VitiligoPhase 3NCT01419964
Efficacy and Safety of ACH24 in the Treatment of Vitiligo
A Phase 3 study testing Group 01 and Group 02 in people with Vitiligo, run by Ache Laboratorios Farmaceuticos S.A. at 1 site in Brazil.
Trial summary
This is a multicenter clinical trial, phase III, randomized, placebo-controlled, parallel group, enroll 94 patients, to assess the efficacy of ACH24 in the repigmentation of achromatic areas in patients with vitiligo. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Vitiligo
- What is being tested?
- Group 01 and Group 02
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2012to Dec 2013
- Phase
- Phase 3
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of both sexes, aged between 18 and 65 years, remaining the feasibility of a legal guardian in accordance with need, able to understand and provide written informed consent and able to allow compliance at the treatment and the requirements of the protocol;
- Presence of generalized vitiligo;
- Able to comprehend and willing to provide written informed consent in accordance with institutional and regulatory guidelines.
Who cannot join
- Patients with:
- Inflammatory diseases;
- Alopecia Areata;
- Diabetes Type I;
- Asthma;
- Collagen disease;
Show all 15Show fewer
- Atopic dermatitis;
- Psoriasis;
- Autoimmune thyroid disease (self reported). ¬ Thyroid problems (represents 15% of people with vitiligo), exclude only those who need to do treatment with corticosteroid or immunosuppressive.
- Women of childbearing age who had tested positive for pregnancy, or who do not use acceptable contraceptive method, or do not agree to practice reliable contraception during the study;
- Woman in pregnancy or lactation period;
- Known allergic reaction against the phytomedicine as assessed by medical history;
- Patient that is taking any prohibited medication (Item 9.3);
- Participation in last one year of clinical protocols, unless it can be direct benefit to subject;
- Any finding of clinical observation (anamnesis and physical exam) laboratory abnormality (eg, blood glucose, blood count), disease (for example, liver, cardiovascular system, lung) or therapy that, in opinion of the investigator, may endanger the subject or interfere with the endpoints of study.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Irmandade da Santa Casa de Misericórdia de Curitiba
Curitiba, Paraná, 80010-030
About this study
Official title: Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Parallel Group Study of the Efficacy and Safety of ACH24 in the Treatment of Vitiligo
This is a multicenter clinical trial, phase III, randomized, placebo-controlled, parallel group, enroll 94 patients, to assess the efficacy of ACH24 in the repigmentation of achromatic areas in patients with vitiligo.
Read the detailed description
To evaluate the efficacy and safety of ACH24 compared to placebo in the treatment of vitiligo.The present study aims to register a new product in the country, the ACH24 for the treatment of vitiligo.
- Conditions
- Vitiligo
- Being tested
- Group 01, Group 02
- Keywords
- Vitiligo, Macular depigmentation, Stachytarpheta cayensensis
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 01Drug
Also called ACH24
ACH24
Group 02Drug
Also called PLACEBO
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Group 01 | Experimental | ACH24 Receives: Drug: Group 01 |
| Group 02 | Placebo comparator | Placebo Receives: Drug: Group 02 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Repigmentation of the affected area assessed by VASI (vitiligo area scoring index).
It is considered successful treatment a repigmentation of greater than or equal to 50% of the affected area assessed by VASI (vitiligo area scoring index).
Measured: Baseline compared to the end of 18 months of treatment
Secondary outcomes (2)
Quality of life questionnaire
Dermatology Life Quality Index (DLQI)
Measured: Baseline and each 12 weeks of treatment (V0, V3, V6, V9, V12, V15, V18)
Safety descriptive about occurence of adverse events, evaluation of results of general physical examination.
Collection of safety data throughout the whole study period
Measured: Will be evaluated during whole study, at the baseline and after 18 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2011 (estimated)
- Study startJan 2012
- Primary completionDec 2013 (estimated)
Why it stopped: The Brazilian regulatory agency - ANVISA has requested the cancellation of the phase 3 study for conducting a phase 1 study first.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VitiligoStudies 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
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ache Laboratorios Farmaceuticos S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- CAIO CASTRO, PHYSICIAN, Principal investigator, PUNTIFÍCIA UNIVERSIDADE CATÓLICA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01419964
- Sponsor's protocol ID
- ACH-VTL-03(09/11)
- Status last verified
- Mar 2016
- First submitted
- 17 Aug 2011
- Last updated
- 16 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Parallel Group Study of the Efficacy and Safety of ACH24 in the Treatment of Vitiligo
- ClinicalTrials.gov ID
- NCT01419964
- Acronym / sponsor ID
- ACH-VTL-03(09/11)
- Conditions
- Vitiligo
- Keywords
- Vitiligo, Macular depigmentation, Stachytarpheta cayensensis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The Brazilian regulatory agency - ANVISA has requested the cancellation of the phase 3 study for conducting a phase 1 study first.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ache Laboratorios Farmaceuticos S.A.Industry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Dec 2013 (estimated)
- First posted
- 19 Aug 2011 (estimated)
- 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.
This is a multicenter clinical trial, phase III, randomized, placebo-controlled, parallel group, enroll 94 patients, to assess the efficacy of ACH24 in the repigmentation of achromatic areas in patients with vitiligo.
Detailed description
To evaluate the efficacy and safety of ACH24 compared to placebo in the treatment of vitiligo.The present study aims to register a new product in the country, the ACH24 for the treatment of vitiligo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 01 | Experimental | Drug: Group 01ACH24 |
| Group 02 | Placebo comparator | Drug: Group 02Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients of both sexes, aged between 18 and 65 years, remaining the feasibility of a legal guardian in accordance with need, able to understand and provide written informed consent and able to allow compliance at the treatment and the requirements of the protocol;
- Presence of generalized vitiligo;
- Able to comprehend and willing to provide written informed consent in accordance with institutional and regulatory guidelines.
Key exclusion criteria (15 listed)
- Patients with:
- Women of childbearing age who had tested positive for pregnancy, or who do not use acceptable contraceptive method, or do not agree to practice reliable contraception during the study;
- Woman in pregnancy or lactation period;
- Known allergic reaction against the phytomedicine as assessed by medical history;
- Patient that is taking any prohibited medication (Item 9.3);
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 |
|---|---|---|
| Group 01Also: ACH24ACH24 | Drug | Group 01 |
| Group 02Also: PLACEBOPlacebo | Drug | Group 02 |
Primary outcome
Repigmentation of the affected area assessed by VASI (vitiligo area scoring index).
Time frame: Baseline compared to the end of 18 months of treatment
It is considered successful treatment a repigmentation of greater than or equal to 50% of the affected area assessed by VASI (vitiligo area scoring index).
2 secondary outcomes
Quality of life questionnaire
Time frame: Baseline and each 12 weeks of treatment (V0, V3, V6, V9, V12, V15, V18)
Safety descriptive about occurence of adverse events, evaluation of results of general physical examination.
Time frame: Will be evaluated during whole study, at the baseline and after 18 months of treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2016.
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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.
CAIO CASTRO, PHYSICIAN principal investigator
PUNTIFÍCIA UNIVERSIDADE CATÓLICA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Group 01 and Group 02 in people with Vitiligo, run by Ache Laboratorios Farmaceuticos S.A. at 1 site in Brazil.
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 15 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: withdrawn, as of the sponsor's last update on 16 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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. Some participants in this study may receive a placebo. 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?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Repigmentation of the affected area assessed by VASI (vitiligo area scoring index). (time frame: Baseline compared to the end of 18 months of treatment). 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 16 Mar 2016.