A Study to Assess the Safety and Effectiveness of ELAPR002f Injectable Gel in Adult Participants With Atrophic Acne Scars
ConditionAcne Scars
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age22+
SponsorAbbVie
About this trial
Atrophic acne scars are flat, indented or with an inverted center scars that develop at the endpoint of the normal healing process for acne. Acne scarring that remains after acne resolves has a significant impact on health related quality of life, including reduced self-esteem and embarrassment/self consciousness. ELAPR002f provides an immediate space-occupying effect for filling in the scar tissue. The purpose of this study is to assess how safe and effective ELAPR002f injectable gel is on adult participants with atrophic acne scars.
ELAPR002f injectable gel is an investigational device being developed for the treatment of facial atrophic acne scars. There are 2 cohorts in this study. In Cohort 1, all participants will receive ELAPR002f injectable gel. In Cohort 2, participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 4 chance that participants will be assigned to the saline active control group. Around 395 adult participants with moderate to severe atrophic acne scarring on both cheeks will be screened in the study in approximately 25 sites in the United States.
Participants will receive 3 treatments over 2 months of intradermal injections of either ELAPR002f injectable gel or saline active control and will be followed for up to an additional 12 months.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants in general good health, and seeking improvement of atrophic acne scars.
Moderate to severe atrophic acne scarring (Grade 4 or 5 on the Allergan Acne Scar Improvement Scale [ASIS]) on each cheek based on evaluating investigator (EI) live assessment (both cheeks must qualify but do not need to have the same score) at the first Screening Visit.
At least 5 rolling or boxcar-type acne scars in total within the predefined 4 cm × 4 cm assessment field of either cheek in areas of otherwise normal healthy skin, as assessed by the treating investigator (TI).
Disqualifiers
The participant has clinically significant acne on the face.
Current cutaneous or mucosal inflammatory or infectious processes other than acne (eg, herpes), rosacea, abscess, an unhealed wound, or a cancerous or precancerous lesion, on the face.
The participant presents with predominantly ice pick scars.
History of keloid scar formation, hypertrophic scarring, and/or post inflammatory hyperpigmentation or hypopigmentation.
Trial design
Design model
Parallel
Treatments tested in this trial
ELAPR002f Injectable Gel
DeviceIntradermal Injections
Saline Control
DeviceIntradermal Injections
Treatment groups
395 Participants
are divided into 3 treatment groupsGroup A: Cohort 1: Open-Label ELAPR002f Injectable GelExperimental treatment 1 intervention
Group B: Cohort 2: ELAPR002f Injectable GelExperimental treatment 1 intervention
Group C: Cohort 2: Saline ControlExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Percentage of Participants who Achieve a 20% Reduction in Acne Scar Area
The acne scar area is calculated from 3D camera imaging software. Area is defined as the sum of the individual scar area of the 5 most prominent scars identified by the treating investigator (TI).
Time frame
Baseline to Day 1812
Number of Participants with Adverse Events
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Time frame
Up to Day 4203
Number of Participants with Presence of Binding Antibodies
Presence of binding antibodies followed by characterization through isotyping and evaluation of cross-reactivity to endogenous tissues.
Time frame
Up to Day 4204
Number of Participants with Injection Site Responses (ISRs) and Systemic Responses
Incidence of ISRs/systemic responses as recorded by e-diary. ISRs are defined as redness, pain after injection, tenderness to touch, firmness, swelling, lumps/bumps, bruising, itching and discoloration (not redness or bruising).
Time frame
Up to Day 420Secondary outcomes
1
Change from Baseline on the Overall Score of ACNE-Q Acne Scars Questionnaire
The ACNE-Q Acne Scars questionnaire includes 10 questions that ask how much the participant is bothered by their acne scars on a 4-point scale ranging from 1=Not at all to 4=Very Much.
Time frame
Up to Day 4202
Change from Baseline on the Overall Score of ACNE-Q - Appearance-Related Distress
ACNE-Q - Appearance-Related Distress questionnaire includes 8 questions that ask about how the participants describe themselves on a 4-point scale ranging from 1=Never to 4=Always.
Time frame
Up to Day 4203
Change from Baseline on the Overall Score of FACE-Q Satisfaction with Skin Total Score
FACE-Q Satisfaction With Skin questionnaire includes 12 questions that ask how much the participants are satisfied or dissatisfied with their facial skin on a 4-point scale ranging from 1=Very Dissatisfied to 4=Very Satisfied.
Time frame
Up to Day 4204
Percentage of Participants Achieving "Responder" Status on Either Cheek Based on the Allergan Acne Scar Improvement Scale (ASIS), as assessed by the Evaluating Investigator
A "responder" is a participant who achieves 1-grade improvement on either cheek based on the ASIS, as assessed by the EI. The ASIS is a 5-grade scale used to assess acne scar improvement ranging from 1=Almost None to 5=Severe. Each side of the face is scored separately.
Time frame
Up to Day 420 Source ClinicalTrials.gov