Acne VulgarisPhase 2NCT07473895
Topical 5% Spironolactone Gel Versus 0.1% Adapalene Gel for Acne Vulgaris: A Randomized Split-Face Study
A Phase 2 study testing Spironolactone 5% Topical Gel and Adapalene 0.1% Topical Gel in people with Acne Vulgaris, run by Assiut University at 1 site in Egypt.
Trial summary
Acne vulgaris is one of the most common dermatological conditions affecting adolescents and young adults. It results from multiple pathogenic factors, including increased sebum production, follicular hyperkeratinization, colonization by Cutibacterium acnes, and inflammation. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Spironolactone 5% Topical Gel and Adapalene 0.1% Topical Gel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- Apr 2026to Dec 2026
- 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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age: 18-45 years old.
- Patients with mild to moderate bilateral acne vulgaris on the face.
- Presence of non-inflammatory acne (open and closed comedones).
- Presence of inflammatory papules and pustules.
Who cannot join
- Pregnancy and lactation.
- Patients taking oral contraceptive pills or any hormonal treatment.
- Patients who were using topical or systemic medications for acne in the last two months prior to starting therapy.
- Patients who had received laser resurfacing, chemical peeling, mesotherapy, or any similar facial interventions.
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
Assiut University
Asyut
Assiut University, 08822080150, vp_grad@aun.edu.eg
About this study
Official title: Efficacy and Safety of Topical 5% Spironolactone Gel Nano-Formulation Versus 0.1% Adapalene Gel in the Management of Acne Vulgaris: A Split-Face Study
Acne vulgaris is one of the most common dermatological conditions affecting adolescents and young adults. It results from multiple pathogenic factors, including increased sebum production, follicular hyperkeratinization, colonization by Cutibacterium acnes, and inflammation. Topical retinoids such as adapalene are widely used as first-line therapy; however, they may cause irritation and are not always effective in all patients. Recently, topical antiandrogen therapies such as spironolactone have gained attention because of their ability to reduce sebum production and improve acne lesions.
This study aims to evaluate the efficacy and safety of a topical 5% spironolactone gel nano-formulation compared with 0.1% adapalene gel in the treatment of acne vulgaris. A split-face study design will be used in which each participant will receive spironolactone gel on one side of the face and adapalene gel on the other side. This design allows each participant to serve as their own control and helps reduce variability in treatment response.
Read more
Participants diagnosed with acne vulgaris will be enrolled and treated for a defined follow-up period. Clinical assessment will be performed at baseline and during scheduled follow-up visits to evaluate improvement in acne lesions and monitor possible adverse effects. The primary outcomes will include changes in acne lesion counts and clinical severity scores. Safety and tolerability of both treatments will also be assessed.
The results of this study may provide evidence regarding the effectiveness of topical spironolactone nano-formulation as a potential alternative or adjunct therapy for acne vulgaris.
Read the detailed description
Acne vulgaris is a chronic inflammatory disorder of the pilosebaceous unit that affects a large proportion of adolescents and young adults worldwide. The condition is characterized by the development of comedones, papules, pustules, and in severe cases nodules and cysts. The pathogenesis of acne involves multiple mechanisms including follicular hyperkeratinization, excessive sebum production stimulated by androgens, colonization with Cutibacterium acnes, and inflammatory responses within the pilosebaceous unit.
Topical retinoids are considered a cornerstone in the management of acne vulgaris due to their comedolytic and anti-inflammatory properties. Adapalene, a third-generation topical retinoid, is commonly used because of its efficacy and relatively favorable tolerability profile. Despite these advantages, some patients experience skin irritation, dryness, and erythema, which may limit adherence and treatment outcomes.
Spironolactone is an antiandrogen medication traditionally used orally for the treatment of hormonal acne, particularly in females. It acts by blocking androgen receptors and reducing sebaceous gland activity, thereby decreasing sebum production. However, systemic administration may be associated with potential adverse effects. Topical formulations of spironolactone have been proposed as an alternative approach to deliver antiandrogen effects locally while minimizing systemic exposure.
Recent advances in pharmaceutical technology, including nano-formulation delivery systems, may enhance the penetration and stability of topical medications and improve therapeutic outcomes. A topical 5% spironolactone gel nano-formulation may provide improved skin penetration and targeted delivery to the pilosebaceous unit.
The present study is designed as a split-face comparative clinical study to evaluate the efficacy and safety of topical 5% spironolactone gel nano-formulation compared with topical 0.1% adapalene gel in patients with acne vulgaris. In this design, each participant will apply spironolactone gel to one side of the face and adapalene gel to the other side according to the study protocol. This approach allows direct comparison of the two treatments within the same individual and minimizes inter-individual variability.
Eligible participants diagnosed with acne vulgaris will be recruited from dermatology clinics. Baseline clinical assessment will include evaluation of acne severity, lesion counts, and skin examination. Participants will receive instructions regarding the application of each topical treatment and follow-up visits will be scheduled throughout the study period to monitor treatment response and detect possible adverse events.
The primary outcome will be the change in acne lesion counts and clinical severity after the treatment period. Secondary outcomes will include evaluation of treatment tolerability, improvement in inflammatory and non-inflammatory lesions, and documentation of local adverse reactions such as erythema, dryness, burning sensation, or irritation.
The findings of this study may contribute to the growing body of evidence regarding topical antiandrogen therapy for acne and may support the use of spironolactone nano-formulation as an effective and safe topical treatment option for patients with acne vulgaris.
- Conditions
- Acne Vulgaris
- Being tested
- Spironolactone 5% Topical Gel, Adapalene 0.1% Topical Gel
- Keywords
- Acne vulgaris, Spironolactone, Adapalene, Topical therapy, Split-face study, Antiandrogen thearapy, Nano-Formulation, Dermatology, Acne treatment
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spironolactone 5% Topical GelDrug
Also called Topical Spironolactone, Spironolactone Nano-Gel, Spironolactone 5% Gel
This is a drug-loaded nanospanlastics dispersion (using Span 60 and Tween 40) fabricated via the ethanol injection technique. It is applied twice daily to one half of the face for 8 weeks.
Adapalene 0.1% Topical GelDrug
Also called Topical Adapalene, Adapalene Gel, Adapalene 0.1%
A third-generation retinoid applied once daily at night to the opposite half of the face.
| Study group | Role | What they receive |
|---|---|---|
| Topical 5% Spironolactone Gel nano-formulation. | Experimental | Participants will apply topical 5% spironolactone nano-formulation gel to one side of the face once daily during the study period to evaluate its efficacy and safety in the treatment of acne vulgaris. Receives: Drug: Spironolactone 5% Topical Gel |
| Topical 0.1% Adapalene Gel | Active comparator | Participants will apply topical 0.1% adapalene gel to the opposite side of the face once daily during the study period for comparison of efficacy and safety. Receives: Drug: Adapalene 0.1% Topical Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the Change in Acne Severity via Global Acne Grading System (GAGS)
The GAGS is used to calculate acne severity separately for each half of the face. The face is divided into regions (forehead, cheeks, nose, chin) with assigned area factors. Each region is graded from 0 (no lesion) to 4 (nodule); the regional score is the product of the most severe lesion grade and the area factor
Measured: Baseline and 8 weeks (end of treatment)
Secondary outcomes (4)
Measure Comparative Change in Global Acne Grading System (GAGS) Score
The difference in acne severity between the two treated sides of the face will be evaluated using the Global Acne Grading System (GAGS). The GAGS assesses acne severity by evaluating six anatomical locations (forehead, right cheek, left cheek, nose, chin, and chest/upper back). Each location is assigned a factor based on surface area and lesion type (comedones, papules, pustules, and nodules).
The total score ranges from 0 to 44, where higher scores indicate more severe acne. The study will compare the reduction in GAGS scores between the facial side treated with topical 5% spironolactone nano-formulation gel and the side treated with topical 0.1% adapalene gel.
Measured: 8 weeks
Measure The Reduction in Total Lesion Count (TLC)
Sum of both inflammatory (papules, pustules) and non-inflammatory (open and closed comedones) lesions on each side of the face.
Measured: Baseline and 8 weeks
Measure Change in Quality of Life Using the Cardiff Acne Disability Index (CADI)
Quality of life will be assessed using the Cardiff Acne Disability Index (CADI), a validated patient-reported questionnaire designed to measure the psychological and social impact of acne. The CADI consists of 5 questions, each scored from 0 to 3, resulting in a total score ranging from 0 to 15.
Higher scores indicate greater impairment in quality of life related to acne. The Arabic validated version of the CADI will be used in this study. Changes in CADI scores will be assessed from baseline to 8 weeks of treatment.
Measured: Baseline and 8 weeks.
Measure Patient Treatment Satisfaction Assessed by the Dermatology Treatment Satisfaction Questionnaire (DermSat-7)
Patient satisfaction with treatment will be assessed using the Dermatology Treatment Satisfaction Questionnaire (DermSat-7). This patient-reported instrument contains 7 items evaluating treatment effectiveness, convenience, tolerability, and overall satisfaction.
Each item is rated on a 5-point Likert scale, resulting in a total score range from 7 to 35. Higher scores indicate greater treatment satisfaction. Scores will be evaluated at the end of the treatment period.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study startApr 2026 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants with acne vulgaris will be enrolled in a split-face comparative study. Each participant will apply topical 5% spironolactone nano-formulation gel to one side of the face and topical 0.1% adapalene gel to the opposite side. This design allows each participant to serve as their own control and enables direct comparison of treatment efficacy and safety between the two topical therapies.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Ahmed Thabet Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07473895
- Sponsor's protocol ID
- AUN-DERM-ACNE-2026
- Status last verified
- Mar 2026
- First submitted
- 11 Mar 2026
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Charakida A, Charakida M, Chu AC. Double-blind, randomized, placebo-controlled study of a lotion containing triethyl citrate and ethyl linoleate in the treatment of acne vulgaris. Br J Dermatol. 2007 Sep;157(3):569-74. doi: 10.1111/j.1365-2133.2007.08083.x. Epub 2007 Jul 16.
PubMed 17635508Elradi M, Hamed DE, Eltwansy MS, Hosny D. The Impact of Acne on Quality of Life: A Cross-Sectional Study from Egypt. Skin Appendage Disord. 2025 Jun;11(3):255-261. doi: 10.1159/000543051. Epub 2024 Dec 10.
PubMed 40475110Bae IH, Kwak JH, Na CH, Kim MS, Shin BS, Choi H. A Comprehensive Review of the Acne Grading Scale in 2023. Ann Dermatol. 2024 Apr;36(2):65-73. doi: 10.5021/ad.23.094.
PubMed 38576244Shields A, Armstrong AW, Kaur MN, Layton A, Thiboutot D, Tan J, Barbieri JS. Evaluation of DermSat-7 for Assessing Treatment Satisfaction in Patients with Acne. JAMA Dermatol. 2024 Jan 1;160(1):88-92. doi: 10.1001/jamadermatol.2023.4481.
PubMed 37991774Althwanay A, AlEdani EM, Kaur H, Kasapoglu M, Yadavalli R, Nawaz S, Nath TS. Efficacy of Topical Treatments in the Management of Mild-to-Moderate Acne Vulgaris: A Systematic Review. Cureus. 2024 Apr 9;16(4):e57909. doi: 10.7759/cureus.57909. eCollection 2024 Apr.
PubMed 38725769Dereiah S, Ghori MU, Conway BR. A Systematic Review of Spironolactone Nano-Formulations for Topical Treatment of Skin Hyperandrogenic Disorders and Chronic Wounds. Pharmaceutics. 2024 Dec 27;17(1):27. doi: 10.3390/pharmaceutics17010027.
PubMed 39861676Zhu Z, Zhong X, Luo Z, Liu M, Zhang H, Zheng H, Li J. Global, regional and national burdens of acne vulgaris in adolescents and young adults aged 10-24 years from 1990 to 2021: a trend analysis. Br J Dermatol. 2025 Jan 24;192(2):228-237. doi: 10.1093/bjd/ljae352.
PubMed 39271178
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Topical 5% Spironolactone Gel Nano-Formulation Versus 0.1% Adapalene Gel in the Management of Acne Vulgaris: A Split-Face Study
- ClinicalTrials.gov ID
- NCT07473895
- Acronym / sponsor ID
- AUN-DERM-ACNE-2026
- Conditions
- Acne Vulgaris
- Keywords
- Acne vulgaris, Spironolactone, Adapalene, Topical therapy, Split-face study, Antiandrogen thearapy, Nano-Formulation, Dermatology
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 16 Mar 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.
Acne vulgaris is one of the most common dermatological conditions affecting adolescents and young adults. It results from multiple pathogenic factors, including increased sebum production, follicular hyperkeratinization, colonization by Cutibacterium acnes, and inflammation. Topical retinoids such as adapalene are widely used as first-line therapy; however, they may cause irritation and are not always effective in all patients. Recently, topical antiandrogen therapies such as spironolactone have gained attention because of their ability to reduce sebum production and improve acne lesions.
This study aims to evaluate the efficacy and safety of a topical 5% spironolactone gel nano-formulation compared with 0.1% adapalene gel in the treatment of acne vulgaris. A split-face study design will be used in which each participant will receive spironolactone gel on one side of the face and adapalene gel on the other side. This design allows each participant to serve as their own control and helps reduce variability in treatment response.
Participants diagnosed with acne vulgaris will be enrolled and treated for a defined follow-up period. Clinical assessment will be performed at baseline and during scheduled follow-up visits to evaluate improvement in acne lesions and monitor possible adverse effects. The primary outcomes will include changes in acne lesion counts and clinical severity scores. Safety and tolerability of both treatments will also be assessed.
The results of this study may provide evidence regarding the effectiveness of topical spironolactone nano-formulation as a potential alternative or adjunct therapy for acne vulgaris.
Detailed description
Acne vulgaris is a chronic inflammatory disorder of the pilosebaceous unit that affects a large proportion of adolescents and young adults worldwide. The condition is characterized by the development of comedones, papules, pustules, and in severe cases nodules and cysts. The pathogenesis of acne involves multiple mechanisms including follicular hyperkeratinization, excessive sebum production stimulated by androgens, colonization with Cutibacterium acnes, and inflammatory responses within the pilosebaceous unit.
Topical retinoids are considered a cornerstone in the management of acne vulgaris due to their comedolytic and anti-inflammatory properties. Adapalene, a third-generation topical retinoid, is commonly used because of its efficacy and relatively favorable tolerability profile. Despite these advantages, some patients experience skin irritation, dryness, and erythema, which may limit adherence and treatment outcomes.
Spironolactone is an antiandrogen medication traditionally used orally for the treatment of hormonal acne, particularly in females. It acts by blocking androgen receptors and reducing sebaceous gland activity, thereby decreasing sebum production. However, systemic administration may be associated with potential adverse effects. Topical formulations of spironolactone have been proposed as an alternative approach to deliver antiandrogen effects locally while minimizing systemic exposure.
Recent advances in pharmaceutical technology, including nano-formulation delivery systems, may enhance the penetration and stability of topical medications and improve therapeutic outcomes. A topical 5% spironolactone gel nano-formulation may provide improved skin penetration and targeted delivery to the pilosebaceous unit.
The present study is designed as a split-face comparative clinical study to evaluate the efficacy and safety of topical 5% spironolactone gel nano-formulation compared with topical 0.1% adapalene gel in patients with acne vulgaris. In this design, each participant will apply spironolactone gel to one side of the face and adapalene gel to the other side according to the study protocol. This approach allows direct comparison of the two treatments within the same individual and minimizes inter-individual variability.
Eligible participants diagnosed with acne vulgaris will be recruited from dermatology clinics. Baseline clinical assessment will include evaluation of acne severity, lesion counts, and skin examination. Participants will receive instructions regarding the application of each topical treatment and follow-up visits will be scheduled throughout the study period to monitor treatment response and detect possible adverse events.
The primary outcome will be the change in acne lesion counts and clinical severity after the treatment period. Secondary outcomes will include evaluation of treatment tolerability, improvement in inflammatory and non-inflammatory lesions, and documentation of local adverse reactions such as erythema, dryness, burning sensation, or irritation.
The findings of this study may contribute to the growing body of evidence regarding topical antiandrogen therapy for acne and may support the use of spironolactone nano-formulation as an effective and safe topical treatment option for patients with acne vulgaris.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants with acne vulgaris will be enrolled in a split-face comparative study. Each participant will apply topical 5% spironolactone nano-formulation gel to one side of the face and topical 0.1% adapalene gel to the opposite side. This design allows each participant to serve as their own control and enables direct comparison of treatment efficacy and safety between the two topical therapies.
| Arm | Type | Receives |
|---|---|---|
| Topical 5% Spironolactone Gel nano-formulation. | Experimental | Drug: Spironolactone 5% Topical GelParticipants will apply topical 5% spironolactone nano-formulation gel to one side of the face once daily during the study period to evaluate its efficacy and safety in the treatment of acne vulgaris. |
| Topical 0.1% Adapalene Gel | Active comparator | Drug: Adapalene 0.1% Topical GelParticipants will apply topical 0.1% adapalene gel to the opposite side of the face once daily during the study period for comparison of efficacy and safety. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age: 18-45 years old.
- Patients with mild to moderate bilateral acne vulgaris on the face.
- Presence of non-inflammatory acne (open and closed comedones).
- Presence of inflammatory papules and pustules.
Key exclusion criteria (4 listed)
- Pregnancy and lactation.
- Patients taking oral contraceptive pills or any hormonal treatment.
- Patients who were using topical or systemic medications for acne in the last two months prior to starting therapy.
- Patients who had received laser resurfacing, chemical peeling, mesotherapy, or any similar facial interventions.
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 |
|---|---|---|
| Spironolactone 5% Topical GelAlso: Topical Spironolactone, Spironolactone Nano-Gel, Spironolactone 5% GelThis is a drug-loaded nanospanlastics dispersion (using Span 60 and Tween 40) fabricated via the ethanol injection technique. It is applied twice daily to one half of the face for 8 weeks. | Drug | Topical 5% Spironolactone Gel nano-formulation. |
| Adapalene 0.1% Topical GelAlso: Topical Adapalene, Adapalene Gel, Adapalene 0.1%A third-generation retinoid applied once daily at night to the opposite half of the face. | Drug | Topical 0.1% Adapalene Gel |
Primary outcome
Measure the Change in Acne Severity via Global Acne Grading System (GAGS)
Time frame: Baseline and 8 weeks (end of treatment)
The GAGS is used to calculate acne severity separately for each half of the face. The face is divided into regions (forehead, cheeks, nose, chin) with assigned area factors. Each region is graded from 0 (no lesion) to 4 (nodule); the regional score is the product of the most severe lesion grade and the area factor
4 secondary outcomes
Measure Comparative Change in Global Acne Grading System (GAGS) Score
Time frame: 8 weeks
Measure The Reduction in Total Lesion Count (TLC)
Time frame: Baseline and 8 weeks
Measure Change in Quality of Life Using the Cardiff Acne Disability Index (CADI)
Time frame: Baseline and 8 weeks.
Measure Patient Treatment Satisfaction Assessed by the Dermatology Treatment Satisfaction Questionnaire (DermSat-7)
Time frame: 8 weeks
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 17 Mar 2026.
- Background: PubMed 17635508Charakida A, Charakida M, Chu AC. Double-blind, randomized, placebo-controlled study of a lotion containing triethyl citrate and ethyl linoleate in the treatment of acne vulgaris. Br J Dermatol. 2007 Sep;157(3):569-74. doi: 10.1111/j.1365-2133.2007.08083.x. Epub 2007 Jul 16.
- Background: PubMed 40475110Elradi M, Hamed DE, Eltwansy MS, Hosny D. The Impact of Acne on Quality of Life: A Cross-Sectional Study from Egypt. Skin Appendage Disord. 2025 Jun;11(3):255-261. doi: 10.1159/000543051. Epub 2024 Dec 10.
- Background: PubMed 38576244Bae IH, Kwak JH, Na CH, Kim MS, Shin BS, Choi H. A Comprehensive Review of the Acne Grading Scale in 2023. Ann Dermatol. 2024 Apr;36(2):65-73. doi: 10.5021/ad.23.094.
- Background: PubMed 37991774Shields A, Armstrong AW, Kaur MN, Layton A, Thiboutot D, Tan J, Barbieri JS. Evaluation of DermSat-7 for Assessing Treatment Satisfaction in Patients with Acne. JAMA Dermatol. 2024 Jan 1;160(1):88-92. doi: 10.1001/jamadermatol.2023.4481.
- Background: PubMed 38725769Althwanay A, AlEdani EM, Kaur H, Kasapoglu M, Yadavalli R, Nawaz S, Nath TS. Efficacy of Topical Treatments in the Management of Mild-to-Moderate Acne Vulgaris: A Systematic Review. Cureus. 2024 Apr 9;16(4):e57909. doi: 10.7759/cureus.57909. eCollection 2024 Apr.
- Background: PubMed 39861676Dereiah S, Ghori MU, Conway BR. A Systematic Review of Spironolactone Nano-Formulations for Topical Treatment of Skin Hyperandrogenic Disorders and Chronic Wounds. Pharmaceutics. 2024 Dec 27;17(1):27. doi: 10.3390/pharmaceutics17010027.
- Background: PubMed 39271178Zhu Z, Zhong X, Luo Z, Liu M, Zhang H, Zheng H, Li J. Global, regional and national burdens of acne vulgaris in adolescents and young adults aged 10-24 years from 1990 to 2021: a trend analysis. Br J Dermatol. 2025 Jan 24;192(2):228-237. doi: 10.1093/bjd/ljae352.
- WHO Unified Medical Dictionary used for Arabic terminology in the study.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
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 Spironolactone 5% Topical Gel and Adapalene 0.1% Topical Gel in people with Acne Vulgaris, run by Assiut 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 4 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: opening soon, as of the sponsor's last update on 17 Mar 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 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. 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 Mai Ahmed Ahmed (01123095269, Mai1998530@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure the Change in Acne Severity via Global Acne Grading System (GAGS) (time frame: Baseline and 8 weeks (end of treatment)). 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 NCT07473895, which also lists 7 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 17 Mar 2026.