Safety and Efficacy Trial of ACZONE (Dapsone) Gel, 7.5% in 9 to 11 Year-Old Patients With Acne Vulgaris

A Phase 4 study testing dapsone gel in people with Acne Vulgaris, run by Almirall, S.A. at 20 sites in United States.

Completed

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

Trial summary

This study will evaluate the safety, tolerability, pharmacokinetics (PK) and efficacy of ACZONE Gel, 7.5% administered topically once-daily for 12 weeks in 9 to 11 year-olds with acne vulgaris. Read more about this study

Who is it for?: Ages 9 to 11 years
Conditions the study is for: Acne Vulgaris
What is being tested?: dapsone gel
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 20 sitesUnited States
Study dates: 31 Oct 2016to 9 Mar 2018
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 9 to 11 years
All sexes
No healthy volunteers
Child

Who may be able to join

-Has acne vulgaris on the face, including the nose, with 20 to 100 total lesions (noninflammatory and/or inflammatory).

Who cannot join

Has uncontrolled systemic disease(s)
Has severe cystic acne, acne conglobata, acne fulminans, or secondary acne (chloracne, drug-induced acne)
Has used topical dapsone within 1 month prior to the screening
Has used oral dapsone within 2 months prior to screening.

Trial locations and contacts

20 sites in 1 country.

City, postcode or hospital

20 sites in 1 country

United States20 sites

Arlington Research Center, Inc.
Arlington, Texas, 76011
DermResearch, LLC
Austin, Texas, 78759
Center for Clinical and Cosmetic Research
Aventura, Florida, 33180
Kirklin Clinic
Birmingham, Alabama, 35233
KGL Skin Study Center
Broomall, Pennsylvania, 19008
Hamzavi Dermatology
Fort Gratiot, Michigan, 48059
Center for Dermatology Clinical Research
Fremont, California, 94538
Department of Dermatology, UPCII
Hershey, Pennsylvania, 17033
University of Texas Medical School at Houston
Houston, Texas, 77030
Dermresearch, PLLC
Louisville, Kentucky, 40217
Baumann Cosmetic and Research Institute
Miami Beach, Florida, 33137
Skin Specialty Dermatology
New York, New York, 10155
Quest Dermatology Research
Northridge, California, 91324
Skin Specialists, PC
Omaha, Nebraska, 68144
Austin Institute for Clinical Research, Inc.
Pflugerville, Texas, 78660
Southern California Dermatology
Santa Ana, California, 92701
Redwood Family Dermatology
Santa Rosa, California, 95401
Premier Clinical Research
Spokane, Washington, 99202
Saint Louis University Dermatology
St Louis, Missouri, 63104
Health Sciences/Department of Dermatology
Winston-Salem, North Carolina, 27106

Other trials in United States

About this study

Official title: An Open-Label Phase 4 Safety and Efficacy Trial of ACZONE (Dapsone) Gel, 7.5% in 9 to 11 Year-Old Patients With Acne Vulgaris

This study will evaluate the safety, tolerability, pharmacokinetics (PK) and efficacy of ACZONE Gel, 7.5% administered topically once-daily for 12 weeks in 9 to 11 year-olds with acne vulgaris.

Conditions: Acne Vulgaris
Being tested: dapsone gel
Medical subject headings: Acne Vulgaris

What participants receive

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

dapsone gelDrug
Also called ACZONE
Dapsone (ACZONE) 7.5% gel topically once daily.

Study groups in NCT02959970
Study group	Role	What they receive
PK Cohort: ACZONE 7.5%	Experimental	Participants applied ACZONE 7.5 % gel topically, once-daily to the entire face, neck, upper chest, upper back and shoulders starting from Day 1 under maximal use conditions (2 grams per day) for Day 8 consecutive days, followed by a thin layer to their face and acne-affected areas on the upper chest, upper back, and shoulders for next 11 weeks. Receives: Drug: dapsone gel
Non-PK Cohort: ACZONE 7.5%	Experimental	Participants applied ACZONE 7.5% gel topically, once-daily in a thin layer to their face and acne-affected areas on upper chest, upper back, and shoulders for 12 weeks. Receives: Drug: dapsone gel

What is being measured

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

Number of Participants With Adverse Events (AE)
An AE was defined as "any untoward medical occurrence in a clinical trial participant (regardless of the administration of the study drug and its causal relationship to it). An AE could therefore, be any unfavorable and unintended medical occurrence during the participant's participation in the trial, including deterioration of a pre-existing medical condition, an abnormal clinically significant finding in a laboratory assessment, or an abnormal clinically significant finding in the physical examination or vital sign.
Measured: From Baseline (Day 1) until Week 12
Change From Baseline in Systolic and Diastolic Blood Pressure
Change from baseline in systolic and diastolic blood pressure was evaluated. Change from baseline was calculated by subtracting post-dose value from baseline value.
Measured: Baseline (Day 1), Week 12
Change From Baseline in Heart Rate
Change from baseline in heart rate was evaluated. Change from baseline was calculated by subtracting post-dose value from baseline value.
Measured: Baseline (Day 1), Week 12
Change From Baseline in Respiratory Rate
Change from baseline in respiratory rate was assessed. Change from baseline was calculated by subtracting post-dose value from baseline value.
Measured: Baseline (Day 1), Week 12
Change From Baseline in Body Temperature
Change from baseline in body temperature was assessed. Change from baseline was calculated by subtracting post-dose value from baseline value.
Measured: Baseline (Day 1), Week 12
Change From Baseline in Weight
Change from baseline in weight was assessed. Change from baseline was calculated by subtracting post-dose value from baseline value.
Measured: Baseline (Day 1), Week 12
Change From Baseline in Height
Change from baseline in height was assessed. Change from baseline was calculated by subtracting post-dose value from baseline value.
Measured: Baseline (Day 1), Week 12
Local Dermal Tolerability: Number of Participants With Dryness, Scaling and Erythema as Assessed by Investigator
Local dermal tolerability was evaluated by investigator in terms of presence and absence of dryness, scaling and erythema symptoms and its severity in the areas of body where medication was applied. These symptoms were assessed by using a 4 - point scale of 0 - 3, where 0 = none (no dryness, scaling and erythema) and 3 = severe (marked roughness, heavy scale production and intense redness). The higher score indicated severe symptoms.
Measured: Week 12
Local Dermal Tolerability: Number of Participants With Stinging/Burning Symptoms as Assessed by Participants
Local dermal tolerability was evaluated by participants in terms of presence and absence of prickling pain sensation immediately after (within 5 minutes of dosing) and its severity in the areas of body where medication was applied (face). Stinging/burning symptoms were graded on a 4-point scale of 0 - 3 where 0 = none (no stinging/burning), 1 = mild (slight warm, tingling/stinging sensation; not really bothersome), 2 = moderate (definite warm, tingling/stinging sensation that is somewhat bothersome), 3 = severe (hot, tingling/stinging sensation that has caused definite discomfort). The higher score indicated severe symptoms.
Measured: Week 12

Timeline

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

31 Oct 20169 Mar 2018

First posted9 Nov 2016 (estimated)
Study start31 Oct 2016
Primary completion9 Mar 2018
Study completion9 Mar 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Acne VulgarisStudies of the same condition, open and under way.
More trials run by Almirall, S.A.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02959970
Sponsor's protocol ID: 1679-401-006
Status last verified: Feb 2020
First submitted: 7 Nov 2016
Last updated: 3 Mar 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Acne Vulgaris trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label Phase 4 Safety and Efficacy Trial of ACZONE (Dapsone) Gel, 7.5% in 9 to 11 Year-Old Patients With Acne Vulgaris
ClinicalTrials.gov ID: NCT02959970
Acronym / sponsor ID: 1679-401-006
Conditions: Acne Vulgaris
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Almirall, S.A.Industry (pharma, biotech, devices)
Collaborators: Allergan
Study start: 31 Oct 2016 (actual)
Primary completion: 9 Mar 2018 (actual)
Study completion: 9 Mar 2018 (actual)
First posted: 9 Nov 2016 (estimated)
Results: Posted 13 Feb 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study will evaluate the safety, tolerability, pharmacokinetics (PK) and efficacy of ACZONE Gel, 7.5% administered topically once-daily for 12 weeks in 9 to 11 year-olds with acne vulgaris.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
PK Cohort: ACZONE 7.5%	Experimental	Drug: dapsone gelParticipants applied ACZONE 7.5 % gel topically, once-daily to the entire face, neck, upper chest, upper back and shoulders starting from Day 1 under maximal use conditions (2 grams per day) for Day 8 consecutive days, followed by a thin layer to their face and acne-affected areas on the upper chest, upper back, and shoulders for next 11 weeks.
Non-PK Cohort: ACZONE 7.5%	Experimental	Drug: dapsone gelParticipants applied ACZONE 7.5% gel topically, once-daily in a thin layer to their face and acne-affected areas on upper chest, upper back, and shoulders for 12 weeks.

Who may qualify

Ages: 9 to 11 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (1 listed)

-Has acne vulgaris on the face, including the nose, with 20 to 100 total lesions (noninflammatory and/or inflammatory).

Key exclusion criteria (4 listed)

Has uncontrolled systemic disease(s)
Has severe cystic acne, acne conglobata, acne fulminans, or secondary acne (chloracne, drug-induced acne)
Has used topical dapsone within 1 month prior to the screening
Has used oral dapsone within 2 months prior to screening.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
dapsone gelAlso: ACZONEDapsone (ACZONE) 7.5% gel topically once daily.	Drug	Non-PK Cohort: ACZONE 7.5%, PK Cohort: ACZONE 7.5%

Primary outcome

Number of Participants With Adverse Events (AE)
Time frame: From Baseline (Day 1) until Week 12
An AE was defined as "any untoward medical occurrence in a clinical trial participant (regardless of the administration of the study drug and its causal relationship to it). An AE could therefore, be any unfavorable and unintended medical occurrence during the participant's participation in the trial, including deterioration of a pre-existing medical condition, an abnormal clinically significant finding in a laboratory assessment, or an abnormal clinically significant finding in the physical examination or vital sign.
Change From Baseline in Systolic and Diastolic Blood Pressure
Time frame: Baseline (Day 1), Week 12
Change from baseline in systolic and diastolic blood pressure was evaluated. Change from baseline was calculated by subtracting post-dose value from baseline value.
Change From Baseline in Heart Rate
Time frame: Baseline (Day 1), Week 12
Change from baseline in heart rate was evaluated. Change from baseline was calculated by subtracting post-dose value from baseline value.
Change From Baseline in Respiratory Rate
Time frame: Baseline (Day 1), Week 12
Change from baseline in respiratory rate was assessed. Change from baseline was calculated by subtracting post-dose value from baseline value.
Change From Baseline in Body Temperature
Time frame: Baseline (Day 1), Week 12
Change from baseline in body temperature was assessed. Change from baseline was calculated by subtracting post-dose value from baseline value.
Change From Baseline in Weight
Time frame: Baseline (Day 1), Week 12
Change from baseline in weight was assessed. Change from baseline was calculated by subtracting post-dose value from baseline value.
Change From Baseline in Height
Time frame: Baseline (Day 1), Week 12
Change from baseline in height was assessed. Change from baseline was calculated by subtracting post-dose value from baseline value.
Local Dermal Tolerability: Number of Participants With Dryness, Scaling and Erythema as Assessed by Investigator
Time frame: Week 12
Local dermal tolerability was evaluated by investigator in terms of presence and absence of dryness, scaling and erythema symptoms and its severity in the areas of body where medication was applied. These symptoms were assessed by using a 4 - point scale of 0 - 3, where 0 = none (no dryness, scaling and erythema) and 3 = severe (marked roughness, heavy scale production and intense redness). The higher score indicated severe symptoms.
Local Dermal Tolerability: Number of Participants With Stinging/Burning Symptoms as Assessed by Participants
Time frame: Week 12
Local dermal tolerability was evaluated by participants in terms of presence and absence of prickling pain sensation immediately after (within 5 minutes of dosing) and its severity in the areas of body where medication was applied (face). Stinging/burning symptoms were graded on a 4-point scale of 0 - 3 where 0 = none (no stinging/burning), 1 = mild (slight warm, tingling/stinging sensation; not really bothersome), 2 = moderate (definite warm, tingling/stinging sensation that is somewhat bothersome), 3 = severe (hot, tingling/stinging sensation that has caused definite discomfort). The higher score indicated severe symptoms.

Results and safety

Results posted to the registry on 13 Feb 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PK Cohort: ACZONE 7.5%	17	15
Non-PK Cohort: ACZONE 7.5%	83	76

Primary outcome: Number of Participants With Adverse Events (AE)

Time frame: From Baseline (Day 1) until Week 12. Count of participants. Unit: Participants

Measure	PK Cohort: ACZONE 7.5% n = 17	Non-PK Cohort: ACZONE 7.5% n = 83
Value	5	16

Population analysed: Safety population included all participants who received at least one application of study drug.

Primary outcome: Change From Baseline in Systolic and Diastolic Blood Pressure

Time frame: Baseline (Day 1), Week 12. Mean (Standard Deviation). Unit: millimeter of mercury (mmHg)

Measure	PK Cohort: ACZONE 7.5% n = 17	Non-PK Cohort: ACZONE 7.5% n = 83
Systolic Blood Pressure	3.9 (8.2)	0.1 (10.1)
Diastolic Blood Pressure	2.3 (5.9)	0.4 (9.1)

Population analysed: Safety population included all participants who received at least one application of study drug.

Primary outcome: Change From Baseline in Heart Rate

Time frame: Baseline (Day 1), Week 12. Mean (Standard Deviation). Unit: beats per minute (beats/min)

Measure	PK Cohort: ACZONE 7.5% n = 17	Non-PK Cohort: ACZONE 7.5% n = 83
Value	-0.8 (14.0)	0.6 (9.5)

Population analysed: Safety population included all participants who received at least one application of study drug.

Primary outcome: Change From Baseline in Respiratory Rate

Time frame: Baseline (Day 1), Week 12. Mean (Standard Deviation). Unit: breaths per minute (breaths/min)

Measure	PK Cohort: ACZONE 7.5% n = 17	Non-PK Cohort: ACZONE 7.5% n = 83
Value	0.5 (2.4)	-0.1 (1.6)

Population analysed: Safety population included all participants who received at least one application of study drug.

Adverse events

Time frame: From baseline (Day 1) until Week 12. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PK Cohort	0 of 17 (0%)	5 of 17 (29.4%)	0 of 17
Non-PK Cohort	0 of 83 (0%)	16 of 83 (19.3%)	0 of 83

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Acne Vulgaris

Not yet recruitingPhase 3
Evaluation of the Efficacy and Safety of Fractional CO₂ Laser With and Without Intradermal Botulinum Toxin A in the Treatment of Inflammatory Facial Acne Vulgaris.
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RecruitingPhase 4
Safety, Tolerability, and Clinical Effectiveness of Adapalene/Clindamycin Phosphate Gel (Klenzit®-C) in Vietnamese Patients With Mild to Moderate Acne Vulgaris
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Cathy Truong study director

Allergan

20 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing dapsone gel in people with Acne Vulgaris, run by Almirall, S.A. at 20 sites 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 1 inclusion and 4 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 3 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites 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 13 Feb 2020). 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?

Number of Participants With Adverse Events (AE) (time frame: From Baseline (Day 1) until Week 12). The study lists 9 primary outcomes in all. 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 NCT02959970.

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 3 Mar 2020.