cutaneous aging
Conditions
Interventions
56 patients were randomized. 28 patients received oral hydrolyzed collagen 5g daily and 28 received placebo (oral maltodextrin), once a day, plus topics containing placebo (vehicle) or topical hydroly
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Sponsors
Universidade Federal de São Paulo
Universidade Federal de São Paulo
Eligibility
Sex/Gender
Female
Age
60 Years to No maximum
Inclusion criteria
Inclusion criteria: Women aged over 60 years, healthy, menopause; Phototypes II and III - Fitzpatrick classification 1988; Clinical diagnosis of stage I and IIa dermatoporosis in the forearms
Exclusion criteria
Exclusion criteria: Topical treatment of the forearms with retinoids, alpha-hydroxy acids, polyhydroxy acids, beta-hydroxy acids and ascorbic acid for less than 3 months; Topical treatment of the forearms with formulations containing collagen peptides for less than 3 months; Previous treatment with oral retinoids less than 6 months before; Pre-treatment with nutraceuticals and oral supplements less than 3 months before (except calcium and vitamin D); Treatment with superficial chemical peels, microdermabrasion and/or laser non-ablative in forearms for less than 3 months; Current smoking; Chronic use of corticosteroids (systemic or topical on the forearms) and/or chronic use of non-hormonal anti-inflammatory drugs; Chronic Kidney Failure; Insulin-dependent diabetes mellitus; Use of anticoagulants (including acetylsalicylic acid); Transplant patients; Presence of photodermatosis; Presence of inflammatory or infectious skin disease in the superior limbs; Chemotherapy for less than 3 months; Clinical evidence of immunosuppression; Hormone replacement therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected Outcome 1. Increase of dermal collagen I and elastin content and epidermal thickness, evaluated through cutaneous biopsy of a standardized area of the forearms before and after 24 weeks, with hematoxilin-eosin and immunohistochemical staining, with statistical significance. Measures in triplicate.;Outcome observed 1. There was no effect of topical or oral treatments, nor of the interaction between them on the thickness of the viable and total epidermis. There was no effect of topical or oral treatments, nor the interaction between them on the amount of dermal collagen. Contrary to expectations, oral hydrolyzed collagen significantly reduced the area of collagen. There was no effect of topical or oral treatments, nor of the interaction between them on the amount of dermal type I collagen and on the amount of elastin in the dermis. Contrary to expectations, in all groups, except for oral hydrolyzed collagen combined with topic collagen, there was a significant reduction in elastin. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome observed 2. The results of oral and topical treatments did not differ regarding the perception of improvement after 12 and 24 weeks. Analysis of the results of the blind evaluation by the investigator and two independent observers through photographs showed low agreement between the scores, with an intraclass correlation index of 0.229, which reinforces the difficulty of photographic evaluation for Dermatoporosis and the low efficacy of treatments.;Expected Outcome 1. Reduction of quality of life index scores after 12 and 24 weeks; through validated questionnaire DLQI (Dermatology Life Quality Index), with statistical significance;Expected Outcome 2. Clinical improvement according to investigator, independent observers and patients through photographic evaluation using five-point scale ( improved, much improved, inaltered, worse, much worse), at least one point of difference. ;Expected Outcome 3. Increase of at least ten percent in dermal echogenicity and thickness and pixel intensity of total and upper dermis in 12 and 24 weeks, using high frequency ultrasound (DermaScan) in a standardized area of the forearms. Measures in triplicate.;Expected Outcome 4. Increase in skin viscoelastic measures in 12 and 24 weeks, using Cutometer, in a starndardized area of the forearms, with statistical significance. Measures in triplicate. ;Outcome observed 1. The two treatments, oral hydrolyzed collagen and placebo reduced the impact of Dermatoporosis on quality of life, with no difference between them.;Outcome observed 3. The mean of the intensity measurements of the pixels in the upper dermis was higher in the group treated with oral placebo and topical hydrolyzed collagen , as well as in the group that received oral hydrolyzed collagen and topical placebo after 24 weeks. The mean increments of measurements of echogenicity, thickness and pixel intensity did not exceed ten percent between the times observed. None of the groups obtained a temporal gain in the parameters.; | — |
Countries
Brazil
Contacts
Public ContactLilia Guadanhim
Outcome results
None listed