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Acne VulgarisPhase 4NCT02899000

A Treatment for Severe Inflammatory Acne Subjects

A Phase 4 study testing Adapalene 0.3% / benzoyl peroxide 2.5% emulsion gel and Oral doxycycline hyclate in people with Acne Vulgaris, run by Galderma R&D at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Acne Vulgaris
What is being tested?
Adapalene 0.3% / benzoyl peroxide 2.5% emulsion gel and Oral doxycycline hyclate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
186 participants
Where
1 siteUnited States
Study dates
29 Jul 2016to 27 Jun 2017
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.)

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Galderma Laboratories, LP

    Fort Worth, Texas, 76177

Other trials in United States

About this study

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

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.

Read the 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.
Conditions
Acne Vulgaris
Being tested
Adapalene 0.3% / benzoyl peroxide 2.5% emulsion gel, Oral doxycycline hyclate
Medical subject headings
Acne Vulgaris

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adapalene 0.3% / benzoyl peroxide 2.5% emulsion gelDrug

    Also called Epiduo Forte

    Topical acne therapy

  • Oral doxycycline hyclateDrug

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

Study groups in NCT02899000
Study groupRoleWhat they receive
Acne treatmentExperimentalTopical 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)
Receives: Drug: Adapalene 0.3% / benzoyl peroxide 2.5% emulsion gel; Drug: Oral doxycycline hyclate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Number of Inflammatory Lesions

    Change in Number of Inflammatory Lesions from baseline.

    Measured: Week 12

Secondary outcomes (10)

  1. 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)

    Measured: Weeks 4, 8, and 12

  2. Percent Change From Baseline in Total Lesion Count

    Percent Change From Baseline in Total Lesion Count.

    Measured: Weeks 4, 8, and 12

  3. Change From Baseline in Total Lesion Count

    Change From Baseline in Total Lesion Count.

    Measured: Weeks 4, 8, and 12

  4. Percent Change From Baseline in Inflammatory Lesion Count

    Percent Change From Baseline in Inflammatory Lesion Count.

    Measured: Weeks 4, 8, and 12

  5. Change From Baseline in Inflammatory Lesion Count

    Change From Baseline in Inflammatory Lesion Count.

    Measured: Weeks 4, 8, and 12

  6. Percent Change From Baseline in Non-Inflammatory Lesion Count

    Percent Change From Baseline in Non-Inflammatory Lesion Count.

    Measured: Weeks 4, 8, and 12

  7. Change From Baseline in Non-Inflammatory Lesion Count

    Change From Baseline in Non-Inflammatory Lesion Count.

    Measured: Weeks 4, 8, and 12

  8. 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."

    Measured: Weeks 0, 4, 8, and 12

  9. 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).

    Measured: Week 12

  10. Number and Percent of Adverse Events

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

    Measured: Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2016 (estimated)
  2. Study start29 Jul 2016
  3. Primary completion28 Mar 2017
  4. Study completion27 Jun 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
186 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02899000
Sponsor's protocol ID
GLI.04.SPR.US10355
Status last verified
Dec 2016
First submitted
8 Sep 2016
Last updated
9 Dec 2022
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 29537444

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Adapalene 0.3% / benzoyl peroxide 2.5% emulsion gel and Oral doxycycline hyclate in people with Acne Vulgaris, run by Galderma R&D at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Number of Inflammatory Lesions (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02899000, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2022.

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