Acneiform Drug EruptionPhase 2PNOC039NCT07629167
Isotretinoin vs. Doxycycline for Acneiform Rash in Patients Receiving Drugs That Target the MAPK Pathway
A Phase 2 study testing Isotretinoin, Doxycycline and Blood specimen collection in people with Acneiform Drug Eruption and Acneiform Eruptions, run by University of California, San Francisco at 1 site in United States.
Trial summary
A phase 2 study testing the efficacy of isotretinoin versus doxycycline in treating participants who develop a acneiform rash caused by standard of care, tumor-directed therapies targeting the mitogenactivated protein kinase (MAPK) pathway. Read more about this study
- Who is it for?
- Ages 12 to 39 years
- Conditions the study is for
- Acneiform Drug Eruption, Acneiform Eruptions
- What is being tested?
- Isotretinoin, Doxycycline and Blood specimen collection
- Type of treatment
- Pill or oral medicine, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2026to 30 Mar 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 39 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Participants must have developed either a grade 2, 3, or 4 rash categorized as acneiform while taking tumor-directed therapy that targets the MAPK pathway.
- Acneiform rash will be defined according to CTCAE v5.0 as a disorder characterized by an eruption of papules and pustules, typically appearing in face, scalp, upper chest and back.
- Grade 2 = Papules and/or pustules covering 10-30% body surface area (BSA), which may or may not be associated with symptoms or of pruritus or tenderness; associated with psychosocial impact; limiting instrumental Activities of Daily Living (ADL); papules and/or pustules covering > 30% BSA with or without mild symptoms.
- Grade 3 = Papules and/or pustules covering > 30% BSA with moderate or severe symptoms; limiting self-care ADL; associated with local superinfection with oral antibiotics indicated.
- Grade 4 = Life-threatening consequences; papules and/or pustules covering any % BSA, which may or may not be associated with symptoms of pruritus or tenderness and are associated with extensive superinfection with IV antibiotics indicated.
- Prior Therapy: Participants may have received either doxycycline or isotretinoin in the past for treatment of their targeted therapy induced rash or acne. However, if they took doxycycline or another tetracycline antibiotic for a rash caused by a targeted therapy or for acne, the last dose must have been at least 4 weeks before study registration. If a participant took isotretinoin for any reason, the last dose must be at least 6 months prior to study registration.
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- Age. 12-39 years old.
- Organ Function Requirements.
- Adequate Liver Function Defined as:
- Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age; in presence of Gilbert's syndrome, total bilirubin < 3 x ULN or direct bilirubin < 1.5 x ULN
- alanine aminotransferase (ALT) ≤ 3 x ULN
- aspartate aminotransferase (AST) ≤ 3 x ULN.
- Serum triglycerides < 500 mg/dL or < 5.7 mmol/L
- Due to the harmful effects of isotretinoin and doxycycline on the developing human fetus women of child-bearing potential and men must agree to use adequate contraception (as recommended by the iPLEDGE system if residing in the United States for those who will take isotretinoin) prior to study entry, for the duration of study participation, and one (1) month after completion of isotretinoin and doxycycline administration. If a participant requires contraception, they will require two forms of contraception as outlined by the iPLEDGE system. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. The proper steps in the iPLEDGE system must also be taken.
- Participants must be able and willing to take a gelatin capsule.
- Participants must be able to swallow pills.
- A legal parent/guardian or participant must be able to understand, and willing to sign, a written informed consent and assent document, as appropriate.
Who cannot join
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to doxycycline or isotretinoin, or other agents used in study. Participants also must not have a paraben allergy.
- Participants taking any medications listed must be discussed with study chair(s).
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, other than skin infection in setting of rash.
- Women of childbearing potential must not be pregnant or breast-feeding.
- Participants who report active suicidal ideation due to isotretinoin's black box warning.
- Participants who refuse to be photographed for the centralized dermatology review.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
PNOC Operations Office, 877-827-3222, PNOC039@ucsf.edu
Sabine Mueller, MD, PhD, MAS
About this study
Official title: A Phase 2 Study of Isotretinoin vs. Doxycycline for Acneiform Rash in Patients Receiving Drugs That Target the MAPK Pathway
A phase 2 study testing the efficacy of isotretinoin versus doxycycline in treating participants who develop a acneiform rash caused by standard of care, tumor-directed therapies targeting the mitogenactivated protein kinase (MAPK) pathway.
Read the detailed description
PRIMARY OBJECTIVES:
- To compare the efficacy of the isotretinoin and doxycycline after 12 weeks of therapy in patients who develop an acneiform rash caused by a MAPK pathway-inhibitor, measured by the NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
EXPLORATORY OBJECTIVES:
- To assess feasibility of a centralized dermatology review to confirm rash grading and response to treatment.
- The participants' Multinational Association of Supportive Care in Cancer (MASCC) Epidermal Growth Factor Receptor Inhibitors (EGFRI) Skin Toxicity Tool (MESST) scores will be compared to CTCAE grading.
- To measure time to rash response by comparing CTCAE rash grading.
- To measure the change in quality-of-life scores from baseline to after 12 weeks of doxycycline or isotretinoin therapy using the Children's Dermatology Life Quality Index (CDLQI) and Dermatology Life Quality Index (DLQI).
- To record adverse events caused by doxycycline or isotretinoin and any cutaneous adverse events thought to be caused by the targeted agent per CTCAE v5.0.
- To characterize cutaneous toxicities across participants with different skin colors and tones.
- To measure the frequency of dose alterations in the MAPK inhibitor and then compare between the two study arms.
- To evaluate the number of participants who require retreatment for a rash 3 months after stopping study treatment.
- To describe the microbiome profile in participants receiving doxycycline and isotretinoin.
OUTLINE:
Participants will be randomized to receive 12 weeks of isotretinoin or doxycycline. Participants are followed at the end of treatment, day 30, 3 months and 6 months after treatment.
- Conditions
- Acneiform Drug Eruption, Acneiform Eruptions
- Being tested
- Isotretinoin, Doxycycline, Blood specimen collection, Photographs of Rash, Questionnaires
- Keywords
- Mitogen-Activated Protein Kinase (MAPK) Pathway, Cutaneous Adverse Events, Supportive Care
- Medical subject headings
- Acneiform Eruptions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IsotretinoinDrug
Also called Accutane
Given Orally
DoxycyclineDrug
Also called Vibramycin, Doryx
Given Orally
Blood specimen collectionProcedure or surgery
Also called Blood sample collection
Perform blood draw
Photographs of RashOther
Undergo photography
QuestionnairesBehavioural
Also called Health-Related Quality of Life Questionnaires
Participants will be asked to complete questionnaires
Stool Specimen collectionProcedure or surgery
Also called Stool Sample collection
Perform stool sample collection
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Isotretinoin | Experimental | Participants randomized to the isotretinoin arm will be enrolled in the iPLEDGE program prior to treatment initiation. Female participants of childbearing potential will undergo a urine or serum pregnancy test as required for iPLEDGE registration. Participants will receive oral isotretinoin daily at a dose based on body weight, ranging from 10 mg to 40 mg, for up to 12 weeks. Treatment will consist of three consecutive 28-day cycles.
Participants will undergo follow-up at the end of treatment and at 30 days, 3 months, and 6 months after treatment completion for safety monitoring and post-treatment assessments, until withdrawal from the study or death, whichever occurs first. Receives: Drug: Isotretinoin; Procedure: Blood specimen collection; Other: Photographs of Rash; Behavioral: Questionnaires; Procedure: Stool Specimen collection |
| Arm B: Doxycycline | Experimental | Participants randomized to the doxycycline arm will receive oral doxycycline daily at a body weight-based dose of 50 mg or 100 mg for up to 12 weeks. Treatment will consist of three consecutive 28-day cycles. Participants will undergo follow-up at the end of treatment and at 30 days, 3 months, and 6 months after treatment completion for safety monitoring and post-treatment assessments, until withdrawal from the study or death, whichever occurs first. Receives: Drug: Doxycycline; Procedure: Blood specimen collection; Other: Photographs of Rash; Behavioral: Questionnaires; Procedure: Stool Specimen collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants who experienced acneiform rash
The proportion of participants who experience a Grade < 2 acneiform rash at week 12 while receiving non-investigational treatment for cancer that targets the mitogen activated protein kinase (MAPK) pathway as classified by the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE version 5.0) and 95% confidence interval will be reported.
Measured: Up to 12 weeks following treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start30 Aug 2026 (estimated)
- Primary completion30 Aug 2029 (estimated)
- Study completion30 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acneiform Drug EruptionStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Day One Biopharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Sabine Mueller, MD, PhD, MAS, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07629167
- Sponsor's protocol ID
- 250833
- Other IDs
- NCI-2026-04129
- Acronym
- PNOC039
- Status last verified
- May 2026
- First submitted
- 1 Jun 2026
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified datasets may be shared with research collaborators during the course of the study.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Isotretinoin vs. Doxycycline for Acneiform Rash in Patients Receiving Drugs That Target the MAPK Pathway
- ClinicalTrials.gov ID
- NCT07629167
- Acronym / sponsor ID
- PNOC039 / 250833
- Conditions
- Acneiform Drug Eruption, Acneiform Eruptions
- Keywords
- Mitogen-Activated Protein Kinase (MAPK) Pathway, Cutaneous Adverse Events, Supportive Care
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Day One Biopharmaceuticals, Inc.
- Study start
- 30 Aug 2026 (estimated)
- Primary completion
- 30 Aug 2029 (estimated)
- Study completion
- 30 Mar 2030 (estimated)
- First posted
- 5 Jun 2026 (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.
A phase 2 study testing the efficacy of isotretinoin versus doxycycline in treating participants who develop a acneiform rash caused by standard of care, tumor-directed therapies targeting the mitogenactivated protein kinase (MAPK) pathway.
Detailed description
PRIMARY OBJECTIVES:
- To compare the efficacy of the isotretinoin and doxycycline after 12 weeks of therapy in patients who develop an acneiform rash caused by a MAPK pathway-inhibitor, measured by the NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
EXPLORATORY OBJECTIVES:
- To assess feasibility of a centralized dermatology review to confirm rash grading and response to treatment.
- The participants' Multinational Association of Supportive Care in Cancer (MASCC) Epidermal Growth Factor Receptor Inhibitors (EGFRI) Skin Toxicity Tool (MESST) scores will be compared to CTCAE grading.
- To measure time to rash response by comparing CTCAE rash grading.
- To measure the change in quality-of-life scores from baseline to after 12 weeks of doxycycline or isotretinoin therapy using the Children's Dermatology Life Quality Index (CDLQI) and Dermatology Life Quality Index (DLQI).
- To record adverse events caused by doxycycline or isotretinoin and any cutaneous adverse events thought to be caused by the targeted agent per CTCAE v5.0.
- To characterize cutaneous toxicities across participants with different skin colors and tones.
- To measure the frequency of dose alterations in the MAPK inhibitor and then compare between the two study arms.
- To evaluate the number of participants who require retreatment for a rash 3 months after stopping study treatment.
- To describe the microbiome profile in participants receiving doxycycline and isotretinoin.
OUTLINE:
Participants will be randomized to receive 12 weeks of isotretinoin or doxycycline. Participants are followed at the end of treatment, day 30, 3 months and 6 months after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Isotretinoin | Experimental | Drug: Isotretinoin, Procedure: Blood specimen collection, Other: Photographs of Rash, Behavioral: Questionnaires, Procedure: Stool Specimen collectionParticipants randomized to the isotretinoin arm will be enrolled in the iPLEDGE program prior to treatment initiation. Female participants of childbearing potential will undergo a urine or serum pregnancy test as required for iPLEDGE registration. Participants will receive oral isotretinoin daily at a dose based on body weight, ranging from 10 mg to 40 mg, for up to 12 weeks. Treatment will consist of three consecutive 28-day cycles. Participants will undergo follow-up at the end of treatment and at 30 days, 3 months, and 6 months after treatment completion for safety monitoring and post-treatment assessments, until withdrawal from the study or death, whichever occurs first. |
| Arm B: Doxycycline | Experimental | Drug: Doxycycline, Procedure: Blood specimen collection, Other: Photographs of Rash, Behavioral: Questionnaires, Procedure: Stool Specimen collectionParticipants randomized to the doxycycline arm will receive oral doxycycline daily at a body weight-based dose of 50 mg or 100 mg for up to 12 weeks. Treatment will consist of three consecutive 28-day cycles. Participants will undergo follow-up at the end of treatment and at 30 days, 3 months, and 6 months after treatment completion for safety monitoring and post-treatment assessments, until withdrawal from the study or death, whichever occurs first. |
Who may qualify
- Ages
- 12 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (17 listed)
- Participants must have developed either a grade 2, 3, or 4 rash categorized as acneiform while taking tumor-directed therapy that targets the MAPK pathway.
- Prior Therapy: Participants may have received either doxycycline or isotretinoin in the past for treatment of their targeted therapy induced rash or acne. However, if they took doxycycline or another tetracycline antibiotic for a rash caused by a targeted therapy or for acne, the last dose must have been at least 4 weeks before study registration. If a participant took isotretinoin for any reason, the last dose must be at least 6 months prior to study registration.
- Age. 12-39 years old.
- Organ Function Requirements.
- Due to the harmful effects of isotretinoin and doxycycline on the developing human fetus women of child-bearing potential and men must agree to use adequate contraception (as recommended by the iPLEDGE system if residing in the United States for those who will take isotretinoin) prior to study entry, for the duration of study participation, and one (1) month after completion of isotretinoin and doxycycline administration. If a participant requires contraception, they will require two forms of contraception as outlined by the iPLEDGE system. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. The proper steps in the iPLEDGE system must also be taken.
Key exclusion criteria (6 listed)
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to doxycycline or isotretinoin, or other agents used in study. Participants also must not have a paraben allergy.
- Participants taking any medications listed must be discussed with study chair(s).
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, other than skin infection in setting of rash.
- Women of childbearing potential must not be pregnant or breast-feeding.
- Participants who report active suicidal ideation due to isotretinoin's black box warning.
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 |
|---|---|---|
| IsotretinoinAlso: AccutaneGiven Orally | Drug | Arm A: Isotretinoin |
| DoxycyclineAlso: Vibramycin, DoryxGiven Orally | Drug | Arm B: Doxycycline |
| Blood specimen collectionAlso: Blood sample collectionPerform blood draw | Procedure or surgery | Arm A: Isotretinoin, Arm B: Doxycycline |
| Photographs of RashUndergo photography | Other | Arm A: Isotretinoin, Arm B: Doxycycline |
| QuestionnairesAlso: Health-Related Quality of Life QuestionnairesParticipants will be asked to complete questionnaires | Behavioural | Arm A: Isotretinoin, Arm B: Doxycycline |
| Stool Specimen collectionAlso: Stool Sample collectionPerform stool sample collection | Procedure or surgery | Arm A: Isotretinoin, Arm B: Doxycycline |
Primary outcome
Proportion of Participants who experienced acneiform rash
Time frame: Up to 12 weeks following treatment
The proportion of participants who experience a Grade < 2 acneiform rash at week 12 while receiving non-investigational treatment for cancer that targets the mitogen activated protein kinase (MAPK) pathway as classified by the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE version 5.0) and 95% confidence interval will be reported.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Individual participant dataSharing planned: Yes. De-identified datasets may be shared with research collaborators during the course of the study.
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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.
Sabine Mueller, MD, PhD, MAS principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Isotretinoin, Doxycycline and Blood specimen collection in people with Acneiform Drug Eruption and Acneiform Eruptions, run by University of California, San Francisco 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 17 inclusion and 6 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: opening soon, as of the sponsor's last update on 5 Jun 2026. 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jannerfer An (877-827-3222, PNOC039@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants who experienced acneiform rash (time frame: Up to 12 weeks following treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jun 2026.