AzTrials
AzTrials

Leishmaniasis, CutaneousPhase 3NCT05708625

Intralesional Voriconazole, or Intralesional Cryotherapy, or Oral Doxycycline in the Treatment of Cutaneous Leishmaniasis

A Phase 3 study testing Intralesional Sodium stibogluconate, Intralesional Cryotherapy and Intralesional Voriconazole in people with Leishmaniasis, Cutaneous, run by Zagazig University at 1 site in Libya.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Leishmaniasis is a vector-borne disease caused by obligate, intracellular protozoa of the genus Leishmania and transmitted by phlebotomine sandflies. It is found mostly in tropical and subtropical areas then it has spread into southern Europe. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Leishmaniasis, Cutaneous
What is being tested?
Intralesional Sodium stibogluconate, Intralesional Cryotherapy and Intralesional Voriconazole
Could I receive a placebo?
No, everyone receives an active treatment
How many people
136 participants
Where
1 siteLibya
Study dates
1 Jan 2022to 1 Mar 2024
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 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • All participants must be willing to sign informed consent, for patients younger than 18 years old, parents or guardians will sign an informed consent.
  • Patients clinically diagnosed with cutaneous leishmaniasis and confirmed using parasitological Giemsa-stained direct smears.
  • Acute lesions of less than 12-week duration to exclude any possibility of natural self-healing of the lesions during follow-up.
  • Both sexes.
  • Age: > 12 years old.

Who cannot join

  • • Pregnancy and lactation.
  • Patients < 12 years old.
  • Patients with negative Giemsa stained direct smears.
  • Patients with concomitant renal or liver impairment, congestive heart failure, uncontrolled diabetes mellitus, peripheral neuropathy, poor peripheral circulation, and prolonged corticosteroid therapy.
  • Patients with lesions of more than 12 weeks duration.
  • Patients with lesions > 5cm2
Show all 10Show fewer
  • History of anti-Leishmania therapy in the last 3 months.
  • For the intralesional groups the presence of > 5 lesions.
  • Lesions in the perimeter (< 2 cm) of mucosal areas e.g. eyes, nose, mouth, or genitals.
  • Patients with known hypersensitivity or allergy to the assigned drugs.

Trial locations and contacts

1 site in 1 country.

Hagar Nofal, Dr. contact

01006387707

hagarnofal@aucegypt.edu

Libya1 site, 1 recruiting

  • Dermatology department, Gharyan University Hospitals, Medical College, Gharyan University

    Gharyan, Select Region

    Hagar Nofal, Dr., 01006387707, hagarnofal@aucegypt.edu

    Recruiting

About this study

Official title: Efficacy of Intralesional Voriconazole Versus Intralesional Cryotherapy Versus Intralesional Sodium Stibogluconate Versus Oral Doxycycline in the Treatment of Acute Cutaneous Leishmaniasis

Leishmaniasis is a vector-borne disease caused by obligate, intracellular protozoa of the genus Leishmania and transmitted by phlebotomine sandflies. It is found mostly in tropical and subtropical areas then it has spread into southern Europe. Increased international travel and immigration have led to an increased diagnosis of leishmaniasis cases in nonendemic areas (Kollipara et al., 2016). Foci of CL, caused by L. ma¬jor, occur in Afghanistan, Egypt, Iran, Iraq, Jordan, Libya, Morocco, Palestine, Pakistan, Saudi Arabia, Sudan, Syria, Tunisia, and Yemen. Many researchers have studied leishmaniasis in the endemic northern African countries, e.g., Morocco, Algeria, Tunisia, Egypt, and Libya. One of the established endemic leishmaniasis Libyan provinces is Al-jabal Al-gharbi province, where CL comprises a major parasitic health problem (Abdellatif et al., 2013).To evaluate the efficacy of intralesional cryotherapy, intralesional Voriconazole, and oral doxycycline in the treatment of cutaneous leishmaniasis compared to the conventional treatment (intralesional SSG).

Read the detailed description
  • Cutaneous leishmaniasis is a prevalent parasitic infection in northern Africa. In Egypt, CL cases are detected mainly in eastern governorates including Sinai. Cutaneous leishmaniasis represent a socioeconomic burden on the affected communities.
  • Available treatment options are expensive and associated with systemic toxicity. There are alarming reports of emerging resistance against the currently in use therapeutics. Comparative controlled trials for the effective and the least harmful treatment modalities are lacking.
  • Up to our knowledge this is the first study investigating the effectiveness of intralesional Voriconazole and intralesional cryotherapy in the treatment of cutaneous leishmaniasis

So in this study the following objectives are being aimed:

  1. To evaluate the effectiveness and safety of intralesional Voriconazole comparing it to the intralesional SSG in patients with CL.
  2. To evaluate the effectiveness and safety of intralesional cryotherapy comparing it to the intralesional SSG in patients with CL.
  3. To evaluate the effectiveness and safety of Oral doxycycline comparing it to the intralesional SSG in patients with CL.
Being tested
Intralesional Sodium stibogluconate, Intralesional Cryotherapy, Intralesional Voriconazole, Oral doxycycline
Medical subject headings
Leishmaniasis, Cutaneous

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intralesional Sodium stibogluconateDrug

    Also called SSG

    Sessions will be held once weekly for a maximum of 6 weeks

  • Intralesional CryotherapyProcedure or surgery

    Intralesional Cryotherapy. Sessions will be held every two weeks

  • Intralesional VoriconazoleDrug

    Also called Vfend

    Weekly intralesional Voriconazole

  • Oral doxycyclineDrug

    200 mg daily for 6 weeks or till complete cure

Study groups in NCT05708625
Study groupRoleWhat they receive
Intralesional Sodium stibogluconateActive comparatorPatients will receive intralesional infiltration of (SSG) at a dose of 50 mg/0.5 ml (0.2-0.4ml) maximum dose per session 1-3 ml. Sessions will be held once weekly for a maximum of 6 weeks.
Receives: Drug: Intralesional Sodium stibogluconate
intralesional CryotherapyExperimentalPatients will be treated with intralesional Cryotherapy. Sessions will be held every two weeks till complete cure or a maximum of 6 sessions
Receives: Procedure: Intralesional Cryotherapy
Intralesional VoriconazoleExperimentalPatients will be treated with intralesional Voriconazole weekly till complete cure or a maximum of 6 sessions
Receives: Drug: Intralesional Voriconazole
Oral doxycyclineExperimentalPatients will be treated with oral doxycycline, 200 mg daily, until complete cure or a maximum of 6 weeks
Receives: Drug: Oral doxycycline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical response to treatment

    The responses will be graded by an investigator who don't perform the injections. The clinical response will be graded based on the improvement percentage of the lesion in terms of size, erythema, inflammation, edema and ulcer re-epithelialization

    Measured: 6 weeks

Secondary outcomes (2)

  1. Persistence of clinical response

    Persistence of clinical response at the end of follow-up period

    Measured: 12 week post treatment termination

  2. Patient compliance

    The percentage of patients continued the study in each arm

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Feb 2023
  2. Study start1 Jan 2022
  3. Primary completion1 Dec 2023 (estimated)
  4. Study completion1 Mar 2024 (estimated)

Resources

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
Double blind
Who is masked
Participant, Investigator
Enrolment
136 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05708625
Sponsor's protocol ID
ZU-IRB#8095/3-10-2021
Status last verified
Aug 2023
First submitted
22 Jan 2023
Last updated
29 Aug 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Akulinina IK, Berechikidze IA, Larina SN, Sakharova TV, Degtyarevskaya TY, Romanelli M. Effectiveness of doxycycline for the treatment of zoonotic cutaneous leishmaniasis in vivo. Parasitology. 2021 Mar;148(3):361-365. doi: 10.1017/S0031182020002152. Epub 2020 Nov 16.

    PubMed 33190654

  • Asilian A, Sadeghinia A, Faghihi G, Momeni A. Comparative study of the efficacy of combined cryotherapy and intralesional meglumine antimoniate (Glucantime) vs. cryotherapy and intralesional meglumine antimoniate (Glucantime) alone for the treatment of cutaneous leishmaniasis. Int J Dermatol. 2004 Apr;43(4):281-3. doi: 10.1111/j.1365-4632.2004.02002.x.

    PubMed 15090013

  • Bahrami S, Oryan A, Bemani E. Efficacy of amiodarone and voriconazole combination therapy in cutaneous leishmaniasis in the mice experimentally infected with Leishmania major. J Infect Chemother. 2021 Jul;27(7):984-990. doi: 10.1016/j.jiac.2021.02.011. Epub 2021 Feb 23.

    PubMed 33637428

  • Daie Parizi MH, Karvar M, Sharifi I, Bahrampour A, Heshmat Khah A, Rahnama Z, Baziar Z, Amiri R. The topical treatment of anthroponotic cutaneous leishmaniasis with the tincture of thioxolone plus benzoxonium chloride (Thio-Ben) along with cryotherapy: a single-blind randomized clinical trial. Dermatol Ther. 2015 May-Jun;28(3):140-6. doi: 10.1111/dth.12229. Epub 2015 Apr 6.

    PubMed 25847678

  • Soto J, Rojas E, Guzman M, Verduguez A, Nena W, Maldonado M, Cruz M, Gracia L, Villarroel D, Alavi I, Toledo J, Berman J. Intralesional antimony for single lesions of bolivian cutaneous leishmaniasis. Clin Infect Dis. 2013 May;56(9):1255-60. doi: 10.1093/cid/cit049. Epub 2013 Feb 6.

    PubMed 23390069

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Intralesional Sodium stibogluconate, Intralesional Cryotherapy and Intralesional Voriconazole in people with Leishmaniasis, Cutaneous, run by Zagazig University at 1 site in Libya.

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 5 inclusion and 10 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 29 Aug 2023. 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 Libya. 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?

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Hagar Nofal, Dr. (01006387707, hagarnofal@aucegypt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical response to treatment (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05708625, which also lists 5 linked publications.

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 29 Aug 2023; AzTrials last refreshed its copy on 8 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in