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A Treatment for Severe Inflammatory Acne Subjects

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ClinicalTrials.gov Identifier: NCT02899000
Recruitment Status : Completed
First Posted : September 13, 2016
Last Update Posted : November 1, 2017
Sponsor:
Information provided by (Responsible Party):
Galderma Laboratories, L.P.

Brief Summary:
Demonstrate that a daily treatment regimen of adapalene 0.3%/benzoyl peroxide 2.5% gel + oral Doxycycline 200 mg is effective and safe in severe inflammatory acne with 3 or fewer nodules or cysts (non-nodulocystic) during a 12-week treatment period.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: Adapalene 0.3% / benzoyl peroxide 2.5% emulsion gel Drug: Oral doxycycline hyclate Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 186 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Adapalene 0.3%/Benzoyl Peroxide 2.5% Gel Plus Doxycycline in Severe Inflammatory Acne (Non-Nodulocystic) Subjects
Actual Study Start Date : July 29, 2016
Actual Primary Completion Date : March 28, 2017
Actual Study Completion Date : June 27, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Experimental: Acne treatment

Topical adapalene 0.3% / benzoyl peroxide 2.5% emulsion gel (one application daily for 12 weeks)

Oral doxycycline hyclate, 200 mg per day (two 50-mg tablets twice daily for 12 weeks)

Drug: Adapalene 0.3% / benzoyl peroxide 2.5% emulsion gel
Topical acne therapy
Other Name: Epiduo Forte

Drug: Oral doxycycline hyclate
Tetracycline-class oral antibacterial 200 mg daily (2 tablets [50 mg], twice daily)




Primary Outcome Measures :
  1. Reduction in Number of Inflammatory Lesions [ Time Frame: Week 12 ]

Secondary Outcome Measures :
  1. IGA Success [ Time Frame: Weeks 4, 8, and 12 ]
    IGA Success is defined as an IGA rating of Clear (Grade 0) or Almost Clear (Grade 1)

  2. Percent Change From Baseline in Total Lesion Count [ Time Frame: Weeks 4, 8, and 12 ]
  3. Change From Baseline in Total Lesion Count [ Time Frame: Weeks 4, 8, and 12 ]
  4. Percent Change From Baseline in Inflammatory Lesion Count [ Time Frame: Weeks 4, 8, and 12 ]
  5. Change From Baseline in Inflammatory Lesion Count [ Time Frame: Weeks 4, 8, and 12 ]
  6. Percent Change From Baseline in Non-Inflammatory Lesion Count [ Time Frame: Weeks 4, 8, and 12 ]
  7. Change From Baseline in Non-Inflammatory Lesion Count [ Time Frame: Weeks 4, 8, and 12 ]
  8. Investigator's Acne Treatment Evaluation [ Time Frame: Weeks 0, 4, 8, and 12 ]
    Investigator's assessment of treatment suitability

  9. Subject Assessment of Acne Improvement [ Time Frame: Week 12 ]
  10. Incidence of Adverse Events [ Time Frame: Week 0, 4, 8, and 12 ]


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

Key Inclusion Criteria:

  1. Male or female subjects, 12 years of age or older at Screening visit.
  2. Subjects with a clinical diagnosis of severe inflammatory acne (IGA score of 4).
  3. Subjects with 4 or fewer nodules or cysts > 1 cm in diameter on the face.
  4. Subjects 18 years of age or older must read and sign the Informed Consent Form, which includes Photography Consent and HIPAA authorization, prior to any participation in the study. Consent will be obtained prior to any study-related procedures. Subjects under the age of 18 years must sign an Assent to Participate Form to participate in the study and must have one parent or guardian read and sign the Informed Consent Form prior to any study-related procedure. (The parent or guardian is not required to attend the following visits unless requested.)

Key Exclusion Criteria:

  1. Subjects with nodulocystic or conglobate acne, acne fulminans, or secondary acne (chloracne, drug-induced acne, etc.).
  2. Subjects with 5 or more acne nodules or cysts > 1 cm in diameter on the face at Screening and Baseline visits.
  3. Female subjects who are pregnant, nursing, or planning a pregnancy during the study.
  4. Subjects who have used any systemic therapy directed at improving acne, including antibiotics, within 30 days prior to Baseline visit.
  5. Subjects who are at risk in terms of precautions, warnings, and contraindications for the investigational study drugs (see Appendix 14.1 for package inserts for adapalene 0.3%/benzoyl peroxide 2.5% gel and doxycycline hyclate Tablets).
  6. Subjects with any other condition or circumstance which, in the Investigator's opinion, may put the subject at risk (e.g., a history of significant renal disease with impairment of renal function), confound the study results, or interfere with the subject's participation in the study.
  7. Sponsor and study site staff, relatives of staff members, or other individuals who would have access to the clinical study protocol.

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): NCT02899000


Locations
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United States, Texas
Galderma Laboratories, LP
Fort Worth, Texas, United States, 76177
Sponsors and Collaborators
Galderma Laboratories, L.P.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier: NCT02899000     History of Changes
Other Study ID Numbers: GLI.04.SPR.US10355
First Posted: September 13, 2016    Key Record Dates
Last Update Posted: November 1, 2017
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Acne Vulgaris
Benzoyl Peroxide
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Doxycycline
Adapalene
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Dermatologic Agents
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