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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03485560
Other study ID # ACEcsd
Secondary ID
Status Not yet recruiting
Phase Early Phase 1
First received October 7, 2017
Last updated March 26, 2018
Start date May 1, 2018
Est. completion date January 1, 2019

Study information

Verified date November 2017
Source Ace Cells Lab Limited
Contact Dr. Alaa Abdelkarim MF Mohammed
Phone +447473922553
Email dralaakarim@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Chronic skin disease lead to skin damage and disfiguring to the patient skin. Sometimes, achieving normal skin is not possible by the normal traditional treatment, this study is focusing on use of ACE CSD formula which is mixture of natural peptides and herbs. the main aim is to restore the normal skin appearance for the patient and control the episodes of flare.


Description:

Psoriasis is a chronic, immune mediated (type 2 and type 17) chronic skin disease. The production of the immune proteins that leads to continuous inflammatory mediated process. The result of chronic inflammation is they hyper keratotic layer of skin which gets attacks of atopic dermatitis leading to symptoms of itching, pruritis and in situ bleeding.

ACE CSD, with the multiple factors that mediates the immune response and control the protein receptors, in addition to the multiple regeneration peptides that are specifically extracted from healthy skin of newly born sheep; in addition to multiple Chinese herbs that contains different anabolic factors was tested to be able to regenerate the damaged skin and locally modulate the immunity reactions so the skin can regenerate fully to replace the damaged skin with normal healthy skin.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 200
Est. completion date January 1, 2019
Est. primary completion date November 1, 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Chronic skin condition lasts for more than 1 year.

- tried traditional treatment with limited or without effect.

- not on steroids for at least 6 weeks.

Exclusion Criteria:

- patients on steroid.

- patients intolerable to protein or allergic to proteins

- during pregnancy or lactation

Study Design


Intervention

Combination Product:
ACE CSD
Topical application of the ACE CSD 4 times daily.

Locations

Country Name City State
Serbia ACE cells Lab Europe Doo Belgrade
United Kingdom ACE Cells Lab Limited Nottingham Nottinghamshire

Sponsors (1)

Lead Sponsor Collaborator
Ace Cells Lab Limited

Countries where clinical trial is conducted

Serbia,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Regeneration of the damaged skin lesion Complete regeneration of the affected skin lesions from the skin disease. 6 - 9 months
Secondary Flare control During the attacks of flare, the regenerated skin does not get affected nor show erythematous reaction 1-3 months
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