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A Treatment for Severe Inflammatory Acne Subjects

Primary Purpose

Acne Vulgaris

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Adapalene 0.3% / benzoyl peroxide 2.5% emulsion gel

Oral doxycycline hyclate

About this trial

This is an interventional treatment trial for Acne Vulgaris

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

Male or female subjects, 12 years of age or older at Screening visit.
Subjects with a clinical diagnosis of severe inflammatory acne (IGA score of 4).
Subjects with 4 or fewer nodules or cysts > 1 cm in diameter on the face.
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:

Subjects with nodulocystic or conglobate acne, acne fulminans, or secondary acne (chloracne, drug-induced acne, etc.).
Subjects with 5 or more acne nodules or cysts > 1 cm in diameter on the face at Screening and Baseline visits.
Female subjects who are pregnant, nursing, or planning a pregnancy during the study.
Subjects who have used any systemic therapy directed at improving acne, including antibiotics, within 30 days prior to Baseline visit.
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).
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.
Sponsor and study site staff, relatives of staff members, or other individuals who would have access to the clinical study protocol.

Sites / Locations

Galderma Laboratories, LP

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Acne treatment

Arm Description

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)

Outcomes

Primary Outcome Measures

Change in Number of Inflammatory Lesions

Change in Number of Inflammatory Lesions from baseline.

Secondary Outcome Measures

Number and Percent of Subjects With IGA Success

IGA Success is defined as an IGA rating of Clear (Grade 0) or Almost Clear (Grade 1)

Percent Change From Baseline in Total Lesion Count

Percent Change From Baseline in Total Lesion Count.

Change From Baseline in Total Lesion Count

Change From Baseline in Total Lesion Count.

Percent Change From Baseline in Inflammatory Lesion Count

Percent Change From Baseline in Inflammatory Lesion Count.

Change From Baseline in Inflammatory Lesion Count

Change From Baseline in Inflammatory Lesion Count.

Percent Change From Baseline in Non-Inflammatory Lesion Count

Percent Change From Baseline in Non-Inflammatory Lesion Count.

Change From Baseline in Non-Inflammatory Lesion Count

Change From Baseline in Non-Inflammatory Lesion Count.

Investigator's Evaluation: Number of Subjects Not Considered to be Oral Isotretinoin Candidates

At each visit, subjects were evaluated by the investigator to determine whether (in the opinion of the investigator) they would consider them as candidates for oral isotretinoin therapy. The outcome measure reports the number and % of subjects who, in the opinion of the investigator, were not considered to be "a candidate for oral isotretinoin therapy."

Subject Assessment of Acne Improvement

Subject Assessment of Acne Improvement on a 6 point scale (0 = Complete Improvement, 1 = Marked Improvement, 2 = Moderate Improvement, 3 = Minimal Improvement, 4 = No Change, 5 = Worse).

Number and Percent of Adverse Events

Number and percent of subjects with any Treatment-Related Adverse Event

Full Information

NCT ID

NCT02899000

First Posted

September 8, 2016

Last Updated

November 14, 2022

Sponsor

Galderma R&D

1. Study Identification

Unique Protocol Identification Number

NCT02899000

Brief Title

A Treatment for Severe Inflammatory Acne Subjects

Official Title

Efficacy and Safety of Adapalene 0.3%/Benzoyl Peroxide 2.5% Gel Plus Doxycycline in Severe Inflammatory Acne (Non-Nodulocystic) Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

December 2016

Overall Recruitment Status

Completed

Study Start Date

July 29, 2016 (Actual)

Primary Completion Date

March 28, 2017 (Actual)

Study Completion Date

June 27, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Galderma R&D

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

This Phase 4, 12-week, single-arm, open-label, multi-center investigational efficacy and safety study was conducted in subjects with severe inflammatory acne. Subjects who met the inclusion criteria and none of the exclusion criteria at the Screening visit returned to the clinic for baseline measures (Week 0) and to start treatment, which continued for up to 12 weeks. Treatment consisted of 2 investigational study drugs: A/BPO 0.3%/2.5% gel applied to dry skin as directed by study staff once daily for 12 weeks, at night after washing. Doxycycline hyclate 200 mg: each subject was to take 2 50-mg tablets of doxycycline hyclate in the morning and 2 at night, for a total of 4 tablets (a total of 200 mg) daily for 12 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acne Vulgaris

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

186 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Acne treatment

Arm Type

Experimental

Arm Description

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)

Intervention Type

Drug

Intervention Name(s)

Adapalene 0.3% / benzoyl peroxide 2.5% emulsion gel

Other Intervention Name(s)

Epiduo Forte

Intervention Description

Topical acne therapy

Intervention Type

Drug

Intervention Name(s)

Oral doxycycline hyclate

Intervention Description

Tetracycline-class oral antibacterial 200 mg daily (2 tablets [50 mg], twice daily)

Primary Outcome Measure Information:

Title

Change in Number of Inflammatory Lesions

Description

Change in Number of Inflammatory Lesions from baseline.

Time Frame

Week 12

Secondary Outcome Measure Information:

Title

Number and Percent of Subjects With IGA Success

Description

IGA Success is defined as an IGA rating of Clear (Grade 0) or Almost Clear (Grade 1)

Time Frame

Weeks 4, 8, and 12

Title

Percent Change From Baseline in Total Lesion Count

Description

Percent Change From Baseline in Total Lesion Count.

Time Frame

Weeks 4, 8, and 12

Title

Change From Baseline in Total Lesion Count

Description

Change From Baseline in Total Lesion Count.

Time Frame

Weeks 4, 8, and 12

Title

Percent Change From Baseline in Inflammatory Lesion Count

Description

Percent Change From Baseline in Inflammatory Lesion Count.

Time Frame

Weeks 4, 8, and 12

Title

Change From Baseline in Inflammatory Lesion Count

Description

Change From Baseline in Inflammatory Lesion Count.

Time Frame

Weeks 4, 8, and 12

Title

Percent Change From Baseline in Non-Inflammatory Lesion Count

Description

Percent Change From Baseline in Non-Inflammatory Lesion Count.

Time Frame

Weeks 4, 8, and 12

Title

Change From Baseline in Non-Inflammatory Lesion Count

Description

Change From Baseline in Non-Inflammatory Lesion Count.

Time Frame

Weeks 4, 8, and 12

Title

Investigator's Evaluation: Number of Subjects Not Considered to be Oral Isotretinoin Candidates

Description

Time Frame

Weeks 0, 4, 8, and 12

Title

Subject Assessment of Acne Improvement

Description

Subject Assessment of Acne Improvement on a 6 point scale (0 = Complete Improvement, 1 = Marked Improvement, 2 = Moderate Improvement, 3 = Minimal Improvement, 4 = No Change, 5 = Worse).

Time Frame

Week 12

Title

Number and Percent of Adverse Events

Description

Number and percent of subjects with any Treatment-Related Adverse Event

Time Frame

Week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key Inclusion Criteria: Male or female subjects, 12 years of age or older at Screening visit. Subjects with a clinical diagnosis of severe inflammatory acne (IGA score of 4). Subjects with 4 or fewer nodules or cysts > 1 cm in diameter on the face. 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: Subjects with nodulocystic or conglobate acne, acne fulminans, or secondary acne (chloracne, drug-induced acne, etc.). Subjects with 5 or more acne nodules or cysts > 1 cm in diameter on the face at Screening and Baseline visits. Female subjects who are pregnant, nursing, or planning a pregnancy during the study. Subjects who have used any systemic therapy directed at improving acne, including antibiotics, within 30 days prior to Baseline visit. 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). 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. Sponsor and study site staff, relatives of staff members, or other individuals who would have access to the clinical study protocol.

Facility Information:

Facility Name

Galderma Laboratories, LP

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76177

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

29537444

Citation

Del Rosso JQ, Stein Gold L, Johnson SM, Rueda MJ, Baldwin H, Lain EL, Landis M, Rendon M, Tanghetti E, Weiss J. Efficacy and Safety of Adapalene 0.3%/Benzoyl Peroxide 2.5% Gel Plus Oral Doxycycline in Subjects With Severe Inflammatory Acne Who Are Candidates for Oral Isotretinoin. J Drugs Dermatol. 2018 Mar 1;17(3):264-273.

Results Reference

derived

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A Treatment for Severe Inflammatory Acne Subjects

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