A Single-Centre Open-label Pharmacology Study of Topically Applied MTC896 Gel in Healthy Volunteers.

A Single-Centre Open-label Pharmacology Study of Topically Applied MTC896 Gel in Healthy Volunteers

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12617000498392

Enrollment

Registered

2017-04-06

Start date

2017-05-03

Completion date

2017-05-17

Last updated

2017-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study is designed to investigate the pharmacology of MTC896 Gel in otherwise healthy female participants with oily skin. In this study, MTC896 Gel will be applied at 1 concentration, twice daily (bid) for 4 weeks to the postauricular region (behind the ear) a region known to be rich in sebaceous glands. Participants will be required to administer study drug at home, other than when applications coincide with study outpatient visits. All participants will be required to attend a screening visit, at which skin oilyness will be measured with a Sebumeter (a non-invasive skin probe), If participants are deemed eligible for the study, a small biopsy will be collected from the post auricular region. Study participants will be shown how to administer study drug, and will be discharged with study medication for home dosing. Participants will be asked to record their doses and any symptoms in a diary during the 28 day follow up period. Participants will be asked to return for an outpatient visit after 14 days, then a final follow up visit at 28 days. At the final follow up visit a second biopsy sample will be collected from the post-auricular region, and sebum (oil) levels will be evaluated with a sebumeter. It is hoped that the results of this study will provide evidence that MCL16001 is able to reduce skin oiliness, and may therefore be useful in the prevention and treatment of acne.

Interventions

Study participants will self-administer study drug (MTC896 gel - 1.5% w/w active ingredient) twice daily for 28 days. The study drug will be applied topically to the skin of the postauricular region from a single use tube containing 0.5 mL MCL896 gel in the morning and evening.. Participants will be required to complete a diary recording details of study drug administration.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 40 Years

Healthy volunteers

Yes

Inclusion criteria

* Generally healthy, non-pregnant females * Has oily skin, as measured by a Sebumeter at screening (> or = to 150 ug/cm2/h) in the periauricular region).

Exclusion criteria

* Pregnancy * Skin conditions that would interfere with assessments (e.g. rosacea, acne, dermatitis). * Recent use of oral retinoids of Vitamin A supplements.

Outcome results