18 for Kelo-cote) completed the study. Women of childbearing potential who had a negative urine pregnancy test at baseline and agreed to use an effective method of birth control during the study were eligible. Patients were excluded if they had a history of allergy or sensitivity to any components of the study treatment; a history of diabetes or collagen vascular disorders that could impact healing and wound repair; a target scar on the face; a scar that spanned over a joint or required the use of a pressure bandage and a scar that was newer than 3 months or older than 1 year. Major or diffuse keloids were excluded as target lesions. Scar sizes were larger for patients in the Celacyn treatment arm compared to the Kelo-cote treatment arm; scar types were well-balanced between treatment groups.1
Primary Endpoint
Change in VSS total scores from baseline to day 112, and change in patient-related pain and itch. Also, IGA and patients’ satisfaction assessments at day 56 and 112 were conducted.1
Results
The researchers found that the vascularity, pliability and height of target scars, as measured by the VSS, improved consistently throughout the study. At day 56, the mean total VSS decreased by −2.10 and −1.28 in the Celacyn and Kelo-cote groups, respectively; and this improvement continued through the week 16 final visit with decreases of −2.70 and −1.83, respectively. Pain and itch decreased in both groups with greater improvement with Celacyn versus Kelo-cote; however, no significant differences were observed between treatment groups. The IGA of efficacy was good/very good in 30% of patients in the Celacyn group at day 56 and 55% at day 112 versus 27.8% at both time points for patients in Kelo-cote group. In the Celacyn group, the patients’ overall satisfaction with scar treatment efficacy was good/very good for 40% at day 56 and 45% at day 112; in the Kelo-cote group, the respective values were 44.4% at day 56 and 55.6% at day 112.1
Safety Notes
Overall, 18.2% of patients in the Celacyn group and 35% in the Kelo-cote group experienced a treatment-emergent adverse event (TEAE). The most frequently reported TEAEs for patients receiving Celacyn or Kelo-cote were infections (4.5% vs 15%, respectively) and gastrointestinal disorders (4.5% vs 5%, respectively). Nearly all the TEAEs were mild or moderate in severity. There was 1 serious TEAE in the Celacyn group (rectal perforation unrelated to study treatment) that resolved after the conclusion of the study and no serious TEAEs in the Kelo-cote group. No TEAEs resulted in withdrawal from the study in either group.1
Additional Resource
Celacyn is available by prescription. For additional information, please visit https://intraderm.com/celacyn-scar-management-gel.
IntraDerm Pharmaceuticals’ Celacyn scar management gel received FDA approval as a prescription product in December 2014. It is a dimethicone (modified silicone) based gel containing Microcyn Technology (stabilized hypochlorous acid/ HOCl). Microcyn Technology, which is the science of stabilizing hypochlorous acid/ HOCl, is a wound-healing agent with a mechanism of action that provides the ideal wound-healing environment. Combined with the silicone base vehicle, this provides a possible scar treatment option.
Celacyn is for post-procedure and scar management treatment. It is intended for the management of old and new hypertrophic and keloid scars resulting from burns, general surgical procedures and trauma wounds. The gel has been clinically shown to improve the texture, color, softness and overall appearance of scars.
Before applying Celacyn, individuals should clean the affected area and pat dry. The gel should be applied in a thin layer to the scar area 3 times per day (or as recommended by a healthcare provider) and massaged gently into the skin. The recommended length of treatment is 8 weeks. Individuals should allow the treated area to air dry completely. Once dry, Celacyn can be covered with cosmetics or pressure garments, according to the product’s prescribing information.
A randomized, double-blind, multicenter, 16-week study evaluated the efficacy and tolerability of Celacyn scar management gel as compared to Kelo-cote (Advanced Bio-Technologies, Inc.) scar gel in adult patients with hypertrophic or keloid scars. The results demonstrated that Celacyn was effective for the treatment of hypertrophic and keloid scars as reflected by improvements in Vancouver Scar Scale (VSS) scores, individual signs and symptoms (ie, itch and pain) and Investigator Global Assessment (IGA) and patient satisfaction with treatment.1
The Dermatologist Product Spotlight provides a summary of the double-blind study that assessed the efficacy and safety of Celacyn versus Kelo-cote for the management of hypertrophic or keloid scars in patients age 18 to 65 years.
Double-blind Study
Bucko AD, Draelos Z, Dubois JC, Jones TM. A double-blind, randomized study to compare microcyn scar management hydrogel, K103163, and Kelo-cote scar gel for hypertrophic or keloid scars. Poster presented at: 14th Annual Caribbean Dermatology Symposium; January 20-24, 2015; St. Maarten.1
Study Objective
To evaluate the efficacy, safety, and tolerability of Celacyn versus Kelo-cote scar gel (100% silicone gel) in adult patients with hypertrophic or keloid scars that were 3 months to 1 year old.1
Method
The randomized, double-blind, multicenter, 16-week study was conducted at 4 sites. Patients with a target linear or widespread hypertrophic or keloid scar resulting from a wound that had healed 3 to 12 months earlier and had a minimum VSS total score of 3 in a body area that could be assessed for evaluation were randomized 1:1 to Celacyn (N=22) or Kelo-cote (N=22) and treated for 58 days. A designated device dispenser applied the first dose of treatment to the target scar. Each patient received one 1.5 oz tube of the treatment gel at each of 3 visits: baseline (day 0), day 14 (week 2), and day 28 (week 4), for a total of 3 tubes, with the instructions to apply the gel 3 times daily, approximately 8 hours apart, for 8 weeks.1
Patients returned to the clinic for follow-up visits on days 14, 28, 56 (week 8, end of treatment) and 84 and 112 (weeks 12 and 16, follow-up). Investigators carried out VSS evaluations at baseline and at days 14, 28, 56, 84 and 112. IGA was performed at day 56 and 112 (or early termination). At these visits, the investigator rated the efficacy of the device as very good, good, moderate or unsatisfactory. Patients evaluated pain and itch at baseline and at days 14, 28, 56, 84 and 112 (or early termination). At day 56 and 112 (or early termination), patients rated global satisfaction with treatment as very good, good, moderate or unsatisfactory.1
Population
A total of 44 patients age 18 to 65 years were randomized to Celacyn or Kelo-cote; overall 38 patients (N=20 for Celacyn and N=18 for Kelo-cote) completed the study. Women of childbearing potential who had a negative urine pregnancy test at baseline and agreed to use an effective method of birth control during the study were eligible. Patients were excluded if they had a history of allergy or sensitivity to any components of the study treatment; a history of diabetes or collagen vascular disorders that could impact healing and wound repair; a target scar on the face; a scar that spanned over a joint or required the use of a pressure bandage and a scar that was newer than 3 months or older than 1 year. Major or diffuse keloids were excluded as target lesions. Scar sizes were larger for patients in the Celacyn treatment arm compared to the Kelo-cote treatment arm; scar types were well-balanced between treatment groups.1
Primary Endpoint
Change in VSS total scores from baseline to day 112, and change in patient-related pain and itch. Also, IGA and patients’ satisfaction assessments at day 56 and 112 were conducted.1
Results
The researchers found that the vascularity, pliability and height of target scars, as measured by the VSS, improved consistently throughout the study. At day 56, the mean total VSS decreased by −2.10 and −1.28 in the Celacyn and Kelo-cote groups, respectively; and this improvement continued through the week 16 final visit with decreases of −2.70 and −1.83, respectively. Pain and itch decreased in both groups with greater improvement with Celacyn versus Kelo-cote; however, no significant differences were observed between treatment groups. The IGA of efficacy was good/very good in 30% of patients in the Celacyn group at day 56 and 55% at day 112 versus 27.8% at both time points for patients in Kelo-cote group. In the Celacyn group, the patients’ overall satisfaction with scar treatment efficacy was good/very good for 40% at day 56 and 45% at day 112; in the Kelo-cote group, the respective values were 44.4% at day 56 and 55.6% at day 112.1
Safety Notes
Overall, 18.2% of patients in the Celacyn group and 35% in the Kelo-cote group experienced a treatment-emergent adverse event (TEAE). The most frequently reported TEAEs for patients receiving Celacyn or Kelo-cote were infections (4.5% vs 15%, respectively) and gastrointestinal disorders (4.5% vs 5%, respectively). Nearly all the TEAEs were mild or moderate in severity. There was 1 serious TEAE in the Celacyn group (rectal perforation unrelated to study treatment) that resolved after the conclusion of the study and no serious TEAEs in the Kelo-cote group. No TEAEs resulted in withdrawal from the study in either group.1
Additional Resource
Celacyn is available by prescription. For additional information, please visit https://intraderm.com/celacyn-scar-management-gel.
IntraDerm Pharmaceuticals’ Celacyn scar management gel received FDA approval as a prescription product in December 2014. It is a dimethicone (modified silicone) based gel containing Microcyn Technology (stabilized hypochlorous acid/ HOCl). Microcyn Technology, which is the science of stabilizing hypochlorous acid/ HOCl, is a wound-healing agent with a mechanism of action that provides the ideal wound-healing environment. Combined with the silicone base vehicle, this provides a possible scar treatment option.
Celacyn is for post-procedure and scar management treatment. It is intended for the management of old and new hypertrophic and keloid scars resulting from burns, general surgical procedures and trauma wounds. The gel has been clinically shown to improve the texture, color, softness and overall appearance of scars.
Before applying Celacyn, individuals should clean the affected area and pat dry. The gel should be applied in a thin layer to the scar area 3 times per day (or as recommended by a healthcare provider) and massaged gently into the skin. The recommended length of treatment is 8 weeks. Individuals should allow the treated area to air dry completely. Once dry, Celacyn can be covered with cosmetics or pressure garments, according to the product’s prescribing information.
A randomized, double-blind, multicenter, 16-week study evaluated the efficacy and tolerability of Celacyn scar management gel as compared to Kelo-cote (Advanced Bio-Technologies, Inc.) scar gel in adult patients with hypertrophic or keloid scars. The results demonstrated that Celacyn was effective for the treatment of hypertrophic and keloid scars as reflected by improvements in Vancouver Scar Scale (VSS) scores, individual signs and symptoms (ie, itch and pain) and Investigator Global Assessment (IGA) and patient satisfaction with treatment.1
The Dermatologist Product Spotlight provides a summary of the double-blind study that assessed the efficacy and safety of Celacyn versus Kelo-cote for the management of hypertrophic or keloid scars in patients age 18 to 65 years.
Double-blind Study
Bucko AD, Draelos Z, Dubois JC, Jones TM. A double-blind, randomized study to compare microcyn scar management hydrogel, K103163, and Kelo-cote scar gel for hypertrophic or keloid scars. Poster presented at: 14th Annual Caribbean Dermatology Symposium; January 20-24, 2015; St. Maarten.1
Study Objective
To evaluate the efficacy, safety, and tolerability of Celacyn versus Kelo-cote scar gel (100% silicone gel) in adult patients with hypertrophic or keloid scars that were 3 months to 1 year old.1
Method
The randomized, double-blind, multicenter, 16-week study was conducted at 4 sites. Patients with a target linear or widespread hypertrophic or keloid scar resulting from a wound that had healed 3 to 12 months earlier and had a minimum VSS total score of 3 in a body area that could be assessed for evaluation were randomized 1:1 to Celacyn (N=22) or Kelo-cote (N=22) and treated for 58 days. A designated device dispenser applied the first dose of treatment to the target scar. Each patient received one 1.5 oz tube of the treatment gel at each of 3 visits: baseline (day 0), day 14 (week 2), and day 28 (week 4), for a total of 3 tubes, with the instructions to apply the gel 3 times daily, approximately 8 hours apart, for 8 weeks.1
Patients returned to the clinic for follow-up visits on days 14, 28, 56 (week 8, end of treatment) and 84 and 112 (weeks 12 and 16, follow-up). Investigators carried out VSS evaluations at baseline and at days 14, 28, 56, 84 and 112. IGA was performed at day 56 and 112 (or early termination). At these visits, the investigator rated the efficacy of the device as very good, good, moderate or unsatisfactory. Patients evaluated pain and itch at baseline and at days 14, 28, 56, 84 and 112 (or early termination). At day 56 and 112 (or early termination), patients rated global satisfaction with treatment as very good, good, moderate or unsatisfactory.1
Population
A total of 44 patients age 18 to 65 years were randomized to Celacyn or Kelo-cote; overall 38 patients (N=20 for Celacyn and N=18 for Kelo-cote) completed the study. Women of childbearing potential who had a negative urine pregnancy test at baseline and agreed to use an effective method of birth control during the study were eligible. Patients were excluded if they had a history of allergy or sensitivity to any components of the study treatment; a history of diabetes or collagen vascular disorders that could impact healing and wound repair; a target scar on the face; a scar that spanned over a joint or required the use of a pressure bandage and a scar that was newer than 3 months or older than 1 year. Major or diffuse keloids were excluded as target lesions. Scar sizes were larger for patients in the Celacyn treatment arm compared to the Kelo-cote treatment arm; scar types were well-balanced between treatment groups.1
Primary Endpoint
Change in VSS total scores from baseline to day 112, and change in patient-related pain and itch. Also, IGA and patients’ satisfaction assessments at day 56 and 112 were conducted.1
Results
The researchers found that the vascularity, pliability and height of target scars, as measured by the VSS, improved consistently throughout the study. At day 56, the mean total VSS decreased by −2.10 and −1.28 in the Celacyn and Kelo-cote groups, respectively; and this improvement continued through the week 16 final visit with decreases of −2.70 and −1.83, respectively. Pain and itch decreased in both groups with greater improvement with Celacyn versus Kelo-cote; however, no significant differences were observed between treatment groups. The IGA of efficacy was good/very good in 30% of patients in the Celacyn group at day 56 and 55% at day 112 versus 27.8% at both time points for patients in Kelo-cote group. In the Celacyn group, the patients’ overall satisfaction with scar treatment efficacy was good/very good for 40% at day 56 and 45% at day 112; in the Kelo-cote group, the respective values were 44.4% at day 56 and 55.6% at day 112.1
Safety Notes
Overall, 18.2% of patients in the Celacyn group and 35% in the Kelo-cote group experienced a treatment-emergent adverse event (TEAE). The most frequently reported TEAEs for patients receiving Celacyn or Kelo-cote were infections (4.5% vs 15%, respectively) and gastrointestinal disorders (4.5% vs 5%, respectively). Nearly all the TEAEs were mild or moderate in severity. There was 1 serious TEAE in the Celacyn group (rectal perforation unrelated to study treatment) that resolved after the conclusion of the study and no serious TEAEs in the Kelo-cote group. No TEAEs resulted in withdrawal from the study in either group.1
Additional Resource
Celacyn is available by prescription. For additional information, please visit https://intraderm.com/celacyn-scar-management-gel.
