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RosaceaPhase 1NCT06557603

Bioequivalence Study of Ivermectin 1% Cream and Soolantra (Ivermectin) 10 mg/g Cream

A Phase 1 study testing Ivermectin cream and Soolantra ® (Ivermectin) cream in people with Rosacea, run by Humanis Saglık Anonim Sirketi at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Single dose bioequivalence study of Ivermectin 1% cream and Soolantra (Ivermectin) 10 mg/g cream in healthy adult human subjects. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Rosacea
What is being tested?
Ivermectin cream and Soolantra ® (Ivermectin) cream
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteIndia
Study dates
6 Mar 2024to 22 Jul 2024
Phase
Phase 1
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 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Age: 18 to 45 years old, both inclusive.
  • Gender: Male and/or non-pregnant, non-lactating female. A. Female of childbearing potential had a negative serum beta human chorionic gonadotropin (β-HCG) pregnancy test performed within 28 days prior to first cream application day. They has used an acceptable form of contraception.
  • For female of childbearing potential, acceptable forms of contraception included the following:
  • Non hormonal intrauterine device in place for at least 3 months prior to the start of the study and remaining in place during the study period, or ii. Barrier methods containing or used in conjunction with a spermicidal agent, or iii. Surgical sterilization or iv. Practicing sexual abstinence throughout the course of the study.
  • Female was not considered of childbearing potential if one of the following was reported and documented on the medical history:
  • Postmenopausal with spontaneous amenorrhea for at least one year, or ii. Bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or iii. Total hysterectomy and an absence of bleeding for at least 3 months.
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  • BMI: 18.5 to 30.0 kg/m2, both inclusive; BMI value were rounded off to one significant digit after decimal point (e.g. 30.04 rounded down to 30.0, while 18.45 rounded up to 18.5).
  • Volunteer having weight ≥ 50 Kg.
  • The Volunteers were able to communicate effectively with study personnel.
  • The Volunteers willing to provide written informed consent to participate in the study.
  • All volunteers were judged by the principal or sub-investigator or physician as normal and healthy during a pre-study safety assessment performed within 28 days of the first dose of cream application which included:
  • A physical examination (clinical examination) with no clinically significant finding.

Who cannot join

  • Volunteers who met any one of the following criteria were not enrolled in the study.
  • History of allergic responses to Ivermectin or other related drugs, or any of its formulation ingredients.
  • Female subjects of childbearing potential had unprotected sexual intercourse with any non-sterile male partner (i.e. male who was not sterilized by vasectomy for at least 6 months) within 14 days prior to the first dose of cream application.
  • Currently pregnant, lactating or breast-feeding (for female volunteers).
  • Use of oral contraceptives within 30 days prior to the first dose of cream application (for female volunteers).
  • Had significant diseases or clinically significant abnormal findings during screening [medical history, physical examination (clinical examination), laboratory evaluations, ECG recording, gynecological history and examination (including pelvic examination and routine breast examination) (for female volunteers)].
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  • Any disease or condition like diabetes, psychosis or others, which compromised the haemopoietic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system or any other body system.
  • History or presence of bronchial asthma.
  • Use of any hormone replacement therapy within 3 months prior to the first dose of cream application.
  • A depot injection or implant of any drug within 3 months prior to the first dose of cream application.
  • Use of CYP enzyme inhibitors or inducers within 30 days prior to the first dose of cream application.
  • History or evidence of drug dependence or of alcoholism or of moderate alcohol use.
  • Smokers who smoked 10 or more cigarettes per day or 20 or more biddies per day or those who could not refrained from smoking during the study period.
  • History of difficulty with donating blood or difficulty in accessibility of veins.
  • A positive hepatitis screen (includes subtypes B \& C).
  • A positive test result for HIV antibody.
  • Volunteers who had received a known investigational drug within seven elimination half life of the administered drug prior to the first dose of cream application.
  • Volunteers who had donated blood or loss of blood 50 ml to 100 ml within 30 days or 101 ml to 200 ml within 60 days or >200 ml within 90 days (excluding volume drawn at screening for this study) prior to first dose of cream application, whichever was greater.
  • Sitting systolic blood pressure less than 100 mmHg or greater than 140 mmHg or sitting diastolic blood pressure less than 60 mmHg or greater than 90 mmHg and pulse rate less than 60 or greater than 100 beats per minute during screening.
  • Illness within 14 days before the start of the study.
  • Hospitalisation within 3 months before the start of the study (at the discretion of the Investigator).
  • Intolerance to venipuncture.
  • Any food allergy, intolerance, restriction or special diet that, in the opinion of the principal investigator or sub-investigator, contraindicated the volunteer's participation in this study.
  • Institutionalized volunteers.
  • Use of any prescribed medications within 14 days prior to the first dose of cream application.
  • Use of any OTC products, vitamin and herbal products, etc., within 7 days prior to the first dose of cream application.
  • Use of grapefruit and grapefruit containing products within 7 days prior to the first dose of cream application.
  • Ingestion of any caffeine or xanthine products (i.e. coffee, tea, chocolate, and caffeinecontaining sodas, colas, etc.), cigarettes and tobacco containing products, recreational drugs, alcohol or other alcohol containing products within 48 hours prior to the first dose of cream application.
  • Ingestion of any unusual diet, for whatever reason (e.g.: low sodium) for three weeks prior to the first dose of cream application.
  • Volunteer has tattoo, mark of injury/surgery, any discolouration of skin, any ongoing skin disease or history of frequent skin disease, damaged skin at application sites or has cracks/hardening/scarring at the application site.
  • Presence of open sores, or other skin abnormalities at the application site.
  • History of cryodestruction or chemodestruction, dermabrasion, photodynamic therapy, intralesional steroids within one month.

Trial locations and contacts

1 site in 1 country.

India1 site

  • Cliantha Research Limited

    Vadodara, Gujarat, 390012

Other trials in India

About this study

Official title: Single Dose Bioequivalence Study of Ivermectin 1% Cream and Soolantra (Ivermectin) 10 mg/g Cream in Healthy Adult Human Subjects

Single dose bioequivalence study of Ivermectin 1% cream and Soolantra (Ivermectin) 10 mg/g cream in healthy adult human subjects.

Read the detailed description

An open label, randomized, four-period, two treatment, two-sequence, fully replicate, crossover, balanced, single dose bioequivalence study.

Conditions
Rosacea
Being tested
Ivermectin cream, Soolantra ® (Ivermectin) cream
Medical subject headings
Rosacea

What participants receive

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

  • Ivermectin creamDrug

    [1 gm ± 0.030 gm] of product was applied in a thin layer over the entire face (avoiding the eyes, lips, and mucous membranes).

  • Soolantra ® (Ivermectin) creamDrug

    [1 gm ± 0.030 gm] of product was applied in a thin layer over the entire face (avoiding the eyes, lips, and mucous membranes).

Study groups in NCT06557603
Study groupRoleWhat they receive
Ivermectin creamExperimentalIvermectin 1% cream
Receives: Drug: Ivermectin cream; Drug: Soolantra ® (Ivermectin) cream
Soolantra (Ivermectin) creamActive comparatorSoolantra (Ivermectin) 10 mg/g cream
Receives: Drug: Ivermectin cream; Drug: Soolantra ® (Ivermectin) cream

What is being measured

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

  1. Maximum measured plasma concentration (Cmax)

    If the reference product intra-subject CV is less than or equal to 30% for Cmax, then the 90% confidence interval of the relative mean Cmax of the test to reference formulation for Ln-transformed data was to be within 80.00% to 125.00%.

    Measured: 21 hours

  2. Area under the plasma concentration versus time curve from the time zero time point to the last quantifiable concentration (AUCt)

    The 90% confidence interval of the relative mean (Geometric mean) of the Test to reference formulation for Ln-transformed AUCt was to be within 80.00% to 125.00%

    Measured: 21 hours

Secondary outcomes (2)

  1. Area under the plasma concentration versus time curve from time zero to infinity (AUCi)

    Descriptive statistic

    Measured: 21 hours

  2. Time of the maximum measured plasma concentration (Tmax)

    Descriptive statistic

    Measured: 21 hours

Timeline

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

  1. First posted16 Aug 2024
  2. Study start6 Mar 2024
  3. Primary completion11 Jul 2024
  4. Study completion22 Jul 2024

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 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06557603
Sponsor's protocol ID
C1B01784
Status last verified
Aug 2024
First submitted
14 Aug 2024
Last updated
20 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ivermectin cream and Soolantra ® (Ivermectin) cream in people with Rosacea, run by Humanis Saglık Anonim Sirketi at 1 site in India.

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 12 inclusion and 32 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: finished, as of the sponsor's last update on 20 Aug 2024. 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 India. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Maximum measured plasma concentration (Cmax) (time frame: 21 hours). The study lists 2 primary outcomes in all. 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 NCT06557603.

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 Aug 2024.

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