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A Study Comparing the Efficacy and Safety of IDP-120 Gel in the Treatment of Acne Vulgaris

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ClinicalTrials.gov Identifier: NCT02537483
Recruitment Status : Unknown
Verified September 2015 by Valeant Pharmaceuticals.
Recruitment status was:  Not yet recruiting
First Posted : September 1, 2015
Last Update Posted : September 14, 2015
Sponsor:
Information provided by (Responsible Party):
Valeant Pharmaceuticals

Brief Summary:
The primary objective of this study is to compare the efficacy, safety, and tolerability of IDP-120 Gel to IDP-120 Component A, IDP-120 Component B, and IDP-120 Vehicle Gel in subjects with moderate to severe acne vulgaris.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: IDP-120 Gel Drug: IDP-120 Component A Drug: IDP-120 Component B Drug: IDP-120 Vehicle Gel Phase 2

Detailed Description:
This is a multi-center, randomized, double-blind, vehicle-controlled, 12-week study designed to assess the safety, tolerability, and efficacy of IDP-120 Gel in comparison with IDP-120 Component A, IDP-120 Component B, and IDP-120 Vehicle Gel at Weeks 2, 4, 8, and 12 in subjects with moderate to severe acne. IDP-120 is a gel for the topical treatment of acne.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, Parallel-Group, Clinical Study Comparing the Efficacy and Safety of IDP-120 Gel in the Treatment of Acne Vulgaris
Study Start Date : October 2015
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Experimental: IDP-120 Gel
IDP-120 Gel, applied topically to the face once daily for 12 weeks.
Drug: IDP-120 Gel
Investigational Product: IDP-120 Gel

Active Comparator: IDP-120 Component A
IDP-120 Component A, applied topically to the face once daily for 12 weeks
Drug: IDP-120 Component A
Comparator Product: IDP-120 Component A

Active Comparator: IDP-120 Component B
IDP-120 Component B, applied topically to the face once daily for 12 weeks
Drug: IDP-120 Component B
Comparator Product: IDP-120 Component B

Placebo Comparator: IDP-120 Vehicle Gel
IDP-120 Vehicle Gel, applied topically to the face once daily for 12 weeks
Drug: IDP-120 Vehicle Gel
Comparator Product: IDP-120 Vehicle Lotion




Primary Outcome Measures :
  1. Absolute change from Baseline to Week 12 in mean inflammatory lesion counts [ Time Frame: 12 weeks ]

    At each visit the Evaluator will count the total number of inflammatory lesions (papules, pustules, and nodules) on the subject's face.

    Inflammatory lesions are defined as follows:

    Papule - a small, solid elevation less than 5 mm in diameter. Most of the lesion is above the surface of the skin.

    Pustule - a small, circumscribed elevation less than 5 mm in diameter that contains yellow-white exudate.

    Nodule - a subcutaneous lesion greater than or equal to 5 mm in diameter.


  2. Absolute change from Baseline to Week 12 in mean non-inflammatory lesion counts [ Time Frame: 12 weeks ]

    At each visit the Evaluator will count the total number of non-inflammatory lesions (open and closed comedones).

    Non-inflammatory lesions are defined as follows:

    Open comedones (black head) - a lesion in which the follicle opening is widely dilated with the contents protruding out onto the surface of the skin.

    Closed comedones (white head)- a lesion in which the follicle opening is closed, but the sebaceous gland is enlarged by the pressure of the sebum build up, which in turn causes the skin around the follicle to thin and become elevated with a white appearance.


  3. Percent of subjects who achieve at least a two-grade reduction from baseline and are Clear or Almost Clear at Week 12 in the Evaluator's Global Severity Score. [ Time Frame: 12 weeks ]

    At each visit the severity will be determined based on evaluator-blinded evaluations of the signs and symptoms of acne vulgaris. Evaluations will be scored on a scale of 0-4 (Evaluator's Global Severity Score), with 0 being clear and 4 being severe. Please see below for complete definitions.

    0. Clear - Normal, clear skin with no evidence of acne vulgaris

    1. Almost clear- Rare non-inflammatory lesions present, with rare non-inflamed papules (papules must be resolving and may be hyperpigmented, though not pink-red)
    2. Mild- Some non-inflammatory lesions are present, with few inflammatory lesions (papules/pustules only; no nodulo-cystic lesions)
    3. Moderate-Non-inflammatory lesions predominate, with multiple inflammatory lesions evident: several to many comedones and papules/pustules, and there may or may not be one nodulo-cystic lesion
    4. Severe- Inflammatory lesions are more apparent, many comedones and papules/pustules, there may or may not be up to 2 nodulo-cystic lesions.


Secondary Outcome Measures :
  1. Absolute change in inflammatory and non-inflammatory lesion counts from baseline at Weeks 2, 4, and 8. [ Time Frame: 2, 4, and 8 weeks ]
    At each visit the Evaluator will count the total number of inflammatory (papules, pustules, and nodules) and non-inflammatory (open and closed comedones) lesions on the subject's face, and the change will be calculated.

  2. Percent of subjects who achieve at least a two-grade reduction from baseline and are Clear or Almost Clear at Week 2, 4, and 8 in the Evaluator's Global Severity Score [ Time Frame: 2, 4, and 8 weeks ]

    At each visit the severity will be determined based on evaluator-blinded evaluations of the signs and symptoms of acne vulgaris. Evaluations will be scored on a scale of 0-4 (Evaluator's Global Severity Score), with 0 being clear and 4 being severe. Please see below for complete definitions.

    0. Clear - Normal, clear skin with no evidence of acne vulgaris

    1. Almost clear- Rare non-inflammatory lesions present, with rare non-inflamed papules (papules must be resolving and may be hyperpigmented, though not pink-red)
    2. Mild- Some non-inflammatory lesions are present, with few inflammatory lesions (papules/pustules only; no nodulo-cystic lesions)
    3. Moderate-Non-inflammatory lesions predominate, with multiple inflammatory lesions evident: several to many comedones and papules/pustules, and there may or may not be one nodulo-cystic lesion
    4. Severe- Inflammatory lesions are more apparent, many comedones and papules/pustules, there may or may not be up to 2 nodulo-cystic lesions.

  3. Mean percent change in inflammatory and non-inflammatory lesion counts form baseline at Weeks 2, 4, 8, and 12. [ Time Frame: 2, 4, 8, and 12 weeks ]
    At each visit the Evaluator will count the total number of inflammatory (papules, pustules, and nodules) and non-inflammatory (open and closed comedones) lesions on the subject's face, and the percent change will be calculated.



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Ages Eligible for Study:   9 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female at least 9 years of age and older
  • Written and verbal informed consent must be obtained.
  • Subject must have a score of moderate or severe on the Evaluator's Global Severity assessment at the screening and baseline visit
  • Pre-menses females and women of childbearing potential must have a negative urine pregnancy test at screening and baseline visits
  • Subjects must be willing to comply with study instructions and return to the clinic for required visits.

Exclusion Criteria:

  • Any dermatological conditions on the face that could interfere with clinical evaluations
  • Any underlying disease(s) or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion count inconclusive
  • Subjects with a facial beard or mustache that could interfere with the study assessments
  • Subjects who are unable to communicate or cooperate with the Investigator
  • Subjects with any underlying disease that the Investigator deems uncontrolled and poses a concern for the subject's safety while participating in the study

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): NCT02537483


Contacts
Contact: Anya Loncaric, MS 510-259-5284 aloncaric@solta.com

Sponsors and Collaborators
Valeant Pharmaceuticals
Investigators
Study Director: Anya Loncaric, MS Valeant Pharmaceuticals

Responsible Party: Valeant Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02537483     History of Changes
Other Study ID Numbers: V01-120A-201
First Posted: September 1, 2015    Key Record Dates
Last Update Posted: September 14, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases