Acne Vulgaris Superficial Mixed Comedonal and InflammatoryPhase 1/2NCT03076320
Pirfenidone Plus M-DDO Gel in Moderate and Severe Acne
A Phase 1/2 study testing PDF+M-DDO and A+PBO in people with Acne Vulgaris Superficial Mixed Comedonal and Inflammatory, run by University of Guadalajara at 1 site in Mexico.
Trial summary
Acne vulgaris is a complex skin disorder involving multiple abnormalities of the pilosebaceous unit. Acne is the most common skin disease during puberty and worsens throughout adolescence. Read more about this study
- Who is it for?
- Ages 12 to 25 years
- Conditions the study is for
- Acne Vulgaris Superficial Mixed Comedonal and Inflammatory
- What is being tested?
- PDF+M-DDO and A+PBO
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteMexico
- Study dates
- 27 Mar 2017to 31 Mar 2019
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Subjects of both genders male or female of any race, 12 to 25 years or age.
- Subjects with a clinical diagnosis of acne vulgaris with facial and back involvement.
- Subjects with a minimum of 20 but not more tan 150 inflammatory lesions on the face (including the nose)
- Subjects with a minimum of 30 but no more 200 non-inflammatory lesions on the face (including the nose)
- Subjects with minimum of 20 but no more than 250 inflammatory lesions on the superior back area.
- Investigator's Global Assessment (IGA) score of 3 or 4, corresponding to moderate and severe acne. Subjects with no more than two active nodules at baseline.
Show all 11Show fewer
- Subjects that agree to fill a clinical history, access to physical exploration and biochemical analysis samples, biopsy of the back and photo-documentation of affected areas on the face and back.
- Consent to participate, verified by signing an approved written Informed Consent Form, or for subjects under age 18, an assent form in conjunction with a signed Informed Consent Form from a parent/guardian.
- Patients willing to sign a compliance letter to apply treatment as indicated by the principal investigator.
- Willingness and capacity of protocol compliance (for subjects under 18 years of age, parent/guardian must be wiling and able to comply with study requirements).
- Subjects willing to share personal information and data as verified by signing a written authorization, as applicable
Who cannot join
- Acne conglobata, acne fulminans, secondary acne.
- Subjects with another chronic inflammatory disease of the skin.
- Subjects with severe acne requiring isotretinoin therapy or other dermatological conditions, which might, in the opinion of the Investigator, interfere with the study evaluation or pose a risk to patient safety during the study.
- Pregnancy, nursing or planning a pregnancy.
- Men with facial hair that would interfere with the assessments.
- Subjects with background history of keloid scarring.
Show all 10Show fewer
- Known sensitivities to the study preparations.
- Participation in another investigational drug or device research study within 30 day of enrollment.
- Specified washout period to baselines for systemic or topical medications.
- Subjects refusing to the biopsy of the back and photographic procedures.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara, Jalisco, 44280
About this study
Official title: Molecular and Clinical Study of the Effect of Zaxcell Versus Effezel in the Inflammatory and Scarring Process of Moderate and Severe Acne
Acne vulgaris is a complex skin disorder involving multiple abnormalities of the pilosebaceous unit. Acne is the most common skin disease during puberty and worsens throughout adolescence. However, epidemiological studies suggest that acne can arise at any age, most frequently affecting individuals between puberty and 30 years of age, with 79%-95% of subjects aged between 16 years and 18 years and 80% of subjects between puberty and 30 years of age. Acne is considered the main reason for consultation with the dermatologist in institutional and private clinical practice.
Clinical features include seborrhoea, non-inflammatory lesions, inflammatory lesions and various degrees of scarring. There are many classifications of acne and scarring severity. Moderate to severe acne is about 15-20%.
Read more
Facial acne scarring affects both sexes equally and occurs to some degree in up to 95% of cases. There is a significant correlation between the initial acne grade and the overall severity of scarring at all sites and in both sexes. This would suggest that treatment aimed at reducing the severity of acne might reduce the incidence of scarring. Both superficial inflammatory acne lesions as well as deep nodular lesions seem capable of producing scars.
Conventional therapies recommended for the treatment of acne vulgaris include retinoids, benzoyl peroxide (BPO), antibiotics, and hormonal therapy. Combination therapy using agents with complementary mechanisms provides the opportunity to target multiple pathogenetic causes of acne vulgaris.
The combination in gel with 0.1% adapalene and 2.5% BPO is a once-daily treatment of acne vulgaris. In several double- blind, randomized controlled trials (RCTs), the Adapalene-BPO (A-BPO) combination therapy applied once daily for 12 weeks significantly reduced the number of both inflammatory and non-inflammatory lesions in subjects with moderate acne vulgaris. In Mexico there is an available commercial product of this combination (Effezel®; Galderma). The limitation of this topical therapy is the low tolerability by patients as they can experiment several levels of irritation, erythema, dryness, desquamation, burning, and itching), and patients are advised to expect these side effects, which contribute to discontinue therapy if it becomes severe.
On the other hand, 5-methyl-1-phenyl-2-(1h)-pyridone or pirfenidone (PFD) is a wide-spectrum antifibrotic drug that modulates diverse cytokines action, involving TGF-β, TNF-α, epidermal growth factor, platelet-derived growth factor, VEGF, IGF-1, fibroblast growth factor, interferon-γ, interleukin (IL)-1, IL-6, and IL-8 and it has shown promising effects in vitro and in vivo settings. Also, PFD has proven effective in the prevention and regression of pulmonary fibrosis, peritoneal sclerosis, hepatic cirrhosis, uterine fibromyoma, left ventricular fibrosis, renal interstitial fibrosis, and breast capsular contracture in experimental models. A recently open phase II clinical trial evaluated the therapeutic use of PFD gel in localized scleroderma. Results showed it acts on both the inflammatory and the fibrotic phases.
The other component of Zaxcell is modified-diallyl disulfide oxide (M-DDO) an antimicrobial and antiseptic agent, which has been proved in patients with chronic diabetic ulcer as a potent germicide and has show to increase the beneficial effect of PFD preventing infections, accelerating and improving ulcer resolution. (Observations not published).
According to this, the investigators believe that Zaxcell (PFD + M-DDO) could play an important role in the modulation of inflammatory and scarring process in acne. The investigators hypothesis is that PFD in patients with moderate to severe acne modulates amplification of the inflammatory response, regulating the inflammasome activation, macrophage polarization and its activity in regulating the wound healing process of the skin in an early fashion.
Zaxcell is an innovative gel with a synergetic mode of action that could modulate the inflammatory response. Furthermore, has antiseptic properties and regulates the process of wound healing, fibrogenic and scarring process. In vitro and in vivo studies provide an initial body of evidence on the safety and clinical benefits of PFD, the main component of Zaxcell as a promising candidate for the treatment of moderate to severe acne.
Read the detailed description
Participants will be randomized using a random number table to distribute in the control (Effezel) and the experimental group (Pirfenidone+M-DDO). Before screening, participants will undergo an informed consent process and they will sign an institutional review board-approved informed consent form. The study will be conducted in accordance with Good Clinical Practices and the principles that have their origins in the Declaration of Helsinki (revised Seoul, Korea, 2008). Potential subjects with acne scars will be selected from the investigators practices and solicited from advertisements. To be included, subjects must have met the inclusion criteria. Demographics data and medical history will be registered on a monthly basis. Before treatment, all subjects with inflammation and scars will be evaluated in the face and back area using the Investigator´s Global Assessment scale (IGA scale) and all the lesions will be counted. The face and back area affected will be mapped and photographed. Participants in the experimental group will receive topical Zaxcell (Pirfenidone 10% +M-DDO gel) two times a day on the face and superior back and patients in control group will receive Effezel (Adapalene 0.1%+Benzoyl peroxide 2.5%) once a day. Both groups will apply the topical treatment in acne on the face and superior back area for six months previous cleansing of the area with neutral soap. Two biopsies of skin will be taken at the beginning, at month one and month 3 from the back area where the treatment will be applied. After this time, only clinical evaluations and photographs will be performed. Participants will be evaluated at every month until 6 months after their last application.
- Being tested
- PDF+M-DDO, A+PBO
- Keywords
- Modified diallyl disulfide oxide (M-DDO), Pirfenidone (PFD), Adapalene + Benzoyl peroxide (A-BPO)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PDF+M-DDOCombination product
Also called Zaxcell, 5-methyl-phenyl-2(1h)- pyridone with M-DDO
Participants with moderate and severe acne will be treated two times a day on the face and superior back with a smooth layer (standard finger tip unit 0.5 g for an area of 100 to 120 square centimeters) of Zaxcell (Pirfenidone with M-DDO) in form of a gel. Patients have to wait 20 min without cover those sites.
A+PBOCombination product
Also called Effezel, Adapalene with benzoyl peroxide
Participants with moderate and severe acne will be treated once a day (at night) on the face and superior back with a smooth layer (standard finger tip unit 0.5 g for an area of 100 to 120 square centimeters) of Effezel (Adapalene with benzoyl peroxide) in form of a gel. Patients have to wait 20 min without cover those sites
| Study group | Role | What they receive |
|---|---|---|
| PFD+M-DDO | Experimental | Pirfenidone with M-DDO Active ingredients: Pirfenidone 10% with modified oxide diallyl disulfide (M-DDO) 0.016% Dosage form: gel. Dosage: standard finger tip unit (0.5g for an area of 100 to 120 square centimeters).
Frequency an duration: topically applied every 12 hours for 6 months. Receives: Combination Product: PDF+M-DDO |
| A+PBO | Active comparator | Adapalene with benzoyl peroxide Active ingredients: 0.1% Adapalene with 2.5% benzoyl peroxide. Dosage form: gel. Dosage: standard finger tip unit (0.5g for an area of 100 to 120 square centimeters).
Frequency and duration: topically applied every 12 hours for 6 month Receives: Combination Product: A+PBO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing change of lesions with IGA scale (Investigators' Global Assessment)
Number or lesions
Measured: 1, 2, 3, 4, 5 and 6 months
Secondary outcomes (3)
Histopathological modification on the inflammatory lesions and improvement in the scarring process
Biopsy from the upper back area
Measured: 1 and 3 months
2. Expression levels of key molecules involved in acne inflammation and scar remodeling
Biopsy from the upper back area
Measured: 1 and 3 months
Photonumeric scale
Photographs of the treated area analyzed by three-dimensional reconstruction software
Measured: 1, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2017
- Study start27 Mar 2017
- Primary completion31 Jan 2019
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Acne Vulgaris Superficial Mixed Comedonal and InflammatoryStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Guadalajara
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Civil de Guadalajara, Cell Pharma
- Responsible party
- Principal investigator, Juan Armendáriz-Borunda, PhD, FAASLD, University of Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03076320
- Sponsor's protocol ID
- IBMMTG 15-02
- Other IDs
- 008/16, 267/15
- Status last verified
- Jul 2023
- First submitted
- 6 Mar 2017
- Last updated
- 6 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gollnick HP, Finlay AY, Shear N; Global Alliance to Improve Outcomes in Acne. Can we define acne as a chronic disease? If so, how and when? Am J Clin Dermatol. 2008;9(5):279-84. doi: 10.2165/00128071-200809050-00001.
PubMed 18717602Kang S, Cho S, Chung JH, Hammerberg C, Fisher GJ, Voorhees JJ. Inflammation and extracellular matrix degradation mediated by activated transcription factors nuclear factor-kappaB and activator protein-1 in inflammatory acne lesions in vivo. Am J Pathol. 2005 Jun;166(6):1691-9. doi: 10.1016/s0002-9440(10)62479-0.
PubMed 15920154Macias-Barragan J, Sandoval-Rodriguez A, Navarro-Partida J, Armendariz-Borunda J. The multifaceted role of pirfenidone and its novel targets. Fibrogenesis Tissue Repair. 2010 Sep 1;3:16. doi: 10.1186/1755-1536-3-16.
PubMed 20809935Zhou R, Jiang X. Effects of adapalene-benzoyl peroxide combination gel in treatment or maintenance therapy of moderate or severe acne vulgaris: a meta-analysis. Ann Dermatol. 2014 Feb;26(1):43-52. doi: 10.5021/ad.2014.26.1.43. Epub 2014 Feb 17.
PubMed 24648685Rodriguez-Castellanos M, Tlacuilo-Parra A, Sanchez-Enriquez S, Velez-Gomez E, Guevara-Gutierrez E. Pirfenidone gel in patients with localized scleroderma: a phase II study. Arthritis Res Ther. 2015 Jan 28;16(6):510. doi: 10.1186/s13075-014-0510-4.
PubMed 25533576Holland DB, Jeremy AH. The role of inflammation in the pathogenesis of acne and acne scarring. Semin Cutan Med Surg. 2005 Jun;24(2):79-83. doi: 10.1016/j.sder.2005.03.004.
PubMed 16092795
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular and Clinical Study of the Effect of Zaxcell Versus Effezel in the Inflammatory and Scarring Process of Moderate and Severe Acne
- ClinicalTrials.gov ID
- NCT03076320
- Acronym / sponsor ID
- IBMMTG 15-02
- Keywords
- Modified diallyl disulfide oxide (M-DDO), Pirfenidone (PFD), Adapalene + Benzoyl peroxide (A-BPO)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University of GuadalajaraUniversity, hospital or other
- Collaborators
- Hospital Civil de Guadalajara, Cell Pharma
- Study start
- 27 Mar 2017 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 10 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Acne vulgaris is a complex skin disorder involving multiple abnormalities of the pilosebaceous unit. Acne is the most common skin disease during puberty and worsens throughout adolescence. However, epidemiological studies suggest that acne can arise at any age, most frequently affecting individuals between puberty and 30 years of age, with 79%-95% of subjects aged between 16 years and 18 years and 80% of subjects between puberty and 30 years of age. Acne is considered the main reason for consultation with the dermatologist in institutional and private clinical practice.
Clinical features include seborrhoea, non-inflammatory lesions, inflammatory lesions and various degrees of scarring. There are many classifications of acne and scarring severity. Moderate to severe acne is about 15-20%.
Facial acne scarring affects both sexes equally and occurs to some degree in up to 95% of cases. There is a significant correlation between the initial acne grade and the overall severity of scarring at all sites and in both sexes. This would suggest that treatment aimed at reducing the severity of acne might reduce the incidence of scarring. Both superficial inflammatory acne lesions as well as deep nodular lesions seem capable of producing scars.
Conventional therapies recommended for the treatment of acne vulgaris include retinoids, benzoyl peroxide (BPO), antibiotics, and hormonal therapy. Combination therapy using agents with complementary mechanisms provides the opportunity to target multiple pathogenetic causes of acne vulgaris.
The combination in gel with 0.1% adapalene and 2.5% BPO is a once-daily treatment of acne vulgaris. In several double- blind, randomized controlled trials (RCTs), the Adapalene-BPO (A-BPO) combination therapy applied once daily for 12 weeks significantly reduced the number of both inflammatory and non-inflammatory lesions in subjects with moderate acne vulgaris. In Mexico there is an available commercial product of this combination (Effezel®; Galderma). The limitation of this topical therapy is the low tolerability by patients as they can experiment several levels of irritation, erythema, dryness, desquamation, burning, and itching), and patients are advised to expect these side effects, which contribute to discontinue therapy if it becomes severe.
On the other hand, 5-methyl-1-phenyl-2-(1h)-pyridone or pirfenidone (PFD) is a wide-spectrum antifibrotic drug that modulates diverse cytokines action, involving TGF-β, TNF-α, epidermal growth factor, platelet-derived growth factor, VEGF, IGF-1, fibroblast growth factor, interferon-γ, interleukin (IL)-1, IL-6, and IL-8 and it has shown promising effects in vitro and in vivo settings. Also, PFD has proven effective in the prevention and regression of pulmonary fibrosis, peritoneal sclerosis, hepatic cirrhosis, uterine fibromyoma, left ventricular fibrosis, renal interstitial fibrosis, and breast capsular contracture in experimental models. A recently open phase II clinical trial evaluated the therapeutic use of PFD gel in localized scleroderma. Results showed it acts on both the inflammatory and the fibrotic phases.
The other component of Zaxcell is modified-diallyl disulfide oxide (M-DDO) an antimicrobial and antiseptic agent, which has been proved in patients with chronic diabetic ulcer as a potent germicide and has show to increase the beneficial effect of PFD preventing infections, accelerating and improving ulcer resolution. (Observations not published).
According to this, the investigators believe that Zaxcell (PFD + M-DDO) could play an important role in the modulation of inflammatory and scarring process in acne. The investigators hypothesis is that PFD in patients with moderate to severe acne modulates amplification of the inflammatory response, regulating the inflammasome activation, macrophage polarization and its activity in regulating the wound healing process of the skin in an early fashion.
Zaxcell is an innovative gel with a synergetic mode of action that could modulate the inflammatory response. Furthermore, has antiseptic properties and regulates the process of wound healing, fibrogenic and scarring process. In vitro and in vivo studies provide an initial body of evidence on the safety and clinical benefits of PFD, the main component of Zaxcell as a promising candidate for the treatment of moderate to severe acne.
Detailed description
Participants will be randomized using a random number table to distribute in the control (Effezel) and the experimental group (Pirfenidone+M-DDO). Before screening, participants will undergo an informed consent process and they will sign an institutional review board-approved informed consent form. The study will be conducted in accordance with Good Clinical Practices and the principles that have their origins in the Declaration of Helsinki (revised Seoul, Korea, 2008). Potential subjects with acne scars will be selected from the investigators practices and solicited from advertisements. To be included, subjects must have met the inclusion criteria. Demographics data and medical history will be registered on a monthly basis. Before treatment, all subjects with inflammation and scars will be evaluated in the face and back area using the Investigator´s Global Assessment scale (IGA scale) and all the lesions will be counted. The face and back area affected will be mapped and photographed. Participants in the experimental group will receive topical Zaxcell (Pirfenidone 10% +M-DDO gel) two times a day on the face and superior back and patients in control group will receive Effezel (Adapalene 0.1%+Benzoyl peroxide 2.5%) once a day. Both groups will apply the topical treatment in acne on the face and superior back area for six months previous cleansing of the area with neutral soap. Two biopsies of skin will be taken at the beginning, at month one and month 3 from the back area where the treatment will be applied. After this time, only clinical evaluations and photographs will be performed. Participants will be evaluated at every month until 6 months after their last application.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PFD+M-DDO | Experimental | Combination Product: PDF+M-DDOPirfenidone with M-DDO Active ingredients: Pirfenidone 10% with modified oxide diallyl disulfide (M-DDO) 0.016% Dosage form: gel. Dosage: standard finger tip unit (0.5g for an area of 100 to 120 square centimeters). Frequency an duration: topically applied every 12 hours for 6 months. |
| A+PBO | Active comparator | Combination Product: A+PBOAdapalene with benzoyl peroxide Active ingredients: 0.1% Adapalene with 2.5% benzoyl peroxide. Dosage form: gel. Dosage: standard finger tip unit (0.5g for an area of 100 to 120 square centimeters). Frequency and duration: topically applied every 12 hours for 6 month |
Who may qualify
- Ages
- 12 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- Subjects of both genders male or female of any race, 12 to 25 years or age.
- Subjects with a clinical diagnosis of acne vulgaris with facial and back involvement.
- Subjects with a minimum of 20 but not more tan 150 inflammatory lesions on the face (including the nose)
- Subjects with a minimum of 30 but no more 200 non-inflammatory lesions on the face (including the nose)
- Subjects with minimum of 20 but no more than 250 inflammatory lesions on the superior back area.
Key exclusion criteria (10 listed)
- Acne conglobata, acne fulminans, secondary acne.
- Subjects with another chronic inflammatory disease of the skin.
- Subjects with severe acne requiring isotretinoin therapy or other dermatological conditions, which might, in the opinion of the Investigator, interfere with the study evaluation or pose a risk to patient safety during the study.
- Pregnancy, nursing or planning a pregnancy.
- Men with facial hair that would interfere with the assessments.
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 |
|---|---|---|
| PDF+M-DDOAlso: Zaxcell, 5-methyl-phenyl-2(1h)- pyridone with M-DDOParticipants with moderate and severe acne will be treated two times a day on the face and superior back with a smooth layer (standard finger tip unit 0.5 g for an area of 100 to 120 square centimeters) of Zaxcell (Pirfenidone with M-DDO) in form of a gel. Patients have to wait 20 min without cover those sites. | Combination product | PFD+M-DDO |
| A+PBOAlso: Effezel, Adapalene with benzoyl peroxideParticipants with moderate and severe acne will be treated once a day (at night) on the face and superior back with a smooth layer (standard finger tip unit 0.5 g for an area of 100 to 120 square centimeters) of Effezel (Adapalene with benzoyl peroxide) in form of a gel. Patients have to wait 20 min without cover those sites | Combination product | A+PBO |
Primary outcome
Assessing change of lesions with IGA scale (Investigators' Global Assessment)
Time frame: 1, 2, 3, 4, 5 and 6 months
Number or lesions
3 secondary outcomes
Histopathological modification on the inflammatory lesions and improvement in the scarring process
Time frame: 1 and 3 months
2. Expression levels of key molecules involved in acne inflammation and scar remodeling
Time frame: 1 and 3 months
Photonumeric scale
Time frame: 1, 3 and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2023.
- Background: PubMed 18717602Gollnick HP, Finlay AY, Shear N; Global Alliance to Improve Outcomes in Acne. Can we define acne as a chronic disease? If so, how and when? Am J Clin Dermatol. 2008;9(5):279-84. doi: 10.2165/00128071-200809050-00001.
- Background: PubMed 15920154Kang S, Cho S, Chung JH, Hammerberg C, Fisher GJ, Voorhees JJ. Inflammation and extracellular matrix degradation mediated by activated transcription factors nuclear factor-kappaB and activator protein-1 in inflammatory acne lesions in vivo. Am J Pathol. 2005 Jun;166(6):1691-9. doi: 10.1016/s0002-9440(10)62479-0.
- Background: PubMed 20809935Macias-Barragan J, Sandoval-Rodriguez A, Navarro-Partida J, Armendariz-Borunda J. The multifaceted role of pirfenidone and its novel targets. Fibrogenesis Tissue Repair. 2010 Sep 1;3:16. doi: 10.1186/1755-1536-3-16.
- Background: PubMed 24648685Zhou R, Jiang X. Effects of adapalene-benzoyl peroxide combination gel in treatment or maintenance therapy of moderate or severe acne vulgaris: a meta-analysis. Ann Dermatol. 2014 Feb;26(1):43-52. doi: 10.5021/ad.2014.26.1.43. Epub 2014 Feb 17.
- Background: PubMed 25533576Rodriguez-Castellanos M, Tlacuilo-Parra A, Sanchez-Enriquez S, Velez-Gomez E, Guevara-Gutierrez E. Pirfenidone gel in patients with localized scleroderma: a phase II study. Arthritis Res Ther. 2015 Jan 28;16(6):510. doi: 10.1186/s13075-014-0510-4.
- Background: PubMed 16092795Holland DB, Jeremy AH. The role of inflammation in the pathogenesis of acne and acne scarring. Semin Cutan Med Surg. 2005 Jun;24(2):79-83. doi: 10.1016/j.sder.2005.03.004.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing PDF+M-DDO and A+PBO in people with Acne Vulgaris Superficial Mixed Comedonal and Inflammatory, run by University of Guadalajara at 1 site in Mexico.
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 11 inclusion and 10 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 6 Jul 2023. 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 Mexico. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Assessing change of lesions with IGA scale (Investigators' Global Assessment) (time frame: 1, 2, 3, 4, 5 and 6 months). 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 NCT03076320, which also lists 6 linked publications.
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 6 Jul 2023; AzTrials last refreshed its copy on 6 Nov 2026.