- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03485560
Revitalization of Damaged Skin Due to Chronic Skin Diseases
Revitalization of Damaged Sking Due to Chronic Skin Diseases
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Anticipated)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
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Belgrade, Serbia, 11000
- ACE cells Lab Europe Doo
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Nottinghamshire
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Nottingham, Nottinghamshire, United Kingdom, NG90 6BH
- ACE Cells Lab Limited
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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EXPERIMENTAL: internvention of Chrinic skin conditions
All cases of chronic skin conditions will be included to measure the effect on the 3 of them and whihc one will respond to the treatment better
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Topical application of the ACE CSD 4 times daily.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Regeneration of the damaged skin lesion
Time Frame: 6 - 9 months
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Complete regeneration of the affected skin lesions from the skin disease.
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6 - 9 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Flare control
Time Frame: 1-3 months
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During the attacks of flare, the regenerated skin does not get affected nor show erythematous reaction
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1-3 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dr. Diana Diana, MSc Dermatology, ACE cells Lab Europe Doo
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ACEcsd
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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