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Trial record 44 of 565 for:    applied AND irritation

A 21-Day Study to Evaluate the Skin Irritation Potential of CCP-020 (Diacerein 1%) Topical Ointment in Healthy Subjects Using a Cumulative Irritant Patch Test Design

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ClinicalTrials.gov Identifier: NCT03472534
Recruitment Status : Completed
First Posted : March 21, 2018
Last Update Posted : March 21, 2018
Sponsor:
Information provided by (Responsible Party):
Castle Creek Pharmaceuticals, LLC

Brief Summary:
Single center, randomized, controlled, evaluator blinded, within-subject comparison study to evaluate the irritation potential of CCP-020 (Diacerein 1%) topical ointment on normal skin.

Condition or disease Intervention/treatment Phase
Healthy Drug: Diacerein 1% topical ointment and Vehicle Phase 1

Detailed Description:

This is a clinical study in-humans treated with CCP-020 (Diacerein 1%) topical ointment intended to determine the cumulative irritation potential of CCP-020 (Diacerein 1%) topical ointment treatment on normal human skin in healthy volunteers using a cumulative irritancy patch test (CIPT) design.

Substances that come into contact with human skin need to be evaluated for their propensity to irritate with a reproducible, standardized, quantitative patch evaluation procedure that demonstrates the study material can be applied safely to human skin without significant risk of adverse reactions.

Cumulative irritancy patch evaluation is a modified primary irritancy test, which can detect irritants that require multiple applications to cause a skin reaction. These reactions are due to direct damage to the epidermal cells and no immunologic (allergic) mechanism is involved. This procedure may detect so-called "fatiguing substances," which are mild irritants that cause more strongly positive reactions with successive multiple skin exposure.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: A 21-Day, Randomized, Controlled Study to Evaluate the Skin Irritation Potential of CCP-020 (Diacerein 1%) Topical Ointment in Healthy Subjects Using a Cumulative Irritant Patch Test Design
Actual Study Start Date : January 9, 2018
Actual Primary Completion Date : January 30, 2018
Actual Study Completion Date : January 30, 2018

Arm Intervention/treatment
Experimental: Cohort 1 (Healthy Volunteers) Drug: Diacerein 1% topical ointment and Vehicle
CCP-020 (Diacerein 1%) topical ointment, approximately 0.2 mL, applied topically under occlusive patch conditions to the infrascapular area of the back, once daily for 21 consecutive days over 3 weeks Vehicle, approximately 0.2 mL, applied topically under occlusive patch conditions to the infrascapular area of the back, once daily for 21 consecutive days over 3 weeks
Other Name: CCP-020




Primary Outcome Measures :
  1. Skin irritation [ Time Frame: Daily for 21 days ]
    Determine the potential of CCP-020 (Diacerein 1%) topical ointment to cause skin irritation after repeated topical application to the healthy skin of humans under controlled conditions using local tolerability assessment scales.


Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: Daily for 21 days + 30 days after last product administration ]
    Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Is a healthy male or female (to be confirmed by medical history);
  • Is 18 years of age or older;
  • In the case of a female of childbearing potential, is using two acceptable forms of birth control (oral/implant/injectable/transdermal contraceptives, intrauterine device, condom with spermicide, diaphragm with spermicide, abstinence, partner's vasectomy, tubal ligation). Abstinence or vasectomies are acceptable if the female subject agrees to implement two of the other acceptable methods of birth control if her lifestyle/partner changes;
  • In the case of a female of childbearing potential, has a negative urine pregnancy test (UPT) on Day 1 prior to randomization and are willing to submit to a UPT at the end of study (EOS);
  • Is free of any systemic or dermatological disorder, which, in the opinion of the Investigator, will interfere with the study results or increase the risk of AEs;
  • Is of any Fitzpatrick Skin Type or race, providing the skin pigmentation will allow discernment of erythema

Exclusion Criteria:

  • Has any visible skin disease at the application site which, in the opinion of the Investigator, will interfere with the evaluation of the test site reaction;
  • Is using systemic/topical corticosteroids within 3 weeks prior to and/or during the study, or systemic/topical antihistamines 72 hours prior to and during the study;
  • Is not willing to refrain from using systemic/topical anti-inflammatory analgesics such as aspirin (81 mg daily aspirin will be allowed), Aleve, Motrin, Advil, or Nuprin for 72 hours prior to and during the study (occasional use of acetaminophen will be permitted);
  • Is using medication which, in the opinion of the Investigator, will interfere with the study results (e.g. anti-inflammatory medications, antipsychotics, anticonvulsants with potential pain relief effects, immunomodulatory medications, and others);
  • Is unwilling or unable to refrain from the use of sunscreens, cosmetics, creams, ointments, lotions or similar products on the back during the study;
  • Has psoriasis and/or active atopic dermatitis/eczema;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03472534


Locations
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United States, New Jersey
TKL Research
Fair Lawn, New Jersey, United States, 07410
Sponsors and Collaborators
Castle Creek Pharmaceuticals, LLC

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Responsible Party: Castle Creek Pharmaceuticals, LLC
ClinicalTrials.gov Identifier: NCT03472534     History of Changes
Other Study ID Numbers: CCP-020-102
First Posted: March 21, 2018    Key Record Dates
Last Update Posted: March 21, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Diacetylrhein
Anti-Inflammatory Agents