Status unknownNCT04171427Updated Nov 20, 2019

Evaluation of the Efficacy and the Cutaneous Acceptability of a Dermocosmetic Product in the Repigmentation of Vitiligo

An interventional study of Lithium liposome and Placebo in Vitiligo, sponsored by Laboratoire Dermatologique ACM. Status unknown at 1 site in Tunisia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-11-20.

Sponsored by Laboratoire Dermatologique ACM · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2019), so the status shown — last known as Enrolling by invitation — may be out of date.

Phase: Not applicable
Study type: Interventional
Enrollment: 12
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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 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 studied

Vitiligo

Browse trials for

Vitiligo 343

In context

Vitiligo

343 studies on the registry are indexed under Vitiligo; 96 are open to participants now.

This study's planned enrollment of 12 is below the median of 36 across 265 interventional studies indexed under Vitiligo.

Browse Vitiligo studies →

Lead sponsor

Laboratoire Dermatologique ACM is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes

Eligibility criteria

•Inclusion Criteria: 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.
Healthy volunteer;
Volunteer having given in writing his free, informed and express consent;
Volunteer willing to abide by the protocol and procedures of the study.

Exclusion Criteria:

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;
Patient taking concomitant local or general 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.

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 12 participants (estimated)

Study arms

Other
Lithium liposome and placebo A
• 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;
Other: Lithium liposome · Other: Placebo
Other
Lithium liposome and placebo B
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;
Other: Lithium liposome · Other: Placebo
Other
Lithium liposome and placebo C
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.
Other: Lithium liposome · Other: Placebo

Interventions

OtherLithium liposome
Cosmetic product
OtherPlacebo
Cosmetic product vehicle

What researchers measure

Primary outcomes

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;
Time frame: 4 months

Secondary outcomes

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.
Time frame: 1 month, 2 months, 3 months

Study locations

1 site

Hbib thamer Hospital
Tunis, Tunisia

References and documents

Study documents

Protocol and statistical analysis plan ↗ · Oct 25, 2019

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2019; primary completion for May 2020, 6 months later.

Of 67 interventional studies with no phase under Vitiligo, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 32. This study's planned 6 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered: Nov 7, 2019
First posted: Nov 20, 2019
StartEst.: Nov 21, 2019
Primary completionEst.: May 2020
CompletionEst.: May 2020
Last update: Nov 20, 2019

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Nov 20, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04171427
Lead sponsor: Laboratoire Dermatologique ACM
Responsible party: Sponsor
First posted: Nov 20, 2019
Start date: Nov 21, 2019 (estimated)
Primary completion: May 2020 (estimated)
Completion: May 2020 (estimated)
Last update: Nov 20, 2019

Study contacts

Samy FENNICHE

principal investigator · Hbib Thamer Hosptal

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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