title: Tacrolimus ointment does not affect collagen synthesis: results of a single-center randomized trial.
abstract: We conducted a randomized, double-blind, placebo-controlled trial to assess the atrophogenicity of tacrolimus ointment. In a combined group of atopic dermatitis patients (n = 14) and healthy volunteers (n = 12), 0.3% tacrolimus, 0.1% tacrolimus, betamethasone-valerate, and a vehicle control were applied in a randomized order to nonsymptomatic, 4 cm x 4 cm regions of abdominal skin. After 7 d of treatment under occlusion, the carboxy- and amino-terminal propeptides of procollagen I (PICP, PINP) and the amino-terminal propeptide of procollagen III (PIIINP) were measured from suction blister fluid with specific radioimmunoassays. In addition, ultrasound measurements of skin thickness were taken. Betamethasone-treated areas showed median PICP, PINP, and PIIINP concentrations of 17.0%, 17.6%, and 39.5% of the vehicle control at the end of the treatment period, respectively, whereas the 0.1% and 0.3% tacrolimus-treated areas showed median concentrations of approximately 100% of the vehicle control (p < 0.001). Betamethasone was also the only treatment to reduce skin thickness; the median decrease in skin thickness was 7.4% relative to 0.1% tacrolimus, 7.1% relative to 0.3% tacrolimus, and 8.8% relative to the vehicle control (p < 0.01). Results for atopic dermatitis patients and healthy volunteers were similar. These findings suggest that tacrolimus does not cause skin atrophy.
authors.affiliation: Department of Dermatology, Helsinki University Central Hospital, Finland.
authors.forename: S
authors.initials: S
authors.lastname: Reitamo
authors.forename: J
authors.initials: J
authors.lastname: Rissanen
authors.forename: A
authors.initials: A
authors.lastname: Remitz
authors.forename: H
authors.initials: H
authors.lastname: Granlund
authors.forename: P
authors.initials: P
authors.lastname: Erkko
authors.forename: P
authors.initials: P
authors.lastname: Elg
authors.forename: P
authors.initials: P
authors.lastname: Autio
authors.forename: A I
authors.initials: AI
authors.lastname: Lauerma
mesh_terms: D000293:Adolescent; D000328:Adult; D003094:Collagen / Q000096:biosynthesis*; D003876:Dermatitis, Atopic / Q000188:drug therapy* / Q000378:metabolism; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009824:Ointments; D010446:Peptide Fragments / Q000378:metabolism; D011347:Procollagen / Q000378:metabolism; D012016:Reference Values; D016559:Tacrolimus / Q000627:therapeutic use*
chemical_list: D007166:Immunosuppressive Agents; D009824:Ointments; D010446:Peptide Fragments; D011347:Procollagen; C041876:procollagen Type III-N-terminal peptide; C042813:procollagen type I carboxy terminal peptide; D003094:Collagen; D016559:Tacrolimus