Chronic EczemaEarly Phase 1NCT03485560
Revitalization of Damaged Skin Due to Chronic Skin Diseases
A Early Phase 1 study testing ACE CSD in people with Chronic Eczema and Psoriasis, run by Ace Cells Lab Limited at 2 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Eczema, Psoriasis, Atopic Dermatitis
- What is being tested?
- ACE CSD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 May 2018to 1 Jan 2019
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- patients on steroid.
- patients intolerable to protein or allergic to proteins
- during pregnancy or lactation
Trial locations and contacts
2 sites in 2 countries.
Dr. Diana Diana, MsC Dermatology contact
2 sites in 2 countries
Serbia1 site
ACE cells Lab Europe Doo
Belgrade, 11000
Dr. Diana Diana, MsC dermatology, dr.dianadiana@outlook.com
United Kingdom1 site
ACE Cells Lab Limited
Nottingham, Nottinghamshire, NG90 6BH
Dr. Alaa Abdelkarim MF Mohammed, Consultant, 7473922553, dralaakarim@gmail.com
About this study
Official title: Revitalization of Damaged Sking Due to Chronic Skin Diseases
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.
Read the 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.
- Conditions
- Chronic Eczema, Psoriasis, Atopic Dermatitis
- Being tested
- ACE CSD
- Keywords
- chronic skin disease, psoriasis, Eczema, atopic dermatitis
- Medical subject headings
- Psoriasis, Dermatitis, Atopic, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACE CSDCombination product
Also called ACE Skin immune
Topical application of the ACE CSD 4 times daily.
| Study group | Role | What they receive |
|---|---|---|
| internvention of Chrinic skin conditions | Experimental | 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 Receives: Combination Product: ACE CSD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regeneration of the damaged skin lesion
Complete regeneration of the affected skin lesions from the skin disease.
Measured: 6 - 9 months
Secondary outcomes (1)
Flare control
During the attacks of flare, the regenerated skin does not get affected nor show erythematous reaction
Measured: 1-3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2018
- Study start1 May 2018 (estimated)
- Primary completion1 Nov 2018 (estimated)
- Study completion1 Jan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic EczemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ace Cells Lab Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Diana Diana, MSc Dermatology, Principal investigator, ACE cells Lab europe DOO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03485560
- Sponsor's protocol ID
- ACEcsd
- Status last verified
- Nov 2017
- First submitted
- 7 Oct 2017
- Last updated
- 2 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Revitalization of Damaged Sking Due to Chronic Skin Diseases
- ClinicalTrials.gov ID
- NCT03485560
- Acronym / sponsor ID
- ACEcsd
- Conditions
- Chronic Eczema, Psoriasis, Atopic Dermatitis
- Keywords
- chronic skin disease, psoriasis, Eczema, atopic dermatitis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Ace Cells Lab LimitedIndustry (pharma, biotech, devices)
- Study start
- 1 May 2018 (estimated)
- Primary completion
- 1 Nov 2018 (estimated)
- Study completion
- 1 Jan 2019 (estimated)
- First posted
- 2 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| internvention of Chrinic skin conditions | Experimental | Combination Product: ACE CSDAll 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- patients on steroid.
- patients intolerable to protein or allergic to proteins
- during pregnancy or lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACE CSDAlso: ACE Skin immuneTopical application of the ACE CSD 4 times daily. | Combination product | internvention of Chrinic skin conditions |
Primary outcome
Regeneration of the damaged skin lesion
Time frame: 6 - 9 months
Complete regeneration of the affected skin lesions from the skin disease.
1 secondary outcome
Flare control
Time frame: 1-3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Diana Diana, MsC Dermatology contact
Dr. Diana Diana, MSc Dermatology principal investigator
ACE cells Lab europe DOO
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing ACE CSD in people with Chronic Eczema and Psoriasis, run by Ace Cells Lab Limited at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Serbia, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr. Alaa Abdelkarim MF Mohammed (+447473922553, dralaakarim@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regeneration of the damaged skin lesion (time frame: 6 - 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2018.