NCT03485560

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started May 2018

Shorter than P25 for early_phase_1

Geographic Reach
2 countries

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 7, 2017

Completed
6 months until next milestone

First Posted

Study publicly available on registry

April 2, 2018

Completed
29 days until next milestone

Study Start

First participant enrolled

May 1, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

April 2, 2018

Status Verified

November 1, 2017

Enrollment Period

6 months

First QC Date

October 7, 2017

Last Update Submit

March 26, 2018

Conditions

Keywords

chronic skin diseasepsoriasisEczemaatopic dermatitis

Outcome Measures

Primary Outcomes (1)

  • Regeneration of the damaged skin lesion

    Complete regeneration of the affected skin lesions from the skin disease.

    6 - 9 months

Secondary Outcomes (1)

  • Flare control

    1-3 months

Study Arms (1)

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

Combination Product: ACE CSD

Interventions

ACE CSDCOMBINATION_PRODUCT

Topical application of the ACE CSD 4 times daily.

Also known as: ACE Skin immune
internvention of Chrinic skin conditions

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • patients on steroid.
  • patients intolerable to protein or allergic to proteins
  • during pregnancy or lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

ACE cells Lab Europe Doo

Belgrade, 11000, Serbia

Location

ACE Cells Lab Limited

Nottingham, Nottinghamshire, NG90 6BH, United Kingdom

Location

MeSH Terms

Conditions

PsoriasisDermatitis, AtopicEczema

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Dr. Diana Diana, MSc Dermatology

    ACE cells Lab europe DOO

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Alaa Abdelkarim MF Mohammed

CONTACT

Dr. Diana Diana, MsC Dermatology

CONTACT

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2017

First Posted

April 2, 2018

Study Start

May 1, 2018

Primary Completion

November 1, 2018

Study Completion

January 1, 2019

Last Updated

April 2, 2018

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations