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Trial record 2 of 5 for:    idp 123

Study to Compare the Safety and Efficacy of IDP-123 Lotion to Tazorac Cream in the Treatment of Acne Vulgaris

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ClinicalTrials.gov Identifier: NCT02525822
Recruitment Status : Unknown
Verified September 2015 by Valeant Pharmaceuticals.
Recruitment status was:  Not yet recruiting
First Posted : August 17, 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 safety and efficacy of once daily application of IDP-123 Lotion to Tazorac Cream, 0.1%, Vehicle Lotion, and Vehicle Cream in subjects with moderate to severe acne vulgaris.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: IDP-123 Lotion Drug: Tazorac Cream, 0.1%, Drug: Vehicle Cream Drug: Vehicle Lotion 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-123 Lotion in comparison with Tazorac Cream, Vehicle Lotion, and Vehicle Cream in subjects with moderate to severe acne. Treatment success will be evaluated by changes in inflammatory and non-inflammatory lesion counts, as well as treatment success using an Evaluator's Global Severity Score. IDP-123 is a lotion for the topical treatment of acne.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study to Compare the Safety and Efficacy of IDP-123 Lotion to Tazorac® (Tazarotene) Cream, 0.1%, in the Treatment of Acne Vulgaris
Study Start Date : September 2015
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne
Drug Information available for: Tazarotene
U.S. FDA Resources

Arm Intervention/treatment
Experimental: IDP-123 Lotion
IDP-123 Lotion, applied topically to the face, once daily for 12 weeks.
Drug: IDP-123 Lotion
Investigational Product: IDP-123 Lotion
Active Comparator: Tazorac Cream, 0.1%
Tazorac Cream (tazarotene 0.1%), applied topically to the face, once daily for 12 weeks.
Drug: Tazorac Cream, 0.1%,
Comparator Product: Tazorac Cream, 0.1%
Other Name: tazarotene
Placebo Comparator: Vehicle Cream
Vehicle Cream, applied topically to the face, once daily for 12 weeks.
Drug: Vehicle Cream
Comparator Product: Vehicle Cream
Placebo Comparator: Vehicle Lotion
Vehicle Lotion, applied topically to the face, once daily for 12 weeks.
Drug: Vehicle Lotion
Comparator Product: Vehicle Lotion



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

    Facial area lesion counts will be taken from the subject's face by the Evaluator at each visit and the change at week 12 from baseline will be calculated. Facial inflammatory lesions (pustules, papules, and nodules) will be counted as follows: pustules and papules will be counted and recorded together, not separately; nodular lesions will be counted and recorded separately.

    Inflammatory lesions are defined as follows:

    Papule - a solid, elevated lesion less than 5 mm; Pustule - an elevated lesion containing pus less than 5 mm; Nodule - palpable subcutaneous lesion greater than 5 mm; has depth, not necessarily elevated


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

    Facial area lesion counts will be taken from the subject's face by the Evaluator at each visit, and the change at week 12 from baseline will be calculated. Non-inflammatory lesions (open and closed comedones) will be counted and recorded together.

    Non-inflammatory lesions are defined as follows:

    Open comedones (blackhead) - plugged hair follicle with dilated/open orifice, black in color; Closed comedones (whitehead) - plugged hair follicle: small opening at skin surface


  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
    2. Mild- Some non-inflammatory lesions are present, with few inflammatory lesions (papules/pustules only; no nodulocystic 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 nodulocystic lesion
    4. Severe- Inflammatory lesions are more apparent, many comedones and papules/pustules, there may or may not be up to 2 nodulocystic lesions.


Secondary Outcome Measures :
  1. Mean percent change in inflammatory lesion count from 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 lesions (papules, pustules, and nodules) on the subject's face, and the percent change will be calculated.

  2. Mean percent change in non-inflammatory lesion counts from 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 non-inflammatory lesions (open and closed comedones), and the percent change will be calculated.

  3. The proportion of subjects with at least a two grade improvement in the Evaluator's Global Severity Score from baseline at Weeks 2, 4, 8 and 12. [ Time Frame: 2, 4, 8, and 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 nodulocystic 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 nodulocystic lesion
    4. Severe- Inflammatory lesions are more apparent, many comedones and papules/pustules, there may or may not be up to 2 nodulocystic lesions.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female at least 12 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
  • Pre-menses females and women of childbearing potential must have a negative urine pregnancy test at the 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 subjects 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): NCT02525822


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: NCT02525822     History of Changes
Other Study ID Numbers: V01-123A-201
First Posted: August 17, 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
Tazarotene
Nicotinic Acids
Dermatologic Agents
Keratolytic Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs