A Treatment for Severe Inflammatory Acne Subjects

NCT02899000 | Completed Phase 4 Results

• 1 other identifier: GLI.04.SPR.US10355
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

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.

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

• Change in Number of Inflammatory Lesions

  Change in Number of Inflammatory Lesions from baseline.

  Week 12

Secondary Outcomes (10)

• Number and Percent of Subjects With IGA Success

  Weeks 4, 8, and 12

• Percent Change From Baseline in Total Lesion Count

  Weeks 4, 8, and 12

• Change From Baseline in Total Lesion Count

  Weeks 4, 8, and 12

• Percent Change From Baseline in Inflammatory Lesion Count

  Weeks 4, 8, and 12

• Change From Baseline in Inflammatory Lesion Count

  Weeks 4, 8, and 12

Study Arms (1)

Acne treatment

EXPERIMENTAL

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; Drug: Oral doxycycline hyclate

Interventions

Adapalene 0.3% / benzoyl peroxide 2.5% emulsion gel DRUG

Topical acne therapy

Also known as: Epiduo Forte

Acne treatment

Oral doxycycline hyclate DRUG

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

Acne treatment

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (1)

Galderma Laboratories, LP

Fort Worth, Texas, 76177, United States

Location

Related Publications (1)

• 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.

  PMID: 29537444 DERIVED

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Adapalene; Benzoyl Peroxide; Adapalene, Benzoyl Peroxide Drug Combination; Doxycycline

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Drug Combinations; Pharmaceutical Preparations; Tetracyclines; Naphthacenes

Results Point of Contact

• Title: Dr. Jean Philippe York, Medical Affairs Manager
• Organization: Galderma Laboratories, LP

jp.york@galderma.com

1-817-961-5468

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2016
• First Posted: September 13, 2016
• Study Start: July 29, 2016
• Primary Completion: March 28, 2017
• Study Completion: June 27, 2017
• Last Updated: December 9, 2022
• Results First Posted: December 9, 2022

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)