Efficacy of topical or oral hydrolyzed collagen for dermatoporosis in wome

Not Applicable

Terminated

• Conditions: cutaneous aging; C17.800

• Registration Number: RBR-7dnjqhd
• Lead Sponsor: niversidade Federal de São Paulo

Brief Summary

56 women, aged 60 to 93 years, with stage I Dermatoporosis, with cutaneous atrophy, senile purpura and stellate pseudoscars were included. The clinical study on the influence of collagen hydrolyzate showed that there was no effect of topical or oral treatments, nor of the interaction between them on the viable and total epidermis thickness and Picrosirius red, collagen I and elastin marking. During the observation period, there was no difference between oral treatments regarding viscoelastic parameters and the ultrasound aspects did not increase more than 10%. The treatments did not differ in terms of perceived improvement or impact on quality of life. Analysis by the investigator and two independent observers through photographs showed poor agreement between the scores. The average thickness of the total epidermis was 87 SD 36,06µm (SD: standard deviation) and of the viable epidermis was 49 µm SD 20,98. In the quantitative analysis of the forearm skin, the marking for picrosirius red, collagen I and elastin was 45.24 SD 8.30, 40.87 SD 12.02 and 19.17 SD 14.49 respectively. The viscoelastic parameters observed were, on average, R2 (0.62 SD 0.10), R5 (0.79 SD 1.02), R5(0.84 SD 3.19), R7(0.36 SD 0.09). The ultrasound parameters showed upper dermis thickness of 0.55 SD 0.09 mm and total dermis of 1.15 SD 0.19mm, echogenicity of upper dermis of 57 SD 15.64% and total dermis of 64.5 SD 11.76% and pixel intensity in the upper dermis of 39 SD 11.71% and the total dermis of 47 SD 10.54%. The impact of DP on patients' quality of life was low according to DLQI (dermatology quality of life index) .

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-05-31
• Study Start: 2022-01-21
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Terminated
• Sex: Female
• Target Recruitment: Not specified

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

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

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.