Acne VulgarisNCT07054398
Assessment of Serum Catestatin Level in Acne Vulgaris Patients
A study testing Isotretinoin in people with Acne Vulgaris, run by Aswan University at 1 site in Egypt.
Trial summary
Acne vulgaris is a persistent inflammatory condition of the pilosebaceous unit, affecting 85% of people between the ages of 12 and 24, it is regarded as one of the most common diseases in teenagers and young adults. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Isotretinoin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jan 2025to 10 Jan 2026
- Phase
- Interventional
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy persons of both sexes with moderate and severe acne.
Who cannot join
- Pregnant and lactating women.
- Immunocompromised patients.
- Severe anemia.
- History of chronic liver disease.
- Hyperlipidemia
- Non-inflammatory acne conditions.
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- History of neurologic disorders.
- History of neoplastic disorders.
- History of cardiac disease.
- History of systemic acne treatment for at least 4 weeks prior to inclusion and no topical treatments for at least 2 weeks.
- Cases with known hypersensitivity reaction to isotretinoin.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Aswan Unuversity Hospital
Aswān
Mahmoud Ahmed Ali, M.D, +201002364902, dr.mahmoudali@aswu.edu.eg
Mohamed Amer Ahmed Abdellatif, M.D, +201060394083, mohammed.abdellatif@aswu.edu.eg
About this study
Official title: Assessment of Serum Catestatin Level in Acne Vulgaris Patients Before and After Treatment With Oral Isotretinoin
Acne vulgaris is a persistent inflammatory condition of the pilosebaceous unit, affecting 85% of people between the ages of 12 and 24, it is regarded as one of the most common diseases in teenagers and young adults.
Catestatin, a peptide derived from chromogranin A (CgA), was first discovered in 1997 as an acute nicotinic-cholinergic antagonist. Later, it was determined that CST is a pleiotropic hormone.
Read the detailed description
Acne vulgaris is a persistent inflammatory condition of the pilosebaceous unit, affecting 85% of people between the ages of 12 and 24, it is regarded as one of the most common diseases in teenagers and young adults.
Four factors are thought to be linked to the physiopathology of acne: changes in the keratinization process of corneocytes, which results in the development of comedones; follicular proliferation of the bacterium Cutibacterium acnes; increased production of inflammatory mediators, including interleukins (IL)-1β; and increased sebum production by the sebaceous gland.
The distinctive lesions can be classified as either inflammatory (papules, pustules, nodules, and cysts) or non-inflammatory (open/black and closed/white comedones). Both types of lesions cause skin pigmentation and scarring, which need consistent treatment. Lesions are usually found on the chest, upper back, neck, and face.
There are wide variety of topical and oral therapy methods can be used for acne treatment. Topical retinoids, benzoyl peroxide, azelaic acid, and their combinations are considered first-line agents. Oral drugs such as oral antibiotics, isotretinoin, or hormonal therapy may be used to treat refractory or more severe acne.
The most effective treatment for acne is still isotretinoin (13-cis-retinoic acid), an oral retinoid that was licensed in 1982 for the treatment of acne vulgaris. Multiple randomized controlled trials have confirmed that it is more effective than oral antibiotics and placebos at reducing the number of acne lesions.
Oral isotretinoin is the only medication that can cure or prolong remission of moderate to severe acne , avoiding scarring and psychological effects. isotretinoin reduces the size of sebaceous glands, lowers sebum excretion, regulates cell proliferation, decreases keratinization, and modifies the follicles' microenvironment , resulting in a decrease in the number of Cutibacterium acnes. Furthermore, it has immunomodulatory and anti-inflammatory qualities by lowering the expression of monocyte TLR-2, lowering the inflammatory cytokine response, and having anti-neoplastic effects.
Antimicrobial peptides (AMP) have a wide spectrum of antibacterial and immunomodulatory properties against bacteria (Gram positive and Gram negative), viruses and fungi.
Variations in AMP expression in the skin could play a significant role in the pathogenesis of numerous skin conditions, such as acne vulgaris.
Catestatin, a peptide derived from chromogranin A (CgA), was first discovered in 1997 as an acute nicotinic-cholinergic antagonist. Later, it was determined that CST is a pleiotropic hormone.
Catestatin (CST), a versatile 21 amino acid long cationic peptide, derived from the processing of chromogranin A, catestatin is produced by chromaffin cells and neutrophils , retained in chromaffin granules, and produced in the skin upon damage.
Catestatin affects innate immunity, inflammation, blood pressure regulation, and catecholamine inhibition.
- Conditions
- Acne Vulgaris
- Being tested
- Isotretinoin
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IsotretinoinDrug
Also called Catestatin
- Measure the serum levels of catestatin in patients with moderate and severe acne vulgaris versus healthy control persons.
- Evaluate the effect of oral isotretinoin treatment on serum catestatin levels in patients with moderate and severe acne vulgaris.
| Study group | Role | What they receive |
|---|---|---|
| Group I (Study Group) | Active comparator | About 30 patients suffering from moderate and severe acne Vulgaris Receives: Drug: Isotretinoin |
| Group II (Control Group) | Placebo comparator | About 30 Healthy persons Receives: Drug: Isotretinoin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evalaute serum level of Catestatin in acne patient
Assessment of clinical improvement according to:(8) G4(excellent:100% reduction) G3(good:75-99% reduction) G2(moderate: 50-74% reduction) G1(insufficient :1-49% reduction) G0(unchanged) G-1(worse)
Measured: 12 weeks
Evalaute the effect of treatment with systemic isotretinon
Evaluate the effect of treatment with systemic isotretinon therapy (0.5 mg/kg/day, up to 40 mg daily) on the level of serum Catestatin on the Participants whom suffering from Acne Vulgaris whether moderate or severe.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start10 Jan 2025
- Primary completion1 Jan 2026 (estimated)
- Study completion10 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aswan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona Zakaria Mohamed, Aswan University
- Investigators
- Moustafa Adam Ali El Taieb, Professor, Study chair, Dermatology, Venereology and Andrology. Faculty of Medicine,Aswan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07054398
- Sponsor's protocol ID
- Serum Catestatin
- Status last verified
- Jan 2025
- First submitted
- 15 May 2025
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Serum Catestatin Level in Acne Vulgaris Patients Before and After Treatment With Oral Isotretinoin
- ClinicalTrials.gov ID
- NCT07054398
- Acronym / sponsor ID
- Serum Catestatin
- Conditions
- Acne Vulgaris
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Aswan UniversityUniversity, hospital or other
- Study start
- 10 Jan 2025 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 10 Jan 2026 (estimated)
- First posted
- 8 Jul 2025 (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 persistent inflammatory condition of the pilosebaceous unit, affecting 85% of people between the ages of 12 and 24, it is regarded as one of the most common diseases in teenagers and young adults.
Catestatin, a peptide derived from chromogranin A (CgA), was first discovered in 1997 as an acute nicotinic-cholinergic antagonist. Later, it was determined that CST is a pleiotropic hormone.
Detailed description
Acne vulgaris is a persistent inflammatory condition of the pilosebaceous unit, affecting 85% of people between the ages of 12 and 24, it is regarded as one of the most common diseases in teenagers and young adults.
Four factors are thought to be linked to the physiopathology of acne: changes in the keratinization process of corneocytes, which results in the development of comedones; follicular proliferation of the bacterium Cutibacterium acnes; increased production of inflammatory mediators, including interleukins (IL)-1β; and increased sebum production by the sebaceous gland.
The distinctive lesions can be classified as either inflammatory (papules, pustules, nodules, and cysts) or non-inflammatory (open/black and closed/white comedones). Both types of lesions cause skin pigmentation and scarring, which need consistent treatment. Lesions are usually found on the chest, upper back, neck, and face.
There are wide variety of topical and oral therapy methods can be used for acne treatment. Topical retinoids, benzoyl peroxide, azelaic acid, and their combinations are considered first-line agents. Oral drugs such as oral antibiotics, isotretinoin, or hormonal therapy may be used to treat refractory or more severe acne.
The most effective treatment for acne is still isotretinoin (13-cis-retinoic acid), an oral retinoid that was licensed in 1982 for the treatment of acne vulgaris. Multiple randomized controlled trials have confirmed that it is more effective than oral antibiotics and placebos at reducing the number of acne lesions.
Oral isotretinoin is the only medication that can cure or prolong remission of moderate to severe acne , avoiding scarring and psychological effects. isotretinoin reduces the size of sebaceous glands, lowers sebum excretion, regulates cell proliferation, decreases keratinization, and modifies the follicles' microenvironment , resulting in a decrease in the number of Cutibacterium acnes. Furthermore, it has immunomodulatory and anti-inflammatory qualities by lowering the expression of monocyte TLR-2, lowering the inflammatory cytokine response, and having anti-neoplastic effects.
Antimicrobial peptides (AMP) have a wide spectrum of antibacterial and immunomodulatory properties against bacteria (Gram positive and Gram negative), viruses and fungi.
Variations in AMP expression in the skin could play a significant role in the pathogenesis of numerous skin conditions, such as acne vulgaris.
Catestatin, a peptide derived from chromogranin A (CgA), was first discovered in 1997 as an acute nicotinic-cholinergic antagonist. Later, it was determined that CST is a pleiotropic hormone.
Catestatin (CST), a versatile 21 amino acid long cationic peptide, derived from the processing of chromogranin A, catestatin is produced by chromaffin cells and neutrophils , retained in chromaffin granules, and produced in the skin upon damage.
Catestatin affects innate immunity, inflammation, blood pressure regulation, and catecholamine inhibition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (Study Group) | Active comparator | Drug: IsotretinoinAbout 30 patients suffering from moderate and severe acne Vulgaris |
| Group II (Control Group) | Placebo comparator | Drug: IsotretinoinAbout 30 Healthy persons |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy persons of both sexes with moderate and severe acne.
Key exclusion criteria (11 listed)
- Pregnant and lactating women.
- Immunocompromised patients.
- Severe anemia.
- History of chronic liver disease.
- Hyperlipidemia
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: Catestatin* Measure the serum levels of catestatin in patients with moderate and severe acne vulgaris versus healthy control persons. * Evaluate the effect of oral isotretinoin treatment on serum catestatin levels in patients with moderate and severe acne vulgaris. | Drug | Group I (Study Group), Group II (Control Group) |
Primary outcome
Evalaute serum level of Catestatin in acne patient
Time frame: 12 weeks
Assessment of clinical improvement according to:(8) G4(excellent:100% reduction) G3(good:75-99% reduction) G2(moderate: 50-74% reduction) G1(insufficient :1-49% reduction) G0(unchanged) G-1(worse)
Evalaute the effect of treatment with systemic isotretinon
Time frame: 12 weeks
Evaluate the effect of treatment with systemic isotretinon therapy (0.5 mg/kg/day, up to 40 mg daily) on the level of serum Catestatin on the Participants whom suffering from Acne Vulgaris whether moderate or severe.
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 8 Jul 2025.
- Individual participant dataSharing planned: Undecided
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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.
Moustafa Adam Ali El Taieb, Professor study chair
Dermatology, Venereology and Andrology. Faculty of Medicine,Aswan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isotretinoin in people with Acne Vulgaris, run by Aswan University at 1 site in Egypt.
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 11 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: looking for participants now, as of the sponsor's last update on 8 Jul 2025. 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 Egypt. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Mona Zakaria Mohamed, MSc (+201142550119, mona1704213@aswu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evalaute serum level of Catestatin in acne patient (time frame: 12 weeks). The study lists 2 primary outcomes in all. 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 8 Jul 2025.