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A Clinical Trial to Evaluate the Efficacy of Two Acne Treatments

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ClinicalTrials.gov Identifier: NCT02755545
Recruitment Status : Completed
First Posted : April 29, 2016
Last Update Posted : August 2, 2017
Sponsor:
Information provided by (Responsible Party):
Galderma Laboratories, L.P.

Brief Summary:

The purpose of this study is to evaluate the efficacy of 2 acne treatments for 24 weeks of use in adult men and women with mild to moderate facial acne, at least 5 inflammatory lesions, and at least 10 - 100 non-inflammatory lesions.

Objective:

  1. To characterize the effectiveness of the acne treatment in lesion count at week 1, week 2, week 6, week 12, and week 24 as compared to baseline and compare between treatments
  2. To characterize the effectiveness of the acne treatment in Investigator's Global Improvement Assessment at week 1, week 2, week 6, week 12, and week 24 as compared to baseline and compare between treatments
  3. To characterize the effect of the acne treatment in clinical grading of efficacy parameters through digital images at week 6, week 12, and week 24 as compared to baseline and compare between treatments
  4. To characterize the effect of the acne treatment in subject self-assessment questionnaire responses at week 1, week 2, week 6, week 12, and week 24 as compared to baseline and compare between treatments

Condition or disease Intervention/treatment Phase
Acne Drug: Product A (adapalene) Drug: Product B (salicylic acid) Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 127 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multi-Center Clinical Trial to Evaluate the Efficacy of Two Acne Treatments
Actual Study Start Date : May 1, 2016
Actual Primary Completion Date : April 4, 2017
Actual Study Completion Date : April 4, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Active Comparator: Product A (adapalene)
Product A applied topically to the entire face or other affected area of the skin once daily
Drug: Product A (adapalene)
Product A applied topically to the entire face or other affected area of the skin once daily

Active Comparator: Product B (salicylic acid)
Product B applied topically to the affected area of the skin 1 to 3 times daily.
Drug: Product B (salicylic acid)
Product B applied topically to affected area of the skin 1 to 3 times daily




Primary Outcome Measures :
  1. Percent change in total lesions at Week 12 from baseline [ Time Frame: 12 weeks ]
    Percent change from baseline assessment at week 12 as assessed by investigator or designee.


Secondary Outcome Measures :
  1. Mean change in inflammatory lesion count [ Time Frame: Week 1, Week 2, Week 6, Week 12, Week 18, Week 24 ]

    Mean change from baseline assessments at Week 1, Week 2, Week 6, Week 12, Week 18, and Week 24 as assessed by investigator or designee.

    Note that papules and pustules are classified as inflammatory acne lesions.


  2. Mean change in non-inflammatory lesion count [ Time Frame: Week 1, Week 2, Week 6, Week 12, Week 18, Week 24 ]

    Mean change from baseline assessments at Week 1, Week 2, Week 6, Week 12, Week 18, and Week 24 as assessed by investigator or designee.

    Note that open and closed comedones are classified as non-inflammatory acne lesions.


  3. Mean Change in Investigator's Global Assessment (IGA) [ Time Frame: Week 1, Week 2, Week 6, Week 12, Week 18, Week 24 ]
    Mean change from baseline assessments at Week 1, Week 2, Week 6, Week 12, Week 18, and Week 24 as assessed by investigator or designee using the IGA scale (0=Clear; 1=Almost Clear; 2=Mild; 3=Moderate; 4=Severe).

  4. Mean change in skin texture (digital images) [ Time Frame: Week 6, Week 12, Week 24 ]

    Mean change from baseline efficacy parameter assessment at Week 6, Week 12, and Week 24 as assessed by trained evaluator. The efficacy parameter will be assessed globally using a modified Griffiths' 10-point scale according to the following numerical definitions (half-point scores may be used as necessary to more accurately describe the skin condition):

    0 = none (best possible condition); 1 to 3 = mild; 4 to 6 = moderate; 7 to 9 = severe (worst possible condition)


  5. Mean change in skin tone evenness (digital images) [ Time Frame: Week 6, Week 12, Week 24 ]

    Mean change from baseline efficacy parameter assessment at Week 6, Week 12, and Week 24 as assessed by trained evaluator. The efficacy parameter will be assessed globally using a modified Griffiths' 10-point scale according to the following numerical definitions (half-point scores may be used as necessary to more accurately describe the skin condition):

    0 = none (best possible condition); 1 to 3 = mild; 4 to 6 = moderate; 7 to 9 = severe (worst possible condition)


  6. Mean change in skin clarity (digital images) [ Time Frame: Week 6, Week 12, Week 24 ]

    Mean change from baseline efficacy parameter assessment at Week 6, Week 12, and Week 24 as assessed by trained evaluator. The efficacy parameter will be assessed globally using a modified Griffiths' 10-point scale according to the following numerical definitions (half-point scores may be used as necessary to more accurately describe the skin condition):

    0 = none (best possible condition); 1 to 3 = mild; 4 to 6 = moderate; 7 to 9 = severe (worst possible condition)


  7. Mean change in overall skin complexion (digital images) [ Time Frame: Week 6, Week 12, Week 24 ]

    Mean change from baseline efficacy parameter assessment at Week 6, Week 12, and Week 24 as assessed by trained evaluator. The efficacy parameter will be assessed globally using a modified Griffiths' 10-point scale according to the following numerical definitions (half-point scores may be used as necessary to more accurately describe the skin condition):

    0 = none (best possible condition); 1 to 3 = mild; 4 to 6 = moderate; 7 to 9 = severe (worst possible condition)


  8. Subject self-assessment questionnaire [ Time Frame: Week 1, Week 2, Week 6, Week 12, Week 24 ]
    Subjects will be asked to complete a self-assessment questionnaire at Week 1, Week 2, Week 6, Week 12, and Week 24. This questionnaire has a 5-point Likert Response Scale (1=Strongly Agree; 5=Strongly Disagree).

  9. Incidence of Adverse Events [ Time Frame: 24 weeks ]
  10. Mean change in erythema (tolerance) parameter [ Time Frame: Baseline, Week 1, Week 2, Week 6, Week 12, Week 24 ]
    Investigator-reported erythema evaluations will be performed at baseline and weeks 1, 2, 6, 12, and 24 using a 4 point scale (0=None; 3=Severe).

  11. Mean change in dryness (tolerance) parameter [ Time Frame: Baseline, Week 1, Week 2, Week 6, Week 12, Week 24 ]
    Investigator-reported dryness evaluations will be performed at baseline and weeks 1, 2, 6, 12, and 24 using a 4 point scale (0=None; 3=Severe).

  12. Mean change in scaling (tolerance) parameter [ Time Frame: Baseline, Week 1, Week 2, Week 6, Week 12, Week 24 ]
    Investigator-reported scaling evaluations will be performed at baseline and weeks 1, 2, 6, 12, and 24 using a 4 point scale (0=None; 3=Severe).

  13. Mean change in stinging/burning (tolerance) parameter [ Time Frame: Baseline, Week 1, Week 2, Week 6, Week 12, Week 24 ]
    Subject-reported stinging/burning evaluations will be performed at baseline and weeks 1, 2, 6, 12, and 24 using a 4 point scale (0=None; 3=Severe).



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Key Inclusion Criteria:

  1. Men and women age 21 to 45 years at the time of enrollment.
  2. Individuals with mild to moderate acne (score of 2-3 on FDA Investigator's Global Assessment Scale1) on the face.
  3. Individuals with at least 5 inflammatory lesions.
  4. Individuals with 10 - 100 non-inflammatory lesions.
  5. Fitzpatrick skin type I-VI
  6. Individuals willing to provide written informed consent including photo release, Health Insurance Portability and Accountability Act (HIPAA), and are able to read, speak,write, understand English.
  7. Willing to withhold all facial treatments during the course of the study
  8. Individuals of child bearing potential who use an acceptable method of contraception throughout the study.
  9. Subjects must be stable on any medication they are taking for at least 30 days.

Key Exclusion Criteria:

  1. Individuals diagnosed with allergies to topical acne products.
  2. Individuals having a condition and/or disease of the skin that the Investigator deems inappropriate for participation.
  3. Women who are nursing, pregnant, or planning to become pregnant during the study.
  4. Individuals who have pre-existing or dormant dermatologic conditions on the face which in the opinion of the Investigator could interfere with the outcome of the study.
  5. Individuals using or who have used any systemic medication considered to affect the course of acne, specifically, but not exclusively antibiotics or steroids within the last 30 days prior to entry into the study.
  6. Individuals who are currently participating in another facial usage study or have participated in a clinical trial within 4 weeks prior to inclusion into the study.
  7. Individuals with any planned surgeries and/or invasive medical procedures during the course of the study.
  8. Individuals who started hormone replacement therapies (HRT) or hormones for birth control less than 3 months prior to study entry or who plan on starting, stopping, or changing doses of HRT or hormones for birth control during the study.
  9. Individuals with facial sunburn or excessive tanned facial skin or that are not willing to avoid daily sun exposure on the face and the use of tanning beds or sunless tanning products for the duration of the study.
  10. Individuals that are currently taking or have taken within the last 30 days oral or topical prescription medications for acne.

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): NCT02755545


Locations
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United States, Texas
Stephens & Associates, Inc. Texas Research Center
Richardson, Texas, United States
Sponsors and Collaborators
Galderma Laboratories, L.P.
Investigators
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Study Chair: Karen Hernandez, BS Galderma Laboratories

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Responsible Party: Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier: NCT02755545     History of Changes
Other Study ID Numbers: GLI.04.SPR.US10354
First Posted: April 29, 2016    Key Record Dates
Last Update Posted: August 2, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Adapalene
Salicylates
Salicylic Acid
Benzoyl Peroxide
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Dermatologic Agents
Anti-Infective Agents
Antifungal Agents
Keratolytic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action