Acne VulgarisEarly Phase 1NCT03090048
Vitamin A and Azithromycin for Acne Vulgaris
A Early Phase 1 study testing Vitamin A and Azithromycin in people with Acne Vulgaris, run by Manchanda Medical Clinic at 1 site in Canada.
Trial summary
Patients seen with acne lesions not having responded to existing treatments will be offered a placebo or a topical preparation consisting of Vitamin A USP with or without Azithromycin for a duration of 4-6 months USP for the objective of resolving the lesions without systemic side effects and via weekly follow-ups. Read more about this study
- Who is it for?
- Ages 12 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Vitamin A and Azithromycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 1 Apr 2021to 31 Oct 2021
- Phase
- Early 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 12 to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients with active lesions
Who cannot join
- Patients on a treatment
- Asymptomatic patients
Trial locations and contacts
1 site in 1 country.
Canada1 site
Manchanda Mc
Surrey, British Columbia, V3W2T2
VINOD TAWAR, MD, 604 754 2235, TAWAR.VINOD@YAHOO.COM
About this study
Official title: Treatment of Acne for Cases Resistant to Currently Available Measures Via Vitamin A With or Without Azithromycin in Topical Formulations
Patients seen with acne lesions not having responded to existing treatments will be offered a placebo or a topical preparation consisting of Vitamin A USP with or without Azithromycin for a duration of 4-6 months USP for the objective of resolving the lesions without systemic side effects and via weekly follow-ups.
Read the detailed description
The concentrations of the active ingredients is based on the enclosed articles and the formulations have been modified with an objective of minimizing the side effects.
- Conditions
- Acne Vulgaris
- Being tested
- Vitamin A, Azithromycin
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin ADrug
Also called retinyl palmitate
Vitamin A 2-3 % concentration
AzithromycinDrug
Also called azithromycin monohydrate
azithromycin monohydrate
| Study group | Role | What they receive |
|---|---|---|
| Vitamin A | Experimental | retinyl palmitate USP Receives: Drug: Vitamin A |
| Azithromycin with Vitamin A | Experimental | USP grade ingredients Receives: Drug: Vitamin A; Drug: Azithromycin |
| Azithromycin | Active comparator | azithromycin monohydrate Receives: Drug: Azithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement (dimensions) of acne lesions
follow-up focussed on observation of changes
Measured: Every 4 weeks up to16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2017
- Study start1 Apr 2021 (estimated)
- Primary completion24 Aug 2021 (estimated)
- Study completion31 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acne VulgarisStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Manchanda Medical Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DR. VINOD C TAWAR, Manchanda Medical Clinic
- Investigators
- Vinod C Tawar, Study director, M.D.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03090048
- Sponsor's protocol ID
- Tawar -1
- Status last verified
- Feb 2021
- First submitted
- 29 Jan 2017
- Last updated
- 25 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Bartlett KB, Davis SA, Feldman SR. Tolerability of topical antimicrobials in treatment of acne vulgaris. J Drugs Dermatol. 2014 Jun;13(6):658-62.
PubMed 24918554
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Acne for Cases Resistant to Currently Available Measures Via Vitamin A With or Without Azithromycin in Topical Formulations
- ClinicalTrials.gov ID
- NCT03090048
- Acronym / sponsor ID
- Tawar -1
- Conditions
- Acne Vulgaris
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Manchanda Medical ClinicUniversity, hospital or other
- Study start
- 1 Apr 2021 (estimated)
- Primary completion
- 24 Aug 2021 (estimated)
- Study completion
- 31 Oct 2021 (estimated)
- First posted
- 24 Mar 2017 (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.
Patients seen with acne lesions not having responded to existing treatments will be offered a placebo or a topical preparation consisting of Vitamin A USP with or without Azithromycin for a duration of 4-6 months USP for the objective of resolving the lesions without systemic side effects and via weekly follow-ups.
Detailed description
The concentrations of the active ingredients is based on the enclosed articles and the formulations have been modified with an objective of minimizing the side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vitamin A | Experimental | Drug: Vitamin Aretinyl palmitate USP |
| Azithromycin with Vitamin A | Experimental | Drug: Vitamin A, Drug: AzithromycinUSP grade ingredients |
| Azithromycin | Active comparator | Drug: Azithromycinazithromycin monohydrate |
Who may qualify
- Ages
- 12 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients with active lesions
Key exclusion criteria (2 listed)
- Patients on a treatment
- Asymptomatic patients
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 |
|---|---|---|
| Vitamin AAlso: retinyl palmitateVitamin A 2-3 % concentration | Drug | Azithromycin with Vitamin A, Vitamin A |
| AzithromycinAlso: azithromycin monohydrateazithromycin monohydrate | Drug | Azithromycin, Azithromycin with Vitamin A |
Primary outcome
Measurement (dimensions) of acne lesions
Time frame: Every 4 weeks up to16 weeks
follow-up focussed on observation of changes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2021.
- Results publication: PubMed 24918554Bartlett KB, Davis SA, Feldman SR. Tolerability of topical antimicrobials in treatment of acne vulgaris. J Drugs Dermatol. 2014 Jun;13(6):658-62.
- Individual participant dataSharing planned: Yes
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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.
Vinod C Tawar study director
M.D.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Vitamin A and Azithromycin in people with Acne Vulgaris, run by Manchanda Medical Clinic at 1 site in Canada.
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 1 inclusion and 2 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 25 Feb 2021. 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 Canada. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Vinod C Tawar, M.Sc., M.D. (604 754 2235, Tawar.vinod@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement (dimensions) of acne lesions (time frame: Every 4 weeks up to16 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 NCT03090048, which also lists 1 linked publication.
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 25 Feb 2021.