Document Detail


Six-month safety results of calcium hydroxylapatite for treatment of nasolabial folds in Fitzpatrick skin types IV to VI.
MedLine Citation:
PMID:  19708876     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Recently, the cosmetic market has seen an increase in the options for treatment for people with dark skin. OBJECTIVES: This study evaluates the use of calcium hydroxylapatite (CaHA), a dermal filler indicated for the correction of moderate to severe facial wrinkles and folds, including the nasolabial folds (NLFs) in individuals with dark skin. METHODS: This open-label, nonrandomized, prospective, five-center trial enrolled 100 patients aged 18 and older with Fitzpatrick skin types IV to VI. CaHA was injected subdermally with a 25- to 27-gauge needle. Participants received a range of 0.6 to 2.8 mL of CaHA and returned at 3 and 6 months to be assessed for keloid formation, hypertrophic scarring, and hyper- or hypopigmentation. If necessary, each subject was offered a touch-up at the conclusion of the 6-month visit. RESULTS: No reports of keloid formation, hypertrophic scarring, hypo- or hyperpigmentation, or other clinically significant adverse events were recorded. CONCLUSIONS: People with dark skin injected subdermally with CaHA do not show signs of keloid formation, hypertrophic scarring, or hyper- or hypopigmentation. Because of this safety feature, as well as other characteristics of the product already shown in clinical literature, CaHA is an attractive dermal filler in this population.
Authors:
Ellen S Marmur; Susan C Taylor; Pearl E Grimes; Charles M Boyd; Jennifer P Porter; Jane Y Yoo
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Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study     Date:  2009-08-25
Journal Detail:
Title:  Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.]     Volume:  35 Suppl 2     ISSN:  1524-4725     ISO Abbreviation:  Dermatol Surg     Publication Date:  2009 Oct 
Date Detail:
Created Date:  2009-10-07     Completed Date:  2009-12-21     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9504371     Medline TA:  Dermatol Surg     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1641-5     Citation Subset:  IM    
Affiliation:
Division of Dermatologic and Cosmetic Surgery, Department of Dermatology, Mount Sinai Medical Center, New York, New York 10029-6574, USA. Ellen.Marmur@MountSinai.org
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MeSH Terms
Descriptor/Qualifier:
Adult
Aged
Biocompatible Materials / administration & dosage,  adverse effects*
Cosmetic Techniques
Dermatologic Agents / administration & dosage,  adverse effects*
Durapatite / administration & dosage,  adverse effects*
Female
Follow-Up Studies
Humans
Keloid / chemically induced
Lip*
Male
Microspheres
Middle Aged
New York
Nose*
Patient Satisfaction
Prospective Studies
Rejuvenation*
Risk Assessment
Skin Aging / drug effects*
Skin Pigmentation*
Treatment Outcome
Chemical
Reg. No./Substance:
0/Biocompatible Materials; 0/Dermatologic Agents; 1306-06-5/Durapatite

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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