VitiligoNCT04171427
Evaluation of the Efficacy and the Cutaneous Acceptability of a Dermocosmetic Product in the Repigmentation of Vitiligo
A study testing Lithium liposome in people with Vitiligo, run by Laboratoire Dermatologique ACM at 1 site in Tunisia.
Trial summary
Study in proof of concept; Double blind study; Comparative study, versus placebo in intra-individual Three parallel groups testing different dosages / combinations of treatments Randomized. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vitiligo
- What is being tested?
- Lithium liposome
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteTunisia
- Study dates
- 21 Nov 2019to May 2020
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Pregnant woman or woman who is breastfeeding or planning for early pregnancy during the study;
- Patient with segmental or mixed vitiligo;
- Patient with vitiligo of the external genitalia;
- Patient with vitiligo touching hands and feet only
- Patient with a history of skin cancer or pre-cancerous skin lesions;
- Patient taking topical or systemic vitiligo treatments in the month prior to the start of the study;
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- Patient taking concomitant local or general corticosteroid therapy or immunomodulatory therapy;
- Patient with a history of photodermatoses or taking photosensitizing medications;
- Patient having planned to expose himself (artificial sun or UV) during the study at the level of the zones to be treated and / or having been exposed during the month preceding the beginning of the study and having an acquired pigmentation (tanning) obvious;
- Patient who had been treated with phototherapy within 4 weeks before randomization;
- Patient with lithium allergy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Efficacy and the Cutaneous Acceptability of a Dermocosmetic Product in the Repigmentation of Vitiligo -Study Realized by a Dermatologist-
- Study in proof of concept;
- Double blind study;
- Comparative study, versus placebo in intra-individual
- Three parallel groups testing different dosages / combinations of treatments
- Randomized.
Read the detailed description
This study has as objectives:
Primary objective :
- Evaluate the percentage of repigmentation observed one month after the end of three months of treatment measured on an objective layer by image analysis;
Secondary objectives:
Evaluate:
- the percentage of repigmentation observed after one, two and three months of treatment measured on an objective layer by image analysis;
- the ability of the product to maintain the human body in good condition (cutaneous acceptability) by clinical examination by the dermatologist;
- Patient satisfaction using a visual analogue scale from 0 to 10.
- The illustrative effect using standardized photographs;
- The quantity of product by weighing the tubes.
- The occurrence of possible adverse effects.
Population:
- Sexe: female and male;
- Age: over 18 years old;
- Patients with stable non-segmental vitiligo lesions (defined as no new lesions or lesions that have been present for at least 3 months, lack of hypochromic margins in Wood's lumen and absence of confetti depigmentation);
- Patients with 2 to 6 symmetrical lesions (1 to 3 on each side). These lesions (macules) will be treated for a minimum surface of 2 cm² and a maximum surface of 100 cm².
- Conditions
- Vitiligo
- Being tested
- Lithium liposome, Placebo
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lithium liposomeOther
Cosmetic product
PlaceboOther
Cosmetic product vehicle
| Study group | Role | What they receive |
|---|---|---|
| Lithium liposome and placebo A | Other | • Group A : 4 patients; Lithium liposome 1 application / day (evening) on target lesions on one side of the body, placebo 1 application / day (evening) on contralateral target lesions and excimer lamp on target lesions on the two sides; Receives: Other: Lithium liposome; Other: Placebo |
| Lithium liposome and placebo B | Other | Group B : 4 patients; Liposomal Lithium 2 applications / day (morning and evening) on target lesions on one side of the body, placebo 2 applications / day (morning and evening) on contralateral target lesions and excimer lamp on target lesions on the two sides; Receives: Other: Lithium liposome; Other: Placebo |
| Lithium liposome and placebo C | Other | Groupe C : 4 patients; Lithium liposome 2 applications / day (morning and evening) on one side, placebo 2 applications / day (morning and evening) on contralateral target lesions. Receives: Other: Lithium liposome; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
the percentage of repigmentation
- Evaluate the percentage of repigmentation observed one month after the end of three months of treatment measured on an objective layer by image analysis;
Measured: 4 months
Secondary outcomes (1)
the percentage of repigmentation and acceptability
the percentage of repigmentation observed after one, two and three months of treatment measured on an objective layer by image analysis;
- the ability of the product to maintain the human body in good condition (cutaneous acceptability) by clinical examination by the dermatologist;
- Patient satisfaction using a visual analogue scale from 0 to 10.
- The illustrative effect using standardized photographs;
- The quantity of product by weighing the tubes.
- The occurrence of possible adverse effects.
Measured: 1 month, 2 months, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2019
- Study start21 Nov 2019 (estimated)
- Primary completionMay 2020 (estimated)
- Study completionMay 2020 (estimated)
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three parallel groups testing different dosages / combinations of treatments
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laboratoire Dermatologique ACM
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Samy FENNICHE, Principal investigator, Hbib Thamer Hosptal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04171427
- Sponsor's protocol ID
- 18E1721
- Status last verified
- Oct 2019
- First submitted
- 7 Nov 2019
- Last updated
- 20 Nov 2019
- 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 20 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and the Cutaneous Acceptability of a Dermocosmetic Product in the Repigmentation of Vitiligo -Study Realized by a Dermatologist-
- ClinicalTrials.gov ID
- NCT04171427
- Acronym / sponsor ID
- 18E1721
- Conditions
- Vitiligo
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Laboratoire Dermatologique ACMIndustry (pharma, biotech, devices)
- Study start
- 21 Nov 2019 (estimated)
- Primary completion
- May 2020 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 20 Nov 2019 (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.
- Study in proof of concept;
- Double blind study;
- Comparative study, versus placebo in intra-individual
- Three parallel groups testing different dosages / combinations of treatments
- Randomized.
Detailed description
This study has as objectives:
Primary objective :
- Evaluate the percentage of repigmentation observed one month after the end of three months of treatment measured on an objective layer by image analysis;
Secondary objectives:
Evaluate:
- the percentage of repigmentation observed after one, two and three months of treatment measured on an objective layer by image analysis;
- the ability of the product to maintain the human body in good condition (cutaneous acceptability) by clinical examination by the dermatologist;
- Patient satisfaction using a visual analogue scale from 0 to 10.
- The illustrative effect using standardized photographs;
- The quantity of product by weighing the tubes.
- The occurrence of possible adverse effects.
Population:
- Sexe: female and male;
- Age: over 18 years old;
- Patients with stable non-segmental vitiligo lesions (defined as no new lesions or lesions that have been present for at least 3 months, lack of hypochromic margins in Wood's lumen and absence of confetti depigmentation);
- Patients with 2 to 6 symmetrical lesions (1 to 3 on each side). These lesions (macules) will be treated for a minimum surface of 2 cm² and a maximum surface of 100 cm².
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Three parallel groups testing different dosages / combinations of treatments
| Arm | Type | Receives |
|---|---|---|
| Lithium liposome and placebo A | Other | Other: Lithium liposome, Other: Placebo• Group A : 4 patients; Lithium liposome 1 application / day (evening) on target lesions on one side of the body, placebo 1 application / day (evening) on contralateral target lesions and excimer lamp on target lesions on the two sides; |
| Lithium liposome and placebo B | Other | Other: Lithium liposome, Other: PlaceboGroup B : 4 patients; Liposomal Lithium 2 applications / day (morning and evening) on target lesions on one side of the body, placebo 2 applications / day (morning and evening) on contralateral target lesions and excimer lamp on target lesions on the two sides; |
| Lithium liposome and placebo C | Other | Other: Lithium liposome, Other: PlaceboGroupe C : 4 patients; Lithium liposome 2 applications / day (morning and evening) on one side, placebo 2 applications / day (morning and evening) on contralateral target lesions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (11 listed)
- Pregnant woman or woman who is breastfeeding or planning for early pregnancy during the study;
- Patient with segmental or mixed vitiligo;
- Patient with vitiligo of the external genitalia;
- Patient with vitiligo touching hands and feet only
- Patient with a history of skin cancer or pre-cancerous skin lesions;
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 |
|---|---|---|
| Lithium liposomeCosmetic product | Other | Lithium liposome and placebo A, Lithium liposome and placebo B, Lithium liposome and placebo C |
| PlaceboCosmetic product vehicle | Other | Lithium liposome and placebo A, Lithium liposome and placebo B, Lithium liposome and placebo C |
Primary outcome
the percentage of repigmentation
Time frame: 4 months
• Evaluate the percentage of repigmentation observed one month after the end of three months of treatment measured on an objective layer by image analysis;
1 secondary outcome
the percentage of repigmentation and acceptability
Time frame: 1 month, 2 months, 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2019.
- 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.
Samy FENNICHE principal investigator
Hbib Thamer Hosptal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lithium liposome in people with Vitiligo, run by Laboratoire Dermatologique ACM at 1 site in Tunisia.
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 0 inclusion and 11 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 20 Nov 2019. 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 Tunisia. 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.
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?
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?
the percentage of repigmentation (time frame: 4 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 20 Nov 2019.