Abstract
Background
Cicatryl™ cream, a topical medical device, is indicated for the treatment of superficial wounds and small skin injuries.
Objectives
To assess the efficacy and tolerability of Cicatryl™ cream by measuring the recovery of the skin barrier after inducing wounds.
Materials & Methods
A suction blister of about 6-mm diameter was induced on the inner side of each forearm of 44 healthy subjects. Using a process of randomisation, Cicatryl™ cream was then applied to one wound for a maximum duration of 14 days, while the other wound was left untreated. The primary objective was to evaluate the effect of the test product on wound healing at Day 6, by comparing treated versus untreated wound areas measured by macrophotography. Secondary objectives were to evaluate healing, cutaneous barrier restoration and subjective efficacy of the cream as well as tolerability.
Results
The mean wound area (± SD) at Day 6 was significantly smaller for treated wounds compared with untreated wounds (1.76 ± 4.71 vs 15.76 ± 7.61 mm2; p < 0.0001). For treated wounds, wound healing between Days 1 and 6 was 1.6-fold faster compared with untreated wounds (−7.90 vs−4.79 mm2/day; p < 0.0001), and the wounds healed in approximately half the time (6.8 vs 12.2 days for untreated wounds). Cutaneous barrier restoration occurred earlier for treated wounds (Day 6 vs Day 8 for untreated wounds). The cream was well tolerated, and no serious adverse events were observed.
Conclusion
Cicatryl™ cream improves wound healing, especially within the first six days, if applied in accordance with the manufacturer’s instructions.
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References
Gushiken LFS, Beserra FP, Bastos JK, Jackson CJ, Pellizzon CH. Cutaneous wound healing: an update from physiopathology to current therapies. Life 2021; 11: 665.
Kottner J, Hillmann K, Fimmel S, Seité S, Blume-Peytavi U. Characterisation of epidermal regeneration in vivo: a 60-day follow-up study. J Wound Care 2013; 22: 395–400.
Kuhlmann M, Wigger-Alberti W, Mackensen Yv W, et al. Wound healing characteristics of a novel wound healing ointment in an abrasive wound model: a randomised, intra-individual clinical investigation. Wound Med 2019; 24: 24–32.
Pang C, Ibrahim A, Bulstrode NW, Ferretti P. An overview of the therapeutic potential of regenerative medicine in cutaneous wound healing. Int Wound J 2017; 14: 450–9.
Korting HC, Schöllmann C, White RJ. Management of minor acute cutaneous wounds: importance of wound healing in a moist environment. J Eur Acad Dermatol Venereol 2011; 25: 130–7.
Junker JPE, Kamel RA, Caterson EJ, Eriksson E. Clinical impact upon wound healing and inflammation in moist, wet, and dry environments. Adv Wound Care 2013; 2: 348–56.
Schultz GS, Sibbald RG, Falanga V, et al. Wound bed preparation: a systematic approach to wound management. Wound Repair Regen 2003; 11: S1–28.
Singer AJ, Dagum AB. Current management of acute cutaneous wounds. N Engl J Med 2008; 359: 1037–46.
Gorski J, Proksch E, Baron JM, Schmid D, Zhang L. Dexpanthenol in wound healing after medical and cosmetic interventions (postprocedure wound healing). Pharmaceuticals 2020; 13: 138.
Smith TJ, Wilson MA, Young AJ, Montain SJ. A suction blister model reliably assesses skin barrier restoration and immune response. J Immunol Methods 2015; 417: 124–30.
Koivukangas V, Oikarinen A. Suction blister model of wound healing. In: DiPietro LA, Burns AL, editors. Wound healing: methods and protocols. Totowa, NJ: Humana Press, 2003, 255–61.
Wilhelm K-P, Wilhelm D, Bielfeldt S. Models of wound healing: an emphasis on clinical studies. Skin Res Technol 2017; 23: 3–12.
Fitzpatrick T, Pathak M, Parrish J. Protection of human skin against the effects of the sunburn ultraviolet (290–320 nm). In: Sunlight and Man: Normal and Abnormal Photobiologic Responses. Totowa, NJ: University of Tokyo Press, 1974, 751–5.
Franz MG, Robson MC, Steed DL, et al. Guidelines to aid healing of acute wounds by decreasing impediments of healing. Wound Repair Regen 2008; 16: 723–48.
Yoshino Y, Ohtsuka M, Kawaguchi M, et al. Wound/Burn Guidelines Committee. The wound/burn guidelines — 6: Guidelines for the management of burns. J Dermatol 2016; 43: 989–1010.
Makvandi P, Caccavale C, Della Sala F, Zeppetelli S, Veneziano R, Borzacchiello A. Natural formulations provide antioxidant complement to hyaluronic acid-based topical applications used in wound healing. Polymers 2020; 12: 1847.
Caddeo C, Manca ML, Peris JE, et al. Tocopherol-loaded transfersomes: in vitro antioxidant activity and efficacy in skin regeneration. Int J Pharm 2018; 551: 34–41.
Ferraq Y, Black DR, Theunis J, Mordon S. Superficial wounding model for epidermal barrier repair studies: comparison of Erbium:YAG laser and the suction blister method. Lasers Surg Med 2012; 44: 525–32.
Silverman RA, Lender J, Elmets CA. Effects of occlusive and semiocclusive dressings on the return of barrier function to transepidermal water loss in standardized human wounds. J Am Acad Dermatol 1989; 20: 755–60.
Acknowledgments
The authors would like to acknowledge Mitali Choudhury, PhD, of Springer Healthcare Communications for medical writing assistance and Alain Delarue, MD, for proofreading the manuscript.
Funding
Pierre Fabre Medical Direction and ProDerm GmbH funded this study and medical writing assistance.
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Conflicts of interest
Alexia Brocario, Stephan Maurel, Christophe Lauze and Stephanie Favrel are employees of Laboratoires Pierre Fabre. Katharina Kapoor is an employee of ProDerm GmbH and has a contractual service agreement with Laboratoires Pierre Fabre.
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Brocario, A., Maurel, S., Kapoor, K. et al. Assessment of wound healing efficacy and tolerability using Cicatryl™ cream based on a suction blister model in healthy subjects. Eur J Dermatol 32, 762–769 (2022). https://doi.org/10.1684/ejd.2022.4355
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DOI: https://doi.org/10.1684/ejd.2022.4355