---
title: Skin Safety Study to Evaluate the Irritation Potential in Healthy Volunteers
nct_id: NCT02227069
overall_status: COMPLETED
phase: PHASE1
sponsor: Maruho North America Inc.
study_type: INTERVENTIONAL
primary_condition: Healthy Volunteers
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02227069.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02227069"
ct_last_update_post_date: 2015-03-30
last_seen_at: "2026-05-12T07:05:28.918Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Skin Safety Study to Evaluate the Irritation Potential in Healthy Volunteers

**Official Title:** A Phase 1, 21-Day, Randomized, Evaluator Blinded, Controlled Study to Evaluate the Irritation Potential of M518101 in Healthy Volunteers, Using a Cumulative Irritant Patch Test Design

**NCT ID:** [NCT02227069](https://clinicaltrials.gov/study/NCT02227069)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 30
- **Lead Sponsor:** Maruho North America Inc.
- **Conditions:** Healthy Volunteers
- **Start Date:** 2014-09
- **Completion Date:** 2015-03
- **CT.gov Last Update:** 2015-03-30

## Brief Summary

This is a single center, randomized, controlled, within-subject comparison, multiple dose study to determine the irritation potential of M518101 on normal skin under occlusive patch condition.

The study drug will be applied for 21 days under occlusive patch condition. The irritation potential of M518101 will be compared with positive, negative control and M518101 vehicle. The study duration is 21days and there will be at least 23 visits to study center including screening visit.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

* Health male or female subjects age 18 years or older
* Signed and dated Informed Consent Form obtained prior to any study-related activities
* Subjects are free of any systemic or dermatologic disorder
* For Female, females of non-childbearing potential or who agree to use a highly effective method of birth control during the study and have a negative urine pregnancy test.
* Subjects must be able to communicate with the investigator and understand and comply with the requirements of the study and visit schedule

Exclusion Criteria:

* Have any visible skin disease at the application site which will interfere with the evaluation of the test site reaction
* Have damaged skin in or around the test sites
* Have a history of sensitivity to adhesive tape
* Have a known sensitivity to constituents present in the material being evaluated
* Have a history of, or are currently being treated for skin cancer
* have used any study drug and/or participate in any clinical study within 60 days prior to Randomization
* to engage in any type of strenuous exercise (swimming, running, etc.) or who intended to use hot tubs or saunas during the study
* Are pregnant, breastfeeding, or of childbearing potential and who wish to become pregnant during the study
* Are deemed to be ineligible by the investigator
```

## Arms

- **M518101** (EXPERIMENTAL) — M518101 is applied topically under occlusive patch conditions to the infrascapular area of the back, once daily for 21 consecutive days over 3 weeks
- **M518101 Vehicle** (PLACEBO_COMPARATOR) — M518101 vehicle is applied topically under occlusive patch conditions to the infrascapular area of the back, once daily for 21 consecutive days over 3 weeks
- **sodium lauryl sulfate** (ACTIVE_COMPARATOR) — A solution of 0.2% sodium lauryl sulfate is applied topically under occlusive patch conditions to the infrascapular area of the back once daily for 21 days over 3 weeks, will serve as a positive control.
- **Saline** (SHAM_COMPARATOR) — A solution of 0.9% saline is applied topically under occlusive patch conditions to the infrascapular area of the back once daily for 21 days over 3 weeks, will serve as a negative control.

## Interventions

- **M518101** (DRUG)
- **M518101 Vehicle** (DRUG)
- **sodium lauryl sulfate** (OTHER)
- **saline** (OTHER)

## Primary Outcomes

- **Inflammatory skin responses** _(time frame: 21 Days)_ — Drug application sites will be evaluated for signs of inflammatory skin responses (e.g. erythema, edema, papules) and superficial effects.

## Locations (1)

- TKL research, Fair Lawn, New Jersey, United States

## Recent Field Changes (last 30 days)

- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.tkl research|fair lawn|new jersey|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT02227069.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT02227069*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*