Michelle Ehrlich1, Jaggi Rao, Anju Pabby, Mitchel P Goldman. 1. American Society for Dermatologic Surgery Preceptorship Program, Dermatology/Cosmetic Laser Associates of La Jolla Inc., La Jolla, California, USA. MEhrlich@alumni.Princeton.edu
Abstract
BACKGROUND AND OBJECTIVE: Facial rhytides are a common cosmetic concern. Surgical treatment effects dramatic improvement; however, the associated risk and cost may be prohibitive. Recent focus is on developing topical products containing biologically active ingredients for at-home therapy. Our study examines the effects of a topical cream containing transforming growth factor-beta(1) (TGF-beta(1)), l-ascorbic acid, and Cimicifuga racemosa extract (CRS) (Topix Pharmaceuticals, North Amityville, NY, USA). MATERIALS AND METHODS: In the first arm of the study, 12 subjects were randomized to apply CRS to the left or right side of their face and a cream containing l-ascorbic acid and C. racemosa in silicone base (vitamin C [Vit C]) to the contralateral side twice daily for 3 months. In the second arm of the study, 20 subjects were randomized to apply CRS to the left or right side of their face and Tissue Nutrient Solution Recovery Complex (TNS) (SkinMedica, Carlsbad, CA, USA), a product containing a variety of growth factors including VEGF, PDGF-A, G-CSF, HGF, IL-6, IL-8, and TGF-beta(1) (Nouricel-MD) without l-ascorbic acid, C. racemosa extract, or silicone base, to the contralateral side of their face twice daily for 3 months. Digital photographs were scored by study-blinded physicians, and self-assessments were completed by all subjects at baseline and at the conclusion of the protocol. RESULTS:CRS and TNS were well tolerated, and all subjects completed the 3-month protocol for the CRS versus Vit C arm of the study. Physicians rated success in facial wrinkling scores on the CRS-treated side of the face for 27 of 31 subjects. Responders showed, on average, 21.7% improvement in physician-rated wrinkle scores. The mean improvement in the group of 31 patients as a whole was 12%. Eighteen of 31 subjects reported a noticeable improvement on their CRS-treated side. Both CRS and TNS demonstrate significant success between baseline and 3-month scores, and both growth factor products are superior to Vit C. Patients preferred CRS over TNS. CONCLUSION:CRS is effective in minimizing the appearance of facial rhytides. The success of the CRS product is largely attributable to the incorporation of TGF-beta(1).
RCT Entities:
BACKGROUND AND OBJECTIVE: Facial rhytides are a common cosmetic concern. Surgical treatment effects dramatic improvement; however, the associated risk and cost may be prohibitive. Recent focus is on developing topical products containing biologically active ingredients for at-home therapy. Our study examines the effects of a topical cream containing transforming growth factor-beta(1) (TGF-beta(1)), l-ascorbic acid, and Cimicifuga racemosa extract (CRS) (Topix Pharmaceuticals, North Amityville, NY, USA). MATERIALS AND METHODS: In the first arm of the study, 12 subjects were randomized to apply CRS to the left or right side of their face and a cream containing l-ascorbic acid and C. racemosa in silicone base (vitamin C [Vit C]) to the contralateral side twice daily for 3 months. In the second arm of the study, 20 subjects were randomized to apply CRS to the left or right side of their face and Tissue Nutrient Solution Recovery Complex (TNS) (SkinMedica, Carlsbad, CA, USA), a product containing a variety of growth factors including VEGF, PDGF-A, G-CSF, HGF, IL-6, IL-8, and TGF-beta(1) (Nouricel-MD) without l-ascorbic acid, C. racemosa extract, or silicone base, to the contralateral side of their face twice daily for 3 months. Digital photographs were scored by study-blinded physicians, and self-assessments were completed by all subjects at baseline and at the conclusion of the protocol. RESULTS:CRS and TNS were well tolerated, and all subjects completed the 3-month protocol for the CRS versus Vit C arm of the study. Physicians rated success in facial wrinkling scores on the CRS-treated side of the face for 27 of 31 subjects. Responders showed, on average, 21.7% improvement in physician-rated wrinkle scores. The mean improvement in the group of 31 patients as a whole was 12%. Eighteen of 31 subjects reported a noticeable improvement on their CRS-treated side. Both CRS and TNS demonstrate significant success between baseline and 3-month scores, and both growth factor products are superior to Vit C. Patients preferred CRS over TNS. CONCLUSION:CRS is effective in minimizing the appearance of facial rhytides. The success of the CRS product is largely attributable to the incorporation of TGF-beta(1).