search
Back to results

Revitalization of Damaged Skin Due to Chronic Skin Diseases

Primary Purpose

Chronic Eczema, Psoriasis, Atopic Dermatitis

Status
Unknown status
Phase
Early Phase 1
Locations
International
Study Type
Interventional
Intervention
ACE CSD
Sponsored by
Ace Cells Lab Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Eczema focused on measuring chronic skin disease, psoriasis, Eczema, atopic dermatitis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • ACE cells Lab Europe Doo
  • ACE Cells Lab Limited

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

internvention of Chrinic skin conditions

Arm Description

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

Outcomes

Primary Outcome Measures

Regeneration of the damaged skin lesion
Complete regeneration of the affected skin lesions from the skin disease.

Secondary Outcome Measures

Flare control
During the attacks of flare, the regenerated skin does not get affected nor show erythematous reaction

Full Information

First Posted
October 7, 2017
Last Updated
March 26, 2018
Sponsor
Ace Cells Lab Limited
search

1. Study Identification

Unique Protocol Identification Number
NCT03485560
Brief Title
Revitalization of Damaged Skin Due to Chronic Skin Diseases
Official Title
Revitalization of Damaged Sking Due to Chronic Skin Diseases
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2018 (Anticipated)
Primary Completion Date
November 1, 2018 (Anticipated)
Study Completion Date
January 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ace Cells Lab Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Eczema, Psoriasis, Atopic Dermatitis
Keywords
chronic skin disease, psoriasis, Eczema, atopic dermatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
internvention of Chrinic skin conditions
Arm Type
Experimental
Arm Description
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
Intervention Type
Combination Product
Intervention Name(s)
ACE CSD
Other Intervention Name(s)
ACE Skin immune
Intervention Description
Topical application of the ACE CSD 4 times daily.
Primary Outcome Measure Information:
Title
Regeneration of the damaged skin lesion
Description
Complete regeneration of the affected skin lesions from the skin disease.
Time Frame
6 - 9 months
Secondary Outcome Measure Information:
Title
Flare control
Description
During the attacks of flare, the regenerated skin does not get affected nor show erythematous reaction
Time Frame
1-3 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dr. Alaa Abdelkarim MF Mohammed
Phone
+447473922553
Email
dralaakarim@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dr. Diana Diana, MsC Dermatology
Email
dr.dianadiana@outlook.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Diana Diana, MSc Dermatology
Organizational Affiliation
ACE cells Lab europe DOO
Official's Role
Principal Investigator
Facility Information:
Facility Name
ACE cells Lab Europe Doo
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Diana Diana, MsC dermatology
Email
dr.dianadiana@outlook.com
Facility Name
ACE Cells Lab Limited
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG90 6BH
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Alaa Abdelkarim MF Mohammed, Consultant
Phone
7473922553
Email
dralaakarim@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Revitalization of Damaged Skin Due to Chronic Skin Diseases

We'll reach out to this number within 24 hrs